Atrial Fibrillation, Paroxysmal Atrial Fibrillation
Conditions
Keywords
ablation, electrophysiology, atrial fibrillation, catheter, paroxysmal
Brief summary
The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.
Detailed description
The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being performed at multiple centers in the United States, Canada and Europe. The study will evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.
Interventions
DEVICEDiamondTemp Ablation catheter
a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
DEVICETactiCath Quartz Ablation catheter
a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study: 1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law. 2. Subjects with a history of symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF. 3. At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure. 4. Refractory to at least one Class I-IV AAD for treatment of PAF. 5. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia. 6. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment. 7. Subject is willing and able to provide written consent. STUDY
Exclusion criteria
- Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes: At time of enrollment and/or prior to procedure: 1. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause. 2. LA diameter \> 5.5 cm. 3. LVEF \< 35%. 4. Currently NYHA Class III or IV or exhibits uncontrolled heart failure. 5. BMI \> 40 kg/m2. 6. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment. 7. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation. 8. Coagulopathy, bleeding diathesis or suspected procoagulant state 9. Sepsis, active systemic infection or fever (\>100.5°F / 38°C) within a week prior to the ablation procedure. 10. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition. 11. Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study. 12. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure. 13. Positive pregnancy test results for female subjects of childbearing potential or breast feeding. 14. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes. 15. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study. 16. Life expectancy \< 12 months based on medical history or the medical judgement of the investigator. Within 1 month of enrollment or just prior to procedure: 17. Documented LA thrombus upon imaging. 18. Creatinine \>2.5mg/dl or creatinine clearance \<30mL/min. Within 2 months of enrollment: 19. Regularly (uninterrupted) prescribed amiodarone. Within 3 months of enrollment: 20. Significant GI bleed. 21. MI, unstable angina, cardiac surgery or coronary intervention. Within 6 months of enrollment: 22. CABG procedure. 23. ICD, CRT leads or pacemaker implant procedure. 24. Documented stroke, CVA, TIA or suspected neurological event. Within 12 months of enrollment: 25. An episode of AF lasting \>7 days in duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) | Within 30-days or 6-months after index ablation procedure | The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device. The primary safety device- or procedure-related SAE composite will be the combined rate of the following events: * Atrioesophageal fistula * Bleeding complication * Cardiac tamponade / perforation * Death * Extended hospitalization * Myocardial infarction * Pericarditis * Phrenic nerve paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke post-ablation * Thromboembolism * Transient ischemic attack (TIA) post-ablation * Vagal nerve injury * Vascular access complications |
| Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation). | 3-12M (3-12 months) after index ablation procedure | The primary effectiveness failure is defined by any of the following events: * Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure * Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period * DC cardioversion for AF, AFL or AT during the effectiveness evaluation period * A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period * Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period * Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period * More than one (1) repeat ablation procedure during the blanking period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From a Composite of SAE Occurring Within 7-days | Within 7-days after the index ablation procedure | Freedom from a composite of SAE occurring within 7-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. The device- or procedure-related SAE composite will be the combined rate of the following events: * Atrioesophageal fistula * Bleeding complication * Cardiac tamponade / perforation * Death * Extended hospitalization * Myocardial infarction * Pericarditis * Phrenic nerve paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke post-ablation * Thromboembolism * Transient ischemic attack (TIA) post-ablation * Vagal nerve injury * Vascular access complications |
| Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). | 3-12 months after index ablation procedure | Freedom from documented AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy. |
| Rate of Acute Procedural Success | Index ablation procedure | Rate of acute procedural success is defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV. |
| Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. | Index ablation procedure through 12-months after index ablation procedure | Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from documented AF, AT and AFL at 12 months. |
| Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. | Index ablation procedure through 12-months after index ablation procedure | Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from ALL primary effectiveness endpoint failure criteria. |
| Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) | Index ablation procedure | Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure. |
| Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire | Baseline, 6-months after index ablation and 12-months after index ablation | Accumulated changes in QOL using the AF QOL Survey (AFEQT Questionnaire) from baseline through 6 and 12 months following ablation procedure. The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire is an atrial fibrillation-specific health-related quality of life Questionnaire. The overall AFEQT score can range from 0 to 100, with 0 corresponding to complete disability and 100 corresponding to no disability. So a higher AFEQT score means a better outcome. |
| Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds) | Index ablation procedure | Mean duration of individual RF ablations (seconds) during the index ablation procedure |
| Total Procedure Time (Minutes) | Index ablation procedure | Total procedure time (minutes) at index procedure is defined as time of first assigned ablation catheter insertion into the vasculature to time of last procedural ablation catheter removed. |
| Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes) | Index ablation procedure | Time to achieve initial PVI (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation catheter until confirmation of PVI. |
| Total Treatment Device Time (Minutes) | Index ablation procedure | Total treatment device time (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation treatment catheter to removal of the treatment catheter. |
| Total Number of RF Ablations Per Procedure | Index ablation procedure | Total number of RF ablations per procedure at index procedure |
| Total Fluid Infused Through the Ablation Catheter (mL) | Index ablation procedure | Total fluid infused through the assigned ablation catheter (mL) at index procedure |
| Total Fluoroscopy Time (Minutes) | Index ablation procedure | Total fluoroscopy time (minutes) at index procedure |
| Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period | 3-12 months after index ablation procedure | Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period |
| Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) | Baseline, pre-discharge after index ablation and 12-months after index ablation procedure | Neurological changes measured using the NIH stroke scale between baseline and post-ablation (pre-discharge visit) and at 12 months post-ablation procedure. The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So a higher NIHSS score means a worse outcome. |
| Mean Cumulative RF Time Per Procedure (Minutes) | Index ablation procedure | Mean cumulative RF time per procedure (minutes) during the index ablation procedure |
Countries
Canada, Czechia, France, Italy, United States
Participant flow
Recruitment details
Enrollment/randomization occurred between 06NOV2017 and 26OCT2018 across 23 sites in the US, Canada and Europe.
Participants by arm
| Arm | Count |
|---|---|
| DiamondTemp Ablation Catheter Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter
DiamondTemp Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter | 239 |
| TactiCath Quartz Ablation Catheter Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter
TactiCath Quartz Ablation catheter: a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter | 243 |
| Total | 482 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Enrollment closed | 2 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Subject not treated with study ablation due to technical difficulties | 0 | 1 |
| Overall Study | Subject unable to complete 12-month follow-up visit | 1 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 7 |
Baseline characteristics
| Characteristic | DiamondTemp Ablation Catheter | TactiCath Quartz Ablation Catheter | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 11.1 | 63.0 years STANDARD_DEVIATION 10.4 | 62.7 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 167 Participants | 169 Participants | 336 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 66 Participants | 69 Participants | 135 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 73 Participants | 74 Participants | 147 Participants |
| Race (NIH/OMB) White | 159 Participants | 161 Participants | 320 Participants |
| Region of Enrollment Canada | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Czechia | 61 participants | 62 participants | 123 participants |
| Region of Enrollment France | 66 participants | 67 participants | 133 participants |
| Region of Enrollment Italy | 2 participants | 3 participants | 5 participants |
| Region of Enrollment United States | 109 participants | 111 participants | 220 participants |
| Sex: Female, Male Female | 103 Participants | 100 Participants | 203 Participants |
| Sex: Female, Male Male | 136 Participants | 143 Participants | 279 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 239 | 0 / 243 |
| other Total, other adverse events | 32 / 239 | 41 / 243 |
| serious Total, serious adverse events | 34 / 239 | 43 / 243 |
Outcome results
Primary
Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation).
The primary effectiveness failure is defined by any of the following events: * Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure * Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period * DC cardioversion for AF, AFL or AT during the effectiveness evaluation period * A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period * Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period * Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period * More than one (1) repeat ablation procedure during the blanking period
Time frame: 3-12M (3-12 months) after index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation). | Free from primary effectiveness failure criteria | 189 Participants |
| DiamondTemp Ablation Catheter | Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation). | Not free from primary effectiveness failure criteria | 50 Participants |
| TactiCath Quartz Ablation Catheter | Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation). | Free from primary effectiveness failure criteria | 184 Participants |
| TactiCath Quartz Ablation Catheter | Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation). | Not free from primary effectiveness failure criteria | 59 Participants |
Comparison: Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.p-value: <0.000195% CI: [-0.042, 0.109]Farrington-Manning non-inferiority test
Primary
Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)
The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device. The primary safety device- or procedure-related SAE composite will be the combined rate of the following events: * Atrioesophageal fistula * Bleeding complication * Cardiac tamponade / perforation * Death * Extended hospitalization * Myocardial infarction * Pericarditis * Phrenic nerve paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke post-ablation * Thromboembolism * Transient ischemic attack (TIA) post-ablation * Vagal nerve injury * Vascular access complications
Time frame: Within 30-days or 6-months after index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) | Free from primary safety event | 231 Participants |
| DiamondTemp Ablation Catheter | Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) | Not free from primary safety event | 8 Participants |
| TactiCath Quartz Ablation Catheter | Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) | Free from primary safety event | 227 Participants |
| TactiCath Quartz Ablation Catheter | Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) | Not free from primary safety event | 16 Participants |
Comparison: Null hypothesis: the DiamondTemp arm is inferior to the Control arm. Alternative hypothesis: the DiamondTemp arm is non-inferior to the Control arm.p-value: <0.000195% CI: [-0.0132, 0.0779]Farrington-Manning non-inferiority test
Secondary
Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire
Accumulated changes in QOL using the AF QOL Survey (AFEQT Questionnaire) from baseline through 6 and 12 months following ablation procedure. The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire is an atrial fibrillation-specific health-related quality of life Questionnaire. The overall AFEQT score can range from 0 to 100, with 0 corresponding to complete disability and 100 corresponding to no disability. So a higher AFEQT score means a better outcome.
Time frame: Baseline, 6-months after index ablation and 12-months after index ablation
Population: Subjects with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiamondTemp Ablation Catheter | Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire | Change from baseline to 6 months | 27.8 score on a scale | Standard Deviation 23.1 |
| DiamondTemp Ablation Catheter | Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire | Change from baseline to 12 months | 31.1 score on a scale | Standard Deviation 23.4 |
| TactiCath Quartz Ablation Catheter | Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire | Change from baseline to 12 months | 30.1 score on a scale | Standard Deviation 23.2 |
| TactiCath Quartz Ablation Catheter | Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire | Change from baseline to 6 months | 25.5 score on a scale | Standard Deviation 22.7 |
Secondary
Freedom From a Composite of SAE Occurring Within 7-days
Freedom from a composite of SAE occurring within 7-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. The device- or procedure-related SAE composite will be the combined rate of the following events: * Atrioesophageal fistula * Bleeding complication * Cardiac tamponade / perforation * Death * Extended hospitalization * Myocardial infarction * Pericarditis * Phrenic nerve paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke post-ablation * Thromboembolism * Transient ischemic attack (TIA) post-ablation * Vagal nerve injury * Vascular access complications
Time frame: Within 7-days after the index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Freedom From a Composite of SAE Occurring Within 7-days | Free from composite SAEs within 7 days | 231 Participants |
| DiamondTemp Ablation Catheter | Freedom From a Composite of SAE Occurring Within 7-days | Not free from composite SAEs within 7 days | 8 Participants |
| TactiCath Quartz Ablation Catheter | Freedom From a Composite of SAE Occurring Within 7-days | Free from composite SAEs within 7 days | 230 Participants |
| TactiCath Quartz Ablation Catheter | Freedom From a Composite of SAE Occurring Within 7-days | Not free from composite SAEs within 7 days | 13 Participants |
Secondary
Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs).
Freedom from documented AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy.
Time frame: 3-12 months after index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). | Free from documented AF, AT and AFL episodes in the absence of class I and III AADs | 142 Participants |
| DiamondTemp Ablation Catheter | Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). | Not free from documented AF, AT and AFL episodes in the absence of class I and III AADs | 97 Participants |
| TactiCath Quartz Ablation Catheter | Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). | Free from documented AF, AT and AFL episodes in the absence of class I and III AADs | 120 Participants |
| TactiCath Quartz Ablation Catheter | Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs). | Not free from documented AF, AT and AFL episodes in the absence of class I and III AADs | 123 Participants |
Secondary
Mean Cumulative RF Time Per Procedure (Minutes)
Mean cumulative RF time per procedure (minutes) during the index ablation procedure
Time frame: Index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Mean Cumulative RF Time Per Procedure (Minutes) | 17.9 minutes | Standard Deviation 8.1 |
| TactiCath Quartz Ablation Catheter | Mean Cumulative RF Time Per Procedure (Minutes) | 29.8 minutes | Standard Deviation 14 |
Comparison: Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different.p-value: <0.000195% CI: [-13.9, -9.8]t-test, 2 sided
Secondary
Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)
Mean duration of individual RF ablations (seconds) during the index ablation procedure
Time frame: Index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds) | 14.7 seconds | Standard Deviation 5.3 |
| TactiCath Quartz Ablation Catheter | Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds) | 32.6 seconds | Standard Deviation 25.3 |
Comparison: Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different.p-value: <0.000195% CI: [-21.2, -14.6]t-test, 2 sided
Secondary
Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS)
Neurological changes measured using the NIH stroke scale between baseline and post-ablation (pre-discharge visit) and at 12 months post-ablation procedure. The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So a higher NIHSS score means a worse outcome.
Time frame: Baseline, pre-discharge after index ablation and 12-months after index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DiamondTemp Ablation Catheter | Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) | Change from baseline to 6 months | 0 score on a scale | Standard Deviation 0.3 |
| DiamondTemp Ablation Catheter | Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) | Change from baseline to 12 months | -0.1 score on a scale | Standard Deviation 0.36 |
| TactiCath Quartz Ablation Catheter | Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) | Change from baseline to 6 months | 0 score on a scale | Standard Deviation 0.32 |
| TactiCath Quartz Ablation Catheter | Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS) | Change from baseline to 12 months | -0.1 score on a scale | Standard Deviation 0.38 |
Secondary
Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period
Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period
Time frame: 3-12 months after index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period | 0 re-hospitalization | 221 Participants |
| DiamondTemp Ablation Catheter | Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period | 1 re-hospitalization | 17 Participants |
| DiamondTemp Ablation Catheter | Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period | 2 re-hospitalizations | 1 Participants |
| TactiCath Quartz Ablation Catheter | Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period | 0 re-hospitalization | 229 Participants |
| TactiCath Quartz Ablation Catheter | Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period | 1 re-hospitalization | 13 Participants |
| TactiCath Quartz Ablation Catheter | Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period | 2 re-hospitalizations | 1 Participants |
Secondary
Rate of Acute Procedural Success
Rate of acute procedural success is defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV.
Time frame: Index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Rate of Acute Procedural Success | Acute procedural success | 228 Participants |
| DiamondTemp Ablation Catheter | Rate of Acute Procedural Success | Not acute procedural success | 11 Participants |
| TactiCath Quartz Ablation Catheter | Rate of Acute Procedural Success | Acute procedural success | 228 Participants |
| TactiCath Quartz Ablation Catheter | Rate of Acute Procedural Success | Not acute procedural success | 15 Participants |
Secondary
Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs)
Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure.
Time frame: Index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) | Occurrence of electrically reconnected PVs | 45 Participants |
| DiamondTemp Ablation Catheter | Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) | No occurrence of electrically reconnected PVs | 194 Participants |
| TactiCath Quartz Ablation Catheter | Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) | Occurrence of electrically reconnected PVs | 45 Participants |
| TactiCath Quartz Ablation Catheter | Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs) | No occurrence of electrically reconnected PVs | 198 Participants |
Secondary
Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria.
Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from ALL primary effectiveness endpoint failure criteria.
Time frame: Index ablation procedure through 12-months after index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. | Single procedure success | 175 Participants |
| DiamondTemp Ablation Catheter | Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. | Not single procedure success | 64 Participants |
| TactiCath Quartz Ablation Catheter | Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. | Single procedure success | 173 Participants |
| TactiCath Quartz Ablation Catheter | Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria. | Not single procedure success | 70 Participants |
Secondary
Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months.
Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from documented AF, AT and AFL at 12 months.
Time frame: Index ablation procedure through 12-months after index ablation procedure
Population: Intention-to-treat population: all randomized subjects are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. | Not single procedure success | 56 Participants |
| DiamondTemp Ablation Catheter | Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. | Single procedure success | 183 Participants |
| TactiCath Quartz Ablation Catheter | Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. | Not single procedure success | 58 Participants |
| TactiCath Quartz Ablation Catheter | Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months. | Single procedure success | 185 Participants |
Secondary
Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)
Time to achieve initial PVI (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation catheter until confirmation of PVI.
Time frame: Index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes) | 65.7 minutes | Standard Deviation 29.9 |
| TactiCath Quartz Ablation Catheter | Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes) | 69.4 minutes | Standard Deviation 35.2 |
Secondary
Total Fluid Infused Through the Ablation Catheter (mL)
Total fluid infused through the assigned ablation catheter (mL) at index procedure
Time frame: Index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Total Fluid Infused Through the Ablation Catheter (mL) | 332.2 mL | Standard Deviation 120.8 |
| TactiCath Quartz Ablation Catheter | Total Fluid Infused Through the Ablation Catheter (mL) | 785.2 mL | Standard Deviation 351.5 |
Secondary
Total Fluoroscopy Time (Minutes)
Total fluoroscopy time (minutes) at index procedure
Time frame: Index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Total Fluoroscopy Time (Minutes) | 12.7 minutes | Standard Deviation 10.2 |
| TactiCath Quartz Ablation Catheter | Total Fluoroscopy Time (Minutes) | 12.8 minutes | Standard Deviation 9.4 |
Comparison: Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different.p-value: 0.852895% CI: [-1.9, 1.6]t-test, 2 sided
Secondary
Total Number of RF Ablations Per Procedure
Total number of RF ablations per procedure at index procedure
Time frame: Index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Total Number of RF Ablations Per Procedure | 74.2 counts | Standard Deviation 32.9 |
| TactiCath Quartz Ablation Catheter | Total Number of RF Ablations Per Procedure | 71.1 counts | Standard Deviation 39.8 |
Secondary
Total Procedure Time (Minutes)
Total procedure time (minutes) at index procedure is defined as time of first assigned ablation catheter insertion into the vasculature to time of last procedural ablation catheter removed.
Time frame: Index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Total Procedure Time (Minutes) | 109.7 minutes | Standard Deviation 46.2 |
| TactiCath Quartz Ablation Catheter | Total Procedure Time (Minutes) | 115.4 minutes | Standard Deviation 50.8 |
Comparison: Null hypothesis: the population means for the DiamondTemp and Control groups are not different.~Alternative hypothesis: the population means for the DiamondTemp and Control groups are different.95% CI: [-14.4, 3.1]
Secondary
Total Treatment Device Time (Minutes)
Total treatment device time (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation treatment catheter to removal of the treatment catheter.
Time frame: Index ablation procedure
Population: Subjects with measure available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DiamondTemp Ablation Catheter | Total Treatment Device Time (Minutes) | 83.1 minutes | Standard Deviation 34 |
| TactiCath Quartz Ablation Catheter | Total Treatment Device Time (Minutes) | 91.4 minutes | Standard Deviation 60.9 |