Paroxysmal Atrial Fibrillation
Conditions
Keywords
paroxysmal atrial fibrillation, PAF, ablation
Brief summary
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.
Detailed description
This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. Only sites that enroll at least one subject will be part of the analysis population. No center may contribute more than 20% of the total number of enrollments without sponsor pre-approval to exceed this proportion and at least 50% of subjects must be from the United States.
Interventions
DEVICETactiCath SE
Ablation to achieve pulmonary vein isolation.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug * Physician's note indicating recurrent self-terminating AF * One electrocardiographically documented AF episode within 6 months prior to the index ablation procedure * At least 18 years of age * Able and willing to comply with all trial requirements * Informed of the nature of the trial, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.
Exclusion criteria
* Persistent or long-standing persistent atrial fibrillation (AF) * Four or more cardioversions in the past 12 months * Active systemic infection * Known presence of cardiac thrombus * Implanted with implantable cardiac defibrillator (ICD) * Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months * Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months * Left atrial diameter \> 5.0 cm * Left ventricular ejection fraction \< 35% * New York Heart Association (NYHA) class III or IV * Previous left atrial surgical or catheter ablation procedure * Left atrial surgical procedure or incision with resulting scar * Previous tricuspid or mitral valve replacement or repair * Heart disease in which corrective surgery is anticipated within 6 months * Bleeding diathesis or suspected procoagulant state * Contraindication to long term antithromboembolic therapy * Presence of any condition that precludes appropriate vascular access * Renal failure requiring dialysis * Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication * Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms * Pregnant or nursing * Presence of other anatomic or comorbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results * Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial * Patient is unlikely to survive the protocol follow up period of 12 months * Body mass index \> 40 kg/m2 * Vulnerable subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success | 0 days | The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins |
| Rate of Serious Adverse Events | 30 days | The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: * Atrial-esophageal fistula * AV block * Cardiac Perforation/ Tamponade * Death * Diaphragmatic paralysis * Gastroparesis * Hospitalization * Myocardial Infarction * Pericarditis * Pneumothorax * Pulmonary edema * Pulmonary vein stenosis * Stroke * Thromboembolism * Transient ischemic attack * Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur \>7 days post procedure through 30 days will also contribute to the primary endpoint. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Serious Adverse Events Within 30 Days | 30 days | Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint. |
| Number of Participants Experiencing a Serious Adverse Event Within 1 Year | 1 year | Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation |
| One-year Freedom From AF | 1 year | One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period. |
| One-year Drug-free Success From AF | 1 year | One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure. |
| Changes in EQ-5D-5L Utility Scores | 1 year | Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement. |
| Changes in AFEQT Scores | 1 year | Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition. |
| Health Care Utilization | 1 year | Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up. |
| Force Time Integral (FTI) | 0 days | Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated. |
| Average Power Delivered | During Procedure | This outcome is the average power delivered for a case. |
| Number of Participants With Recommended Irrigation Flow Rate Used During Procedure | 0 days | This outcome is whether or not the recommended irrigation flow rate was used for a case. |
| Contact Force During Procedure | 0 days | This outcome is the average contact force for a case. |
| Total Procedure Time | 0 days | This outcome is the total procedure time for a case. |
| Ablation Time - First to Last Ablation | 0 Days | This outcome is the total ablation time for a case. This is the time from first to last ablation. |
| Fluoroscopy Time | 0 days | This outcome is the total fluoroscopy time for a case. |
| Radiofrequency (RF) Application Time | 0 days | This outcome is the total RF application time for a case. |
| Number of Participants Using AutoMark | 0 days | This outcome is the number of cases using AutoMark. |
| Lesion Index (LSI) | 0 days | Mean lesion index (LSI) across lesions by subject Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application. |
| Average Catheter Temperature | 0 days | This outcome is the average temperature (by lesion) for a case. |
| Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force | 0 days | Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force |
Countries
Australia, Germany, Italy, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TactiCath SE Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.
TactiCath SE: Ablation to achieve pulmonary vein isolation. | 151 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Completed 30-day Visit | Missed Visit | 1 |
| Completed 30-day Visit | Withdrawal by Subject | 1 |
| Enrollment to Catheter Insertion | Adverse Event | 1 |
| Enrollment to Catheter Insertion | Did not meet inc/exc criteria | 4 |
Baseline characteristics
| Characteristic | TactiCath SE |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 76 Participants |
| Age, Categorical Between 18 and 65 years | 75 Participants |
| Age, Continuous | 65.0 years |
| BMI | 28.0 kg/m^2 STANDARD_DEVIATION 5 |
| Coronary Artery Disease | 20 Participants |
| Diabetes | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants |
| Heart Failure | 4 Participants |
| Hypertension | 80 Participants |
| Known Family History of Cardiovascular Disease | 81 Participants |
| Left Atrium Diameter | 3.8 centimeters |
| Left Ventricular Ejection Fraction | 60.7 % |
| Myocardial Infarction | 6 Participants |
| Obstructive Sleep Apnea | 20 Participants |
| Pacemaker or Implantable Cardiac Monitor | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 123 Participants |
| Region of Enrollment Australia | 22 participants |
| Region of Enrollment Germany | 21 participants |
| Region of Enrollment Italy | 12 participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 91 Participants |
| Stoke/Transient Ischemic Attack | 14 Participants |
| Structural Heart Disease | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 156 |
| other Total, other adverse events | 25 / 156 |
| serious Total, serious adverse events | 21 / 156 |
Outcome results
Primary
Number of Participants With Procedural Success
The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins
Time frame: 0 days
Population: Effectiveness Population - all subjects with device inserted into vasculature
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE - Safety Population | Number of Participants With Procedural Success | 148 Participants |
p-value: 0.0001Binomial Exact Test
Primary
Rate of Serious Adverse Events
The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: * Atrial-esophageal fistula * AV block * Cardiac Perforation/ Tamponade * Death * Diaphragmatic paralysis * Gastroparesis * Hospitalization * Myocardial Infarction * Pericarditis * Pneumothorax * Pulmonary edema * Pulmonary vein stenosis * Stroke * Thromboembolism * Transient ischemic attack * Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur \>7 days post procedure through 30 days will also contribute to the primary endpoint.
Time frame: 30 days
Population: All subjects with device inserted into vasculature and either experienced a primary endpoint event or completed 30 days of follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE - Safety Population | Rate of Serious Adverse Events | 7 Participants |
Comparison: The hypothesis is formally expressed as:~H0: P ≥ 16.2% Ha: P \< 16.2%, where P is the percentage of subjects with a primary safety endpoint event. The hypothesis will be tested based on a one-sided exact test of binomial proportions at the one-sided 0.05 alpha level.p-value: <0.0001Binomial Exact Test
Other Pre-specified
Ablation Time - First to Last Ablation
This outcome is the total ablation time for a case. This is the time from first to last ablation.
Time frame: 0 Days
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TactiCath SE - Safety Population | Ablation Time - First to Last Ablation | 84.0 minutes |
Other Pre-specified
Average Catheter Temperature
This outcome is the average temperature (by lesion) for a case.
Time frame: 0 days
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TactiCath SE - Safety Population | Average Catheter Temperature | 33.4 degrees celsius |
Other Pre-specified
Average Power Delivered
This outcome is the average power delivered for a case.
Time frame: During Procedure
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TactiCath SE - Safety Population | Average Power Delivered | 29.0 Watts |
Other Pre-specified
Changes in AFEQT Scores
Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.
Time frame: 1 year
Population: Subjects in RF population with available AFEQT data at both baseline and 12M
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TactiCath SE - Safety Population | Changes in AFEQT Scores | Change from Baseline to 3M | 25.8 score on a scale | Standard Deviation 23.8 |
| TactiCath SE - Safety Population | Changes in AFEQT Scores | Change from Baseline to 6M | 25.2 score on a scale | Standard Deviation 21.9 |
| TactiCath SE - Safety Population | Changes in AFEQT Scores | Change from Baseline to 12M | 29.1 score on a scale | Standard Deviation 23 |
Other Pre-specified
Changes in EQ-5D-5L Utility Scores
Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement.
Time frame: 1 year
Population: Subset of RF population with EQ-5D-5L data at both baseline and 12M
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TactiCath SE - Safety Population | Changes in EQ-5D-5L Utility Scores | Change in EQ-5D-5L Utility from Baseline to 3M | 0.044 score on a scale | Standard Deviation 0.108 |
| TactiCath SE - Safety Population | Changes in EQ-5D-5L Utility Scores | Change in EQ-5D-5L Utility from Baseline to 6M | 0.066 score on a scale | Standard Deviation 0.117 |
| TactiCath SE - Safety Population | Changes in EQ-5D-5L Utility Scores | Change in EQ-5D-5L Utility from Baseline to 12M | 0.032 score on a scale | Standard Deviation 0.158 |
Other Pre-specified
Contact Force During Procedure
This outcome is the average contact force for a case.
Time frame: 0 days
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TactiCath SE - Safety Population | Contact Force During Procedure | 12.1 grams | Standard Deviation 4.7 |
Other Pre-specified
Fluoroscopy Time
This outcome is the total fluoroscopy time for a case.
Time frame: 0 days
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TactiCath SE - Safety Population | Fluoroscopy Time | 9.0 minutes |
Other Pre-specified
Force Time Integral (FTI)
Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated.
Time frame: 0 days
Population: Subjects from RF population with FTI or LSI data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TactiCath SE - Safety Population | Force Time Integral (FTI) | 161.7 gram-seconds | Standard Deviation 103.7 |
Other Pre-specified
Health Care Utilization
Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up.
Time frame: 1 year
Population: Subjects with device inserted and healthcare utilization data reported
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TactiCath SE - Safety Population | Health Care Utilization | 37 Encounters |
Other Pre-specified
Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force
Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force
Time frame: 0 days
Population: Population includes all subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE - Safety Population | Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force | 5 Participants |
Other Pre-specified
Lesion Index (LSI)
Mean lesion index (LSI) across lesions by subject Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application.
Time frame: 0 days
Population: Subjects from RF population with some LSI data available
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TactiCath SE - Safety Population | Lesion Index (LSI) | 4.3 units on a scale | Standard Deviation 0.8 |
Other Pre-specified
Number of Participants Experiencing a Serious Adverse Event Within 1 Year
Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation
Time frame: 1 year
Population: Subjects with TactiCath SE inserted into vasculature
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TactiCath SE - Safety Population | Number of Participants Experiencing a Serious Adverse Event Within 1 Year | Serious AE Related to Device or Procedure | 5 Participants |
| TactiCath SE - Safety Population | Number of Participants Experiencing a Serious Adverse Event Within 1 Year | Non-Serious AE Related to Device or Procedure | 23 Participants |
Other Pre-specified
Number of Participants Experiencing Serious Adverse Events Within 30 Days
Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.
Time frame: 30 days
Population: Population includes all subjects with ablation catheter inserted.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TactiCath SE - Safety Population | Number of Participants Experiencing Serious Adverse Events Within 30 Days | Serious AE Related to Device or Procedure | 5 Participants |
| TactiCath SE - Safety Population | Number of Participants Experiencing Serious Adverse Events Within 30 Days | Non-Serious AE Related to Device or Procedure | 23 Participants |
Other Pre-specified
Number of Participants Using AutoMark
This outcome is the number of cases using AutoMark.
Time frame: 0 days
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE - Safety Population | Number of Participants Using AutoMark | 149 Participants |
Other Pre-specified
Number of Participants With Recommended Irrigation Flow Rate Used During Procedure
This outcome is whether or not the recommended irrigation flow rate was used for a case.
Time frame: 0 days
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE - Safety Population | Number of Participants With Recommended Irrigation Flow Rate Used During Procedure | 140 Participants |
Other Pre-specified
One-year Drug-free Success From AF
One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.
Time frame: 1 year
Population: The analysis population included the following subjects:~* Device inserted~* Radiofrequency energy applied~* 12M visit complete or failed endpoint
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE - Safety Population | One-year Drug-free Success From AF | 90 Participants |
Comparison: Kaplan-Meier estimate of freedom from recurrence or need for anti-arrhythmic medication95% CI: [59.9, 75.1]
Other Pre-specified
One-year Freedom From AF
One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.
Time frame: 1 year
Population: Includes subjects with the following:~* device inserted~* RF energy delivered~* Had 12M visit or failed endpoint
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TactiCath SE - Safety Population | One-year Freedom From AF | 108 Participants |
Comparison: Kaplan Meier Estimate of freedom from recurrence.95% CI: [74.7, 87.6]
Other Pre-specified
Radiofrequency (RF) Application Time
This outcome is the total RF application time for a case.
Time frame: 0 days
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TactiCath SE - Safety Population | Radiofrequency (RF) Application Time | 35.7 minutes |
Other Pre-specified
Total Procedure Time
This outcome is the total procedure time for a case.
Time frame: 0 days
Population: The population includes only subjects with at least some radiofrequency energy delivered.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| TactiCath SE - Safety Population | Total Procedure Time | 159.5 minutes |