Arrhythmia, Atrial Fibrillation, Heart Diseases
Conditions
Keywords
Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Ablation, Non-randomized
Brief summary
This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Interventions
DEVICERadiofrequency Ablation
The Biosense Webster® NAVISTAR THERMOCOOL Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Sponsors
Biosense Webster, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment, one of which must be documented. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip. * Failure of at least one AAD for PAF \[class I or III or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)\] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to AAD. * Signed Patient Informed Consent Form. * Age 18 years or older. * Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion criteria
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non- cardiac cause. * Previous ablation for atrial fibrillation. * Patients on amiodarone therapy at any time during the previous six (6) months. * AF episodes that last longer than 30 days and are terminated via cardioversion. * Any valvular cardiac surgical procedure. * CABG procedure within the last 180 days (six months). * Awaiting cardiac transplantation or other cardiac surgery within the next 360 days (12 months). * Documented left atrial thrombus on imaging (e.g. TEE). * History of a documented thromboembolic event within the past one (1) year. * Diagnosed atrial myxoma. * Presence of implanted ICD. * Significant 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 chronic symptoms. * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. * Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable). * Acute illness or active systemic infection or sepsis. * Unstable angina. * Myocardial infarction within the previous 60 days (two months). * LVEF \< 40%. * History of blood clotting or bleeding abnormalities. * Contraindication to anticoagulation (i.e. heparin or warfarin). * Contraindication to CT/MRA procedure. * Life expectancy less than 360 days (12 months). * Enrollment in an investigational study evaluating another device or drug. * Uncontrolled heart failure or NYHA class III or IV heart failure. * Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation. * Presence of a condition that precludes vascular access.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361. | From study day 91 through day 361 | A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose). |
| The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events. | within 7 days of ablation procedure | Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Who Achieved Acute Success | Day 91 - 361 | Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90. |
| 24-hour Holter Data | 1 year | — |
| TTM Data | 1 year | — |
| Percentage of Subjects Who Responded to Quality of Life Assessment | 1 year | SF 36 Symptom Frequency and Severity Checklist |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NAVISTAR® THERMOCOOL® Catheter The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | NAVISTAR® THERMOCOOL® Catheter |
|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 13.2 |
| Atrial Flutter Condition With Atrial Flutter | 2 Participants |
| Atrial Flutter Condition Without Atrial Flutter | 8 Participants |
| Hypertension Condition With Hypertension | 3 Participants |
| Hypertension Condition Without Hypertension | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.
A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).
Time frame: From study day 91 through day 361
Population: The subjects who had a study ablation procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVISTAR® THERMOCOOL® Catheter | Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361. | 66.7 Percentage of participants |
Primary
The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.
Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.
Time frame: within 7 days of ablation procedure
Population: The subjects who had a study ablation procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVISTAR® THERMOCOOL® Catheter | The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events. | 0.0 Percentage of participants |
Secondary
24-hour Holter Data
Time frame: 1 year
Population: Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.
Secondary
Percentage of Subjects Who Achieved Acute Success
Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.
Time frame: Day 91 - 361
Population: The subjects who had a study ablation procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NAVISTAR® THERMOCOOL® Catheter | Percentage of Subjects Who Achieved Acute Success | 100 Percentage of participants |
Secondary
Percentage of Subjects Who Responded to Quality of Life Assessment
SF 36 Symptom Frequency and Severity Checklist
Time frame: 1 year
Population: Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.
Secondary
TTM Data
Time frame: 1 year
Population: Data not analyzed due to study termination - insufficient data to identify meaningful differences and draw significant conclusions.