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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P240006 / PAS001 |
| Date Original Protocol Accepted |
05/09/2025
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| Date Current Protocol Accepted |
05/09/2025
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| Study Name |
VP PAS
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| Device Name |
VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)
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| Clinical Trial Number(s) |
NCT06056557
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, non-randomized, multi-center, observational study of the Biosense Webster VARIPULSE™ Catheter system to evaluate long term safety and effectiveness for the treatment of symptomatic paroxysmal atrial fibrillation (PAF).
The study will enroll 276 adult subjects (age = 22 years) who intend to undergo their de novo pulmonary vein isolation (PVI) using the VARIPULSE™ Catheter system.
After the study ablation procedure, subjects will enter a 2-month blanking period (Day 0-60) followed by a 36-month evaluation period (Days 61-1095).
The primary objective of this clinical investigation is to evaluate the long-term safety and effectiveness of the VARIPULSE™ Catheter system for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic PAF.
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| Study Population |
Subjects undergoing electrophysiology mapping and pulsed field ablation (PFA) for treatment of symptomatic PAF refractory, intolerant, or contraindicated to at least one Class I or Class III antiarrhythmic drugs (AADs).
Of the enrolled subjects, a subset of 40 subjects will undergo echocardiography imaging at baseline and 12 month post index procedure for assessment of ventricular wall motion abnormality.
Inclusion Criteria
1. Symptomatic paroxysmal AF (episode terminates spontaneously within 7 days) who, in the opinion of the investigator, are candidates for catheter ablation for AF.
2. Refractory, intolerant, or contraindicated to Class I/III AAD
3. Age = 22 years
4. Willing and capable of providing consent
5. Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion Criteria
1. Previously diagnosed with persistent or long-standing persistent AF (> 7 days in duration)
2. Previous surgical or catheter ablation for AF
3. Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF.
4. Current enrollment in an investigational study evaluating another device or drug.
5. Life expectancy less than 12 months
6. Any contraindications noted in the clinical investigation protocol.
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| Sample Size |
Number of subjects: 276
Assumptions for sample size estimation:
• At least 50% female subjects.
• Each site to contribute no more than 15% of target enrollment.
Number of sites: Up to 30
Sites’ location: United States
Total duration: Approximately 24 months of enrollment and 36 months of follow-up. The targeted enrollment timeline following first site activation is as follows:
• First subject enrolled within 6 months.
• 20% of subjects enrolled within 12 months.
• 50% of subjects enrolled within 18 months.
• 1000% of subjects enrolled within 24 months.
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| Key Study Endpoints |
Safety Endpoints
Primary: The primary safety endpoint is the occurrence of early onset PAEs (within seven days of the index ablation procedure, unless otherwise indicated using the VARIPULSE™ Catheter system). PAEs include the following:
• Esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula).
• Cardiac tamponade/perforation.
• Death (device or procedure related).
• Major vascular access complication/bleeding.
• Myocardial infarction (MI).
• Pericarditis.
• Heart block.
• Phrenic nerve paralysis (permanent).
• Pulmonary vein stenosis.
• Stroke/cerebrovascular accident (CVA).
• Thromboembolism.
• Transient ischemic attack (TIA).
• Pulmonary edema (respiratory insufficiency.
• Vagal nerve injury/gastroparesis.
Secondary:
• Occurrence of the following procedure- and/or device-related safety events:
o Cardiac tamponade/perforation in women undergoing PAF ablation using the VARIPULSE™ Catheter system.
o Early mortality occurring within 3 months following ablation procedure using the VARIPULSE™ Catheter system.
o Cardiac arrest occurring following ablation procedure using the VARIPULSE™ Catheter system.
o Renal failure occurring within 30 days following ablation procedure using the VARIPULSE™ Catheter system.
o Occurrence of serious device- or serious procedure-related adverse events within 12 months following ablation procedure using the VARIPULSE™ Catheter system.
o Occurrence of new ventricular wall motion abnormality seen on echocardiogram within 15 months following index ablation procedure using the VARIPULSE™ Catheter system for subjects in the transthoracic echocardiogram (TTE).
o Occurrence of unanticipated adverse device effects (UADEs).
Effectiveness Endpoints
Primary: The primary effectiveness endpoint is freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (AF, atrial tachycardia (AT), or atrial flutter (AFL) of unknown origin*) episodes during the effectiveness evaluation period (Day 61-1095 post-index procedure).
*AFL of unknown origin is defined as all AFL except those cavotricuspid isthmus-dependent AFL as confirmed by 12-lead electrocardiogram (ECG) and entrainment maneuvers in an electrophysiology (EP) study.
Secondary:
• Occurrence of the following procedure- and/or device-related safety events:
o Acute procedural success
o 12 month and 24 month effectiveness success
o 36 month clinical success
o 12 month, 24 month, and 36 month effectiveness success off class I/III AAD
o 36 month effectiveness success and freedom from additional failure modes
o First Pass Isolation
o Non-study Catheter Use
o Repeat Ablation Procedures
o Procedural efficiency
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| Follow-up Visits and Length of Follow-up |
Study and follow-up visits will be performed at pre-ablation, procedure, pre-discharge, 2 months, 6 months, 12 months, 24 months, and 36 months. Transthoracic echocardiogram will be collected at 12 months.
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