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NCT06765356 · ClinicalTrials.gov registry record · Phase 4
Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias
A Phase 4 study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, sponsored by Vivek Reddy.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 275
- Enrollment target
- 5
- Study locations
NCT06765356: Recruiting Phase 4 study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, sponsored by Vivek Reddy.
NCT06765356 is a Phase 4 study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation that is actively recruiting participants, run by Vivek Reddy. The registered enrollment target is 275 participants, below the 848-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (68% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06765356, a Phase 4 study of Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, is actively recruiting participants, sponsored by Vivek Reddy.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 275 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures
Primary Outcome
Acute Procedural Success is defined as confirmation of entrance block in all targeted PVs, and acute block of all linear lesions that are attempted (eg, CTI or mitral isthmus line). (The use of a non-study catheter for PVI will be considered an effectiveness failure; however, use of a non-study catheter for ablation unrelated to PVI will be noted, but not considered a treatment failure)
Conditions Studied
Interventions
- DEVICE Farapulse Catheter System
- DRUG Low-dose Colchicine
Study Locations (5)
Arkansas
- Arrhythmia Research Group - Jonesboro
Florida
- Naples Comprehensive Health - Naples
New York
- The Mount Sinai Hospital - New York
Pennsylvania
- UPMC Pinnacle Hospitals - Harrisburg
South Carolina
- Trident Medical Center - North Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2025-04-15 |
| Est. Completion | 2027-03-30 |
| Phase | Phase 4 |
What NCT06765356 shows while recruiting
NCT06765356 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, below the 848-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (68% lower).
The record links to 3 conditions, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Farapulse Catheter System is the first listed.
NCT06765356 lists 5 locations in 5 states (Arkansas, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT06765356 about?
NCT06765356 is a clinical study titled "Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias". The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the FARAPULSE catheter system (FARAWAVE catheter used in combination with the FARASTAR generator), to treat patients with atrial fibrillation during clinically-indicated ablation procedures
What is the current status of trial NCT06765356?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 275 participants. The study started on 2025-04-15. Estimated completion is 2027-03-30.
What conditions does trial NCT06765356 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation.
What interventions are being tested in trial NCT06765356?
The interventions under investigation include: Farapulse Catheter System (DEVICE), Low-dose Colchicine (DRUG).
Who is sponsoring clinical trial NCT06765356?
This trial is sponsored by Vivek Reddy, which has 20 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06765356 being conducted?
This trial has 5 study locations across Arkansas, Florida, New York, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06765356's enrollment target sits among peer trials
275 9th of 24 higher than 16 of 24 other Paroxysmal Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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