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Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias
NCT06765356 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06765356
The ClinicalTrials.gov registry entry for NCT06765356 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vivek Reddy, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06765356 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Arkansas, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Long-standing Persistent Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06765356?
The interventions under investigation include: Farapulse Catheter System (DEVICE), Low-dose Colchicine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06765356?
This trial is sponsored by Vivek Reddy, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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