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NCT07187115 · ClinicalTrials.gov registry record · NA
A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
A NA study of Atrial Fibrillation (AF) and Persistant Atrial Fibrillation, sponsored by Boston Scientific Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 699
- Enrollment target
- 20
- Study locations
NCT07187115: Recruiting NA study of Atrial Fibrillation (AF) and Persistant Atrial Fibrillation, sponsored by Boston Scientific Corporation.
NCT07187115 is a NA study of Atrial Fibrillation (AF) and Persistant Atrial Fibrillation that is actively recruiting participants, run by Boston Scientific Corporation. The registered enrollment target is 699 participants, roughly in line with the 678-participant average among 17 other Atrial Fibrillation (AF) trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07187115, a NA study of Atrial Fibrillation (AF) and Persistant Atrial Fibrillation, is actively recruiting participants, sponsored by Boston Scientific Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 699 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA of Pulmonary Veins and LA Posterior Wall (PVI+ PWA) in the treatment of de novo symptomatic drug-refractory persistent atrial fibrillation (PersAF).
Primary Outcome
The primary safety endpoint is the rate of ITT subjects in the PVI+EGF arm with one or more of the following serious device- or procedure-related Composite Adverse Events (CAEs) assessed through 60 days following the Index Procedure.
Conditions Studied
Interventions
- DEVICE FARAPOINT Pulsed Field Ablation System
- DEVICE OptiMap System (non-ablative)
- DEVICE FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System
Study Locations (20)
California
- Alta Bates Summit Medical Center - Oakland
- Stanford University Medical Center - Palo Alto
- Pacific Heart Institute - Santa Monica
Arizona
- Mercy Gilbert Medical Center - Gilbert
- Banner University Medical Center - Phoenix
Georgia
- Piedmont Athens Regional - Athens
- Emory University Hospital - Atlanta
New York
- Mount Sinai Medical Center - New York
- Good Samaritan - Suffern - Suffern
Alabama
- Grandview Medical Center - Birmingham
Arkansas
- Arrhythmia Research Group - Jonesboro
Idaho
- St. Luke's Idaho Cardiology Associates - Boise
Illinois
- Endeavor Hospital - Glenview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 699 participants |
| Start Date | 2025-11-07 |
| Est. Completion | 2030-12 |
| Phase | NA |
What NCT07187115 shows while recruiting
NCT07187115 is an interventional study that assigns participants to a tested intervention. The registered 699 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 678-participant average among 17 other Atrial Fibrillation (AF) trials with a reported enrollment target.
The record links to 2 conditions, with Atrial Fibrillation (AF) appearing as the primary indexed condition, and to 3 interventions - of which FARAPOINT Pulsed Field Ablation System is the first listed.
NCT07187115 names 20 study sites across 15 states, led by California, Arizona, Georgia.
Frequently Asked Questions
What is clinical trial NCT07187115 about?
NCT07187115 is a clinical study titled "A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation". The purpose of this study is to establish the safety of the pulsed field ablation (PFA) therapy of Pulmonary Veins and Electrographic Flow (EGF) identified extra-PV sources of atrial fibrillation (PVI + EGF ablation of sources) and to demonstrate its non-inferiority in effectiveness compared to PFA ...
What is the current status of trial NCT07187115?
This trial is currently recruiting. It is a NA study. The enrollment target is 699 participants. The study started on 2025-11-07. Estimated completion is 2030-12.
What conditions does trial NCT07187115 study?
This clinical trial studies the following conditions: Atrial Fibrillation (AF), Persistant Atrial Fibrillation.
What interventions are being tested in trial NCT07187115?
The interventions under investigation include: FARAPOINT Pulsed Field Ablation System (DEVICE), OptiMap System (non-ablative) (DEVICE), FARAPULSE Pulsed Field Ablation (PFA) System and Opal HDx Mapping System (DEVICE).
Who is sponsoring clinical trial NCT07187115?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07187115 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07187115's enrollment target sits among peer trials
699 8th of 17 higher than 10 of 17 other Atrial Fibrillation (AF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation (AF) 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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