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NCT06170606 · ClinicalTrials.gov registry record · NA
POLARx Post Approval Study (POLARx PAS)
A NA study of Paroxysmal Atrial Fibrillation, sponsored by Boston Scientific Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 11
- Study locations
NCT06170606: Recruiting NA study of Paroxysmal Atrial Fibrillation, sponsored by Boston Scientific Corporation.
NCT06170606 is a NA study of Paroxysmal Atrial Fibrillation that is actively recruiting participants, run by Boston Scientific Corporation. The registered enrollment target is 200 participants, below the 851-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (76% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06170606, a NA study of Paroxysmal Atrial Fibrillation, is actively recruiting participants, sponsored by Boston Scientific Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 11
- Study locations
Study Summary
To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillation (AF).
Primary Outcome
This measure reports the observed safety event-free rate at 12 Months follow up for all treatment and intent subjects. The safety events are a composite of procedure-related and device-related adverse events. Acute Primary Safety Endpoints include: * Death * Myocardial infarction (MI) * Persistent gastroparesis/injury to vagus nerve * Transient ischemic attack (TIA) * Stroke/Cerebrovascular accident (CVA) * Thromboembolism/ Air embolism * Cardiac tamponade/perforation * Pneumothorax * Serious v
Conditions Studied
Interventions
- DEVICE Boston Scientific Cardiac Cryoablation System
Study Locations (11)
Arizona
- Mercy Gilbert Medical Center - Gilbert
- Banner University Medical Center Phoenix - Phoenix
- Pima Heart & Vascular Clinical Research - Tucson
Colorado
- Intermountain Platte Valley Hospital - Brighton
- Valley View Hospital - Glenwood Springs
California
- Torrance Memorial Medical Center - Torrance
Florida
- St. Joseph's Hospital/BayCare Medical Group - Tampa
Ohio
- Bethesda North Hospital - Cincinnati
South Carolina
- Prisma Health Richland Hospital - Columbia
Texas
- University of Texas Medical Branch - Galveston - Galveston
Wisconsin
- Aurora Health - Grafton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-06-28 |
| Est. Completion | 2029-05 |
| Phase | NA |
What NCT06170606 shows while recruiting
NCT06170606 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 851-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Boston Scientific Cardiac Cryoablation System is the first listed.
NCT06170606 lists 11 locations in 8 states (Arizona, Colorado, California).
Frequently Asked Questions
What is clinical trial NCT06170606 about?
NCT06170606 is a clinical study titled "POLARx Post Approval Study (POLARx PAS)". To collect clinical data on safety, effectiveness and procedural success of Boston Scientific's Cardiac Cryoablation System (includes all BSC commercially available POLARx/POLARx Fit catheters) when used to perform pulmonary vein isolation (PVI) in the ablation treatment of de novo Atrial Fibrillati...
What is the current status of trial NCT06170606?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-06-28. Estimated completion is 2029-05.
What conditions does trial NCT06170606 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation.
What interventions are being tested in trial NCT06170606?
The interventions under investigation include: Boston Scientific Cardiac Cryoablation System (DEVICE).
Who is sponsoring clinical trial NCT06170606?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06170606 being conducted?
This trial has 11 study locations across Arizona, California, Colorado, Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06170606's enrollment target sits among peer trials
200 14th of 24 higher than 10 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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