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NCT01687166 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
A NA study of Paroxysmal Atrial Fibrillation (PAF), sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 398
- Enrollment target
- 20
- Study locations
NCT01687166: Completed NA study of Paroxysmal Atrial Fibrillation (PAF), sponsored by Boston Scientific Corporation.
NCT01687166 is a NA study of Paroxysmal Atrial Fibrillation (PAF) that has completed, run by Boston Scientific Corporation. The registered enrollment target is 398 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01687166, a NA study of Paroxysmal Atrial Fibrillation (PAF), has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 398 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
Primary Outcome
The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group. The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group.
Conditions Studied
Interventions
- DEVICE Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
- DEVICE FDA Approved Open-Irrigated Ablation Catheter
Study Locations (20)
Florida
- St. Vincent's Medical Center - Jacksonville
- Baptist Hospital - Pensacola
- Tampa General Hospital - Tampa
New York
- New York University - New York
- Mt. Sinai Medical Center - New York
- Strong Memorial Hospital of the University of Rochester - Rochester
Alabama
- University of Alabama at Birmingham - Birmingham
- Hunstville Hospital - Huntsville
California
- Sequoia Hospital - Redwood City
- University of California, San Francisco - San Francisco
Georgia
- Emory University Hospital - Atlanta
- Georgia Health Sciences University - Augusta
Michigan
- University of Michigan - Ann Arbor
- William Beaumont Hospital - Royal Oak
Connecticut
- Yale University - New Haven
Maryland
- Union Memorial Hospital - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 398 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-10 |
| Phase | NA |
What the finished NCT01687166 record still lists
NCT01687166 is an interventional study that assigns participants to a tested intervention. The registered 398 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Paroxysmal Atrial Fibrillation (PAF) appearing as the primary indexed condition, and to 2 interventions - of which Blazer Open-Irrigated Ablation Catheter (Boston Scientific) is the first listed.
NCT01687166 names 20 study sites across 12 states, led by Florida, New York, Alabama.
Frequently Asked Questions
What is clinical trial NCT01687166 about?
NCT01687166 is a clinical study titled "Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation". The purpose of this study is to establish the safety and effectiveness of the Blazer Open-Irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.
What is the current status of trial NCT01687166?
This trial is currently completed. It is a NA study. The enrollment target is 398 participants. The study started on 2012-10. Estimated completion is 2016-10.
What conditions does trial NCT01687166 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation (PAF).
What interventions are being tested in trial NCT01687166?
The interventions under investigation include: Blazer Open-Irrigated Ablation Catheter (Boston Scientific) (DEVICE), FDA Approved Open-Irrigated Ablation Catheter (DEVICE).
Who is sponsoring clinical trial NCT01687166?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01687166 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01687166's enrollment target sits among peer trials
398 267th of 2000 higher than 1,734 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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