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COMPLETED NA

Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

NCT01687166 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 398 participants
Start Date 2012-10
Est. Completion 2016-10
Phase NA

Sponsor

Boston Scientific Corporation

120 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01687166

The ClinicalTrials.gov registry entry for NCT01687166 describes a study currently listed as completed. It is categorized as NA, 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 398 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT01687166 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New York, Alabama. 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01687166?

This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial