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Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
NCT00971204 · View on ClinicalTrials.gov ↗
Study Summary
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
Conditions Studied
Interventions
- DEVICE CardioFocus HeartLight Endoscopic Ablation System
Study Locations (10)
Texas
- Texas Cardiac Arrhythmia Research Foundation — Austin
- The Methodist Hospital Research Institute — Houston
Virginia
- University Of Virginia Health System — Charlottesville
- Sentara Norfolk General Hospital — Norfolk
Alabama
- University of Alabama at Birmingham — Birmingham
California
- Pacific Heart Institute — Santa Monica
Michigan
- William Beaumont Hospital — Royal Oak
New York
- Mt. Sinai Hospital — New York
Pennsylvania
- University of Pennsylvania Health System — Philadelphia
South Carolina
- Medical University of South Carolina — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00971204
The ClinicalTrials.gov registry entry for NCT00971204 describes a study currently listed as completed. It is categorized as Phase 2, 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 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CardioFocus, which has 2 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 appearing as the primary indexed condition, and to 1 intervention — of which CardioFocus HeartLight Endoscopic Ablation 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: NCT00971204 reports 10 study locations spanning 8 distinct geographic areas — top geographies include Texas, Virginia, 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 NCT00971204 about?
NCT00971204 is a clinical study titled "Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation". This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
What is the current status of trial NCT00971204?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2009-09. Estimated completion is 2012-06.
What conditions does trial NCT00971204 study?
This clinical trial studies the following conditions: Paroxysmal 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 NCT00971204?
The interventions under investigation include: CardioFocus HeartLight Endoscopic Ablation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00971204?
This trial is sponsored by CardioFocus, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00971204 being conducted?
This trial has 10 study locations across Alabama, California, Michigan, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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