Clinical Trial to Evaluate the Treatment of Atrial Fibrillation Using the Ablation Frontiers Cardiac Ablation System
Completed
- Conditions
- atrial fibrillation heart rhythm disorder10007521
- Registration Number
- NL-OMON31777
- Lead Sponsor
- Ablation Frontiers, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
History of symptomatic permanent atrial fibrillation lasting greater than seven days but less than four years with at least one failed DC cardioversion within the previous two years.
Exclusion Criteria
Structural heart disease of clinical significance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Acute<br /><br><br /><br>- Use of AFI catheters to achieve procedure success.<br /><br>- Isolation of all accessible Pulmonary Veins<br /><br>- Elimination of CFAEs and high frequency intracardiac electrograms mapped and<br /><br>ablated with AFI catheters<br /><br>- Termination of AF upon leaving EP lab<br /><br><br /><br>Chronic<br /><br><br /><br>- Eighty percent reduction of sustained atrial fibrillation when evaluated for<br /><br>four<br /><br>consecutive days.<br /><br>- Off all rhythm control AADs at six months unless concomitant use for other<br /><br>cardiac<br /><br>disease.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Improvement of left atrial size compared to baseline.<br /><br>- Improvement of LV ejection fraction compared to baseline.<br /><br>- Improved Symptom Severity Score compared to baseline.<br /><br>- Improvement in the QoL.</p><br>