Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects with Persistent or Long Standing Persistent Atrial Fibrillation with Radiofrequency Ablatio
Phase 3
Suspended
- Conditions
- atrial fibrillationfibrillation10007521
- Registration Number
- NL-OMON47579
- Lead Sponsor
- Atricure Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Patients with symptomatic (e.g. palpitations, shortness of breath, fatigue)
Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation
refractory to a minimum of one Class I or Class III AADs.
Exclusion Criteria
Patient has undergone prior cardiothoracic surgery (lungs or mediastinum).
Patient has NYHA Class IV heart failure.
Patient has an ejection fraction < 30% (based on baseline transthoracic
echocardiography or equivalent diagnostic test).
Patient has evidence of underlying Coronary Artery Disease requiring
intervention (either surgical, i.e. CABG, or catheter).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method