High-Density Wave Mapping in Subjects with Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
- Conditions
- arrythmiaartrial fribrillation10007521
- Registration Number
- NL-OMON48012
- Lead Sponsor
- Abbott
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Documented atrial fibrillation with planned endocardial ablation procedure
2. Age 18 years or older
3. Able and willing to provide written informed consent prior to any clinical
investigation related procedure
4. Able and willing to complete all required study procedures through 12 months
1. Long-standing persistent atrial fibrillation defined as continuous AF
greater than 12 months in duration
2. Previous ablation or surgery in the left atria
3. Implanted left atrial appendage occluder
4. Implanted mitral or tricuspid valve replacement
5. Implanted cardiac defibrillator (ICD)
6. Participation in another clinical investigation that may confound the
results of this study
7. Pregnant or nursing
8. Presence of other anatomic or comorbid conditions, or other medical, social,
or psychological conditions that, in the investigator*s opinion, could limit
the subject*s ability to participate in the clinical investigation or to comply
with follow-up requirements, or impact the scientific soundness of the clinical
investigation results.
9. Life expectancy less than 12 months
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is one-year success, defined as freedom from AF/AFL/AT<br /><br>after removal from antiarrhythmic drug therapy as assessed from the end of the<br /><br>3-month blanking period to 12 months following a single ablation procedure.</p><br>
- Secondary Outcome Measures
Name Time Method