Status:
COMPLETED
Selective Complex Fractionated Atrial Electrograms (CFAE) Targeting for Atrial Fibrillation
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will be a multicenter, open, prospective, randomized trial. Patients with either paroxysmal or persistent atrial fibrillation will be considered for the study. (For US, only paroxysmal atri...
Detailed Description
The purpose of this study is to compare a strategy of targeted CFAE ablation, focusing on regions of continuous electrical activity versus a strategy of generalized CFAE ablation in terms of (1) acute...
Eligibility Criteria
Inclusion
- Candidates for this study must meet ALL of the following criteria:
- Age ≥ 18 years old
- First-time ablation procedure for AF
- Symptomatic AF which has been refractory to at least one antiarrhythmic medication (AAD). "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the above
- One of the following must apply:
- AF must either be PERSISTENT AF (non-US sites only) or HIGH BURDEN PAROXYSMAL AF - High burden paroxysmal AF is defined as episodes that terminate within 30 days and meet any ONE of the following criteria:
- More than 1 episode of AF per month in the preceding 6 months with at least 1 episode lasting \>24 hours by symptoms,
- LA size of \>/= 48 mm in the PLAX (parasternal long axis) view on echocardiography
- LA volume \>/= 100 cc
- Total AF history \>/= 10 years
- At least one episode of AF must have been documented by ECG, Holter, TTM, or telemetry strip within 24 months of inclusion in the study.
- Patients must be able and willing to provide written informed consent to participate in the study.
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion
- Candidates will be excluded from the study if any of the following conditions apply:
- Patients with long-standing persistent AF \>1 year for which cardioversion (pharmacologic or electrical) has failed or will never be attempted.
- Patients with AF felt to be secondary to an obvious reversible cause.
- Patients with contraindications to systemic anticoagulation with heparin or Coumadin.
- Patients who have previously undergone atrial fibrillation ablation.
- Patients who are pregnant (by history of menses or pregnancy test if history is considered unreliable.
- Left atrial size ≥55 mm (PLAX view on echocardiography).
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00926783
Start Date
August 1 2009
End Date
September 1 2013
Last Update
June 10 2014
Active Locations (7)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia
4
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada