Status:
COMPLETED
Discerning Symptomatic and Asymptomatic Episodes Pre and Post Radiofrequency Ablation of Atrial Fibrillation
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial Fibrillation (AF) is a common heart rhythm problem that can be eliminated by a radiofrequency ablation procedure. The purpose of this study is to assess the amount of AF that occurs before and ...
Detailed Description
Patients scheduled to undergo a first time ablation for AF will be implanted with an implantable loop recorder (ILR), capable of automatically recording episodes of AF, 3 months prior to their ablatio...
Eligibility Criteria
Inclusion
- Age \> 18 years old.
- First-time ablation procedure for AF.
- Symptomatic AF which has been refractory to at least one antiarrhythmic medication. "Symptomatic" patients should be patients who feel that they are aware of when they are in or out of AF. Symptoms may include palpitations, shortness of breath, chest pain, fatigue, or other symptoms, or any combination of the symptoms listed above.
- Patients must have paroxysmal or persistent AF. Paroxysmal patients should have had at least 4 episodes of AF in the 6 months prior to assessment/ablation. Paroxysmal AF is defined as AF which spontaneously terminates within 7 days. Persistent AF is defined as AF which sustains for longer than 7 days, or AF lasting less than 7 days which requires either pharmacologic or electrical cardioversion.
- At least one episode of AF must have been documented by ECG or Holter within 12 months of inclusion in the study.
- No contraindication to systemic anticoagulation with heparin or coumadin.
- Patients must be able and willing to provide written informed consent to participate in the study.
Exclusion
- Patients with permanent atrial fibrillation. Permanent AF is defined as chronic, persisting AF (typically more than 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 or may potentially be pregnant.
- Left atrial size \> or equal to 55 mm.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00745706
Start Date
September 1 2008
End Date
December 1 2014
Last Update
October 2 2019
Active Locations (8)
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1
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia, Canada, V8R 4R2
2
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
3
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada, L8L 2X2
4
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5