Efficiency Study Evaluating the Use of PVAC Catheter Technology for Performing Ablation in Pts With Atrial Fibrillation (CAPCOST)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring radiofrequency, ablation, atrial fibrillation, PVAC
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 years or greater.
- Patients undergoing first-time catheter ablation for AF.
- Patients with paroxysmal AF. Paroxysmal AF will be defined as self-terminating episodes less than 7 days duration. Patients should have had at least 3 episodes of AF in a one year period.
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication. "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years prior to enrollment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or any combination of the above.
- At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, or transtelephonic monitoring within 24 months of enrollment in the study.
- Patients must be able and willing to provide written informed consent to participate in the clinical study.
Exclusion Criteria:
- Patients with persistent AF (defined as an episode of AF lasting >7 days).
- Patients with AF felt to be secondary to an obvious reversible cause.
- Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor.
- Patients who have previously undergone AF ablation.
- Patients with left atrial size >/= 55 mm (2D echocardiography, parasternal long axis view).
- Patients who are or may potentially be pregnant.
Sites / Locations
- Hamilton Health Sciences
- London Health Sciences Center
- Southlake Regional Health Centre
- McGill University Health Centre
- Hôpital Sacré-Coeur de Montréal
- Institut universitaire de cardiologie et de pneumologie de Québec
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control
PVAC Ablation Procedure
Radiofrequency Ablation Procedure. Subjects who are undergoing AF ablation with traditional ablation technology at the same centers by the same operators. Control patients will be enrolled in a 1:2 ratio compared to the PVAC cohort. Intervention is the use of Radiofrequency Ablation.
Intervention is the use of PVAC technology. The PVAC is deployed in the left atrium over a 0.032-inch guidewire inside the PV and advanced until it is wedged within the antrum proximal to the ostium. Energy is delivered through selected electrode pairs with local potentials as well as adjacent electrode pairs, allowing bipolar current to flow to the target electrode(s) from both sides. Each application lasts for 60 seconds. When the temperature does not rise above 50°C within 15 seconds, the application should be discontinued to improve position. The PVAC may be manipulated within the antrum to ablate in a pattern of overlapping circular lesions.