Circumferential Versus Ganglionated Plexi Ablation for Atrial Fibrillation (AF)
NCT00671905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2013-04-11
Summary
The investigators have recently shown that anatomic ganglionated plexi (GP) ablation is inferior to circumferential pulmonary vein (PV) ablation for the treatment of paroxysmal AF. In this study, however, 26% of patients subjected to GP ablation alone without circumferential lesions were free of AF-recurrence up to one year after the ablation procedure. The investigators hypothesized that a combination of circumferential ablation with high-frequency-stimulation-identified GP ablation is superior to conventional circumferential ablation for the prevention of recurrences of paroxysmal atrial fibrillation (AF). The investigators are, therefore, conducting a randomized study comparing conventional circumferential ablation to a combination of circumferential ablation plus specific right and left atrial GP ablation in patients with drug-refractory paroxysmal AF.
Conditions
Interventions
- PROCEDURE
-
GP ablation
HF stimulation-guided and anatomic ablation of the main right and left atrial GP
- PROCEDURE
-
PV isolation
Circumferential PV isolation
Sponsors & Collaborators
-
Cardiovascular Research Society, Greece
lead OTHER
Principal Investigators
-
D Katritsis, MD · Cardiovascular Research Society
-
E Pokushalov, MD · State Research Institute of Circulation Pathology, Novosibirsk, Russia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2011-05-31
- Completion
- 2011-08-31
Countries
- Greece
- Russia
Study Locations
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