Catheter Ablation of Atrial Fibrillation/Tachycardia in Patients With Pulmonary Hypertension: a Randomised Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- General University Hospital, Prague
- Enrollment
- 76
- Locations
- 3
- Primary Endpoint
- Arrhythmia recurrence
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Atrial fibrillation (AF) and atrial tachycardia (AT), including type I atrial flutter, are frequently observed in patients with pulmonary hypertension (PH). Catheter ablation of AF / AT has been established as an effective treatment option in selected patients. However, little is known about the efficacy and safety of this approach in patients with PH. It has also been shown that considerable proportion of patients with PH after acutely successful catheter ablation suffer from the recurrence of clinical or newly manifested arrhythmia. We propose a prospective study to compare two ablation strategies in a randomized fashion: radiofrequency catheter ablation targeting only the clinical arrhythmia versus more extensive substrate-based catheter ablation. This project will investigate the clinical outcome of patients with pulmonary hypertension and symptomatic atrial fibrillation / tachycardia who will be randomly allocated to selective versus complex radiofrequency catheter ablation of arrhythmogenic substrate.
Investigators
Stepan Havranek
Consultant
General University Hospital, Prague
Eligibility Criteria
Inclusion Criteria
- •Pre-capillary PH (PAMP ≥25 mmHg; PAWP ≤15 mmHg) or combined post- a pre-capillary PH (PAMP ≥25 mmHg; PAWP \>15 mmHg; DPG ≥7 mmHg and/or PVR \>3 W.u.) of any etiology.
Exclusion Criteria
- •Complex congenital heart defects (corrected or uncorrected)
- •Isolated post-capillary PH (PAMP ≥25 mmHg; PAWP \>15 mmHg; DPG \<7 mmHg and/or PVR ≤ 3W.u.)
- •Previous catheter ablation for AF / AT / AFL
- •Previous or scheduled cardiac surgery-
- •NYHA Class IV, cardiogenic shock
- •Life expectancy \<1 year
- •Non-compliance
Outcomes
Primary Outcomes
Arrhythmia recurrence
Time Frame: 3 months
Documented arrhythmia recurrence \>30 s without antiarrhythmic drugs in post-blanking period after the index ablation
Secondary Outcomes
- On-drugs arrhythmia recurrence(3 months)
- Symptoms of arrhythmia(3 months)
- Change in Quality of life(6 months)
- Mortality(3 months)
- Reablation(3 months)
- Procedure-related complication rate(1 day (Once))