Atrial Fibrillation, Pulmonary Hypertension
Conditions
Keywords
Atrial Fibrillation, Pulmonary Hypertension, Catheter Ablation
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.
Interventions
PROCEDURECatheter ablation
Catheter ablation of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy.
Sponsors
General University Hospital, Prague
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia recurrence | 3 months | Documented arrhythmia recurrence \>30 s without antiarrhythmic drugs in post-blanking period after the index ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of arrhythmia | 3 months | Symptoms of arrhythmia by questionare |
| Change in Quality of life | 6 months | EQ5D |
| On-drugs arrhythmia recurrence | 3 months | Documented on-drugs arrhythmia recurrence |
| Procedure-related complication rate | 1 day (Once) | Complications related to catheter ablation |
| Reablation | 3 months | Number of repeat catheter ablations if symptoms are ongoing |
| Mortality | 3 months | Mortality of any cause |
Countries
Czechia
Outcome results
None listed