Clinical trial NCT04053361: Catheter Ablation of Atrial Fibrillation in Patients With Pulmonary Hypertension Hypertension: a Randomised Study
Official title: Catheter Ablation of Atrial Fibrillation/Tachycardia in Patients With Pulmonary Hypertension: a Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Pulmonary Hypertension
Keywords: Atrial Fibrillation
Pulmonary Hypertension
Catheter Ablation
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Arrhythmia recurrence
timeFrame: 3 months
Secondary outcomes:
measure: On-drugs arrhythmia recurrence
timeFrame: 3 months
measure: Symptoms of arrhythmia
timeFrame: 3 months
measure: Change in Quality of life
timeFrame: 6 months
measure: Mortality
timeFrame: 3 months
measure: Procedure-related complication rate
timeFrame: 1 day (Once)
measure: Reablation
timeFrame: 3 months
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: FN Olomouc
city: Prague
country: Czechia
facility: IKEM
city: Prague
country: Czechia
facility: General University Hospital in Prague
Study officials:
References:
citation: Havranek S, Fingrova Z, Skala T, Reichenbach A, Dusik M, Jansa P, Ambroz D, Dytrych V, Klimes D, Hutyra M, Kautzner J, Linhart A, Wichterle D. Catheter ablation of atrial fibrillation and atrial tachycardia in patients with pulmonary hypertension: a randomized study. Europace. 2023 May 19;25(5):euad131. doi: 10.1093/europace/euad131.