Catheter Ablation of Atrial Fibrillation in Patients With Pulmonary Hypertension Hypertension: a Randomised Study

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Pulmonary Hypertension

• Registration Number: NCT04053361
• Lead Sponsor: General University Hospital, Prague

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Arrhythmia recurrence	3 months	Documented arrhythmia recurrence \>30 s without antiarrhythmic drugs in post-blanking period after the index ablation

Secondary Outcome Measures

Name	Time	Method
On-drugs arrhythmia recurrence	3 months	Documented on-drugs arrhythmia recurrence
Symptoms of arrhythmia	3 months	Symptoms of arrhythmia by questionare
Change in Quality of life	6 months	EQ5D
Mortality	3 months	Mortality of any cause
Reablation	3 months	Number of repeat catheter ablations if symptoms are ongoing
Procedure-related complication rate	1 day (Once)	Complications related to catheter ablation

Trial Locations

Locations (3)

FN Olomouc; 🇨🇿 Olomouc, Czechia

IKEM; 🇨🇿 Prague, Czechia

General University Hospital in Prague; 🇨🇿 Prague, Czechia