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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04053361
• Other study ID #: GH-18-02-00027-0-202
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: General University Hospital, Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Procedure:
• Catheter ablation
Catheter ablation of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy.

Locations

Country	Name	City	State
Czechia	FN Olomouc	Olomouc
Czechia	General University Hospital in Prague	Prague
Czechia	IKEM	Prague

Sponsors (1)

Lead Sponsor	Collaborator
General University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

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 rando — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia recurrence	Documented arrhythmia recurrence >30 s without antiarrhythmic drugs in post-blanking period after the index ablation	3 months
Secondary	On-drugs arrhythmia recurrence	Documented on-drugs arrhythmia recurrence	3 months
Secondary	Symptoms of arrhythmia	Symptoms of arrhythmia by questionare	3 months
Secondary	Change in Quality of life	EQ5D	6 months
Secondary	Mortality	Mortality of any cause	3 months
Secondary	Procedure-related complication rate	Complications related to catheter ablation	1 day (Once)
Secondary	Reablation	Number of repeat catheter ablations if symptoms are ongoing	3 months