Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-01-04 @ 5:30 AM
Study NCT ID:
NCT04053361
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2019-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Catheter Ablation of Atrial Fibrillation in Patients With Pulmonary Hypertension Hypertension: a Randomised Study
Sponsor:
General University Hospital, Prague
Organization:
Study Overview
Official Title:
Catheter Ablation of Atrial Fibrillation/Tachycardia in Patients With Pulmonary Hypertension: a Randomised Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: