Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-30 @ 10:26 PM
Study NCT ID:
NCT05760833
Status:
WITHDRAWN
Last Update Posted:
2024-05-17
First Post:
2022-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ablation in Patients With HF and Symptomatic AF: PULVERISE-AF-CRT
Sponsor:
University Medical Center Groningen
Organization:
Study Overview
Official Title:
Pulmonary Vein Isolation or Atrioventricular Node Ablation in Patients With Heart Failure and Symptomatic Atrial Fibrillation Diminishing CRT Response (PULVERISE-AF-CRT): a Randomized Study
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary vein isolation (PVI) is currently the cornerstone non pharmacological therapy for drug-refractory atrial fibrillation (AF). Where rhythm control has been shown to be inferior as compared to rate control in older trials. New data suggest that for patients with heart failure and AF PVI may improve prognosis (mortality) as compared to medical rate or rhythm control. Whether optimal rate control as can be achieved with atrioventricular node ablation is comparable with regard to all-cause mortality of heart failure hospitalization to PVI in patients with heart failure and AF is unknown.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: