Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05817318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation
Sponsor:
Insel Gruppe AG, University Hospital Bern
Organization:
Study Overview
Official Title:
Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation (REDE-AF): a National, Multi-centre, Prospective, Single-arm, Pre-to-post Treatment, Medical-device Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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:
REDE-AF
Brief Summary:
The aim of this study is to investigate whether renal denervation can reduce arrhythmia burden in patients with recurrent, paroxysmal atrial fibrillation despite durable pulmonary vein isolation.
Detailed Description:
Pulmonary vein isolation is the treatment of choice in symptomatic patients with paroxysmal atrial fibrillation. Despite durable pulmonary vein isolation, 15% of patients continue to have episodes of atrial fibrillation because of triggers of atrial fibrillation localized outside the pulmonary veins. Additional ablation of these triggers is difficult because they often cannot be localized. The autonomous nervous system does influence these triggers and modulation of the autonomous nervous system with the goal to reduce sympathetic activity may be an alternative approach to suppress these extra-pulmonary vein triggers. Renal denervation does reduce sympathetic activity and is successfully used to treat drug-resistant arterial hypertension. The combination of pulmonary vein isolation with renal denervation has already been shown to be superior to pulmonary vein isolation alone in patients with paroxysmal atrial fibrillation regarding arrhythmia-free outcome. The investigators hypothesize that renal denervation can suppress atrial fibrillation in patients with recurrent episodes of paroxysmal atrial fibrillation despite durable isolation of the pulmonary veins.
The best way to assess atrial fibrillation burden is with an implantable cardiac monitor (ICM), which the investigators will use both before and after renal denervation, to gather detailed data on daily atrial fibrillation burden.
The best way to assess atrial fibrillation burden is with an implantable cardiac monitor (ICM), which the investigators will use both before and after renal denervation, to gather detailed data on daily atrial fibrillation burden.
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?: