Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation

NCT05817318 | Terminated

• 1 other identifier: REDE-AF
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation

Outcome Measures

Primary Outcomes (1)

• Change in atrial fibrillation burden

  The primary endpoint is the atrial fibrillation burden in the 6 months following renal denervation compared to the 3 months before renal denervation as assessed by the ICM.

  6 months

Secondary Outcomes (13)

• Freedom from atrial fibrillation recurrence

  12 months

• Time to first atrial fibrillation recurrence after renal denervation

  12 month

• Change in mean number of days with atrial fibrillation

  6 months

• Evolution of AF burden measured as mean number of days with atrial fibrillation in the 12 months following renal denervation, as compared to before renal denervation

  12 months

• Evolution of AF burden measured as mean number of days with atrial fibrillation in the 3 years following renal denervation, as compared to before renal denervation

  3 years

Other Outcomes (4)

• Blood pressure

  12 months

• Procedure-related complications of renal denervation

  12 hours

• Procedure-related complications of renal denervation

  1 month

Study Arms (1)

Pre-to-post renal denervation treatment

OTHER

Pre-to-post treatment comparison

Device: Renal Denervation

Interventions

Renal Denervation DEVICE

Arrhythmia burden pre-to-post renal denervation as assessed by an implantable cardiac monitor

Pre-to-post renal denervation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent signed by the subject
• ≥ 18 years of age
• Recurrent, paroxysmal atrial fibrillation post repeat (≥2) pulmonary vein isolation
• Documentation of atrial fibrillation ≥3 months after the last atrial fibrillation ablation procedure by a 12-lead ECG or on a rhythm strip of ≥30 seconds duration
• Either an office systolic blood pressure ≥130 mmHg at the screening visit or antihypertensive drug therapy

You may not qualify if:

• Persistent or permanent atrial fibrillation post pulmonary vein isolation
• Left ventricular ejection fraction \<40%
• Severe aortic or mitral valve stenosis
• Treatment with amiodaron within the last 3 months
• Mandatory treatment with class I or III antiarrhythmic drugs
• History of reflex syncope, syncope due to orthostatic hypotension or unclear syncope in the past 3 years.
• History of orthostatic hypotension
• Abnormal blood pressure fall during active standing, defined as a progressive and sustained fall in systolic blood pressure from baseline value ≥20 mmHg or diastolic blood pressure ≥10mmHg, or a decrease in systolic blood pressure to \<90 mmHg.
• Prior renal denervation
• Renal artery stent or prior renal angioplasty
• Polycystic kidney disease, unilateral kidney, or history of renal transplant
• Estimated glomerular filtration rate (eGFR) \< 50mL/min, using the CKD-EPI creatinine equation (Chronic Kidney Disease Epidemiology)
• Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
• Life expectancy \<1 year
• Enrolment in interventional studies if the other study does not allow enrolment or if primary endpoint might be affected by study participation.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Medtronic: collaborator

Study Sites (2)

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Study Officials

• Laurent Roten, Prof

  Insel Gruppe AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 18, 2023
• Study Start: June 27, 2023
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)