Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation (REDE-AF)

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

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.

Study Overview

• Status: Terminated
• Conditions: Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation
• Intervention / Treatment: Device: Renal Denervation

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Universitatsspital Basel
  • Bern, Switzerland, 3010
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• Diabetes mellitus type I
• Aortic grafts

The following exclusion criteria will apply after the run-in phase of up to 3 months duration, prospectively in patients which receive a new ICM and retrospectively in patients which already have an ICM implanted:

- Episodes of atrial fibrillation on <6 days in the 3 months run-in phase.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pre-to-post renal denervation treatment; Pre-to-post treatment comparison	Device: Renal Denervation; Arrhythmia burden pre-to-post renal denervation as assessed by an implantable cardiac monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from atrial fibrillation recurrence	Freedom from atrial fibrillation recurrence at 12 months after renal denervation	12 months
Time to first atrial fibrillation recurrence after renal denervation		12 month
Change in mean number of days with atrial fibrillation	Mean number of days with atrial fibrillation in the 6 months following renal denervation compared to the 3 months before, as assessed by the ICM.	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	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
Change in arterial blood pressure after renal denervation	Arterial blood pressure 3 months after renal denervation compared to before (24-hours ambulatory blood pressure measurements).	3 months
Change in arterial blood pressure after renal denervation	Arterial blood pressure 12 months after renal denervation compared to before (24-hours ambulatory blood pressure measurements).	12 months
Change in day heart rate following renal denervation	Day heart rate following renal denervation compared to before, as assessed by the ICM.	12 months
Change in patient activity	Patient activity following renal denervation compared to before, as assessed by the ICM	12 months
Change in heart rate variability	Heart rate variability following renal denervation compared to before, as assessed by the ICM.	12 months
Change in arterial blood pressure after renal denervation	Arterial blood pressure 3 months after renal denervation compared to before (office blood pressure measurements).	3 months
Change in arterial blood pressure after renal denervation	Arterial blood pressure 12 months after renal denervation compared to before (office blood pressure measurements).	12 month
Change in night heart rate following renal denervation	Night heart rate following renal denervation compared to before, as assessed by the ICM.	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	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	12 months
Procedure-related complications of renal denervation	Renal artery perforation or dissection requiring intervention	12 hours
Procedure-related complications of renal denervation	Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding, or distal microembolization causing visible circulatory impairment to the lower limbs) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion.	1 month
Renal artery perforation or dissection requiring intervention	New renal artery stenosis > 70%, confirmed by angiography	1 year

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Medtronic
• Investigators: Principal Investigator: Laurent Roten, Prof, Insel Gruppe AG

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Actual): September 23, 2025
• Study Completion (Actual): September 23, 2025

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Arrhythmias, Cardiac; Recurrence; Atrial Fibrillation
• Other Study ID Numbers: REDE-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No