Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein IsolationREDE-AFNCT05817318
Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation
A study testing Renal Denervation in people with Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation
- What is being tested?
- Renal Denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 27 Jun 2023to 23 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Universitätsspital Basel
Basel, 4031
Inselspital Bern
Bern, 3010
About this study
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
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.
Read the 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.
- Being tested
- Renal Denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationDevice
Arrhythmia burden pre-to-post renal denervation as assessed by an implantable cardiac monitor
| Study group | Role | What they receive |
|---|---|---|
| Pre-to-post renal denervation treatment | Other | Pre-to-post treatment comparison Receives: Device: Renal Denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (13)
Freedom from atrial fibrillation recurrence
Freedom from atrial fibrillation recurrence at 12 months after renal denervation
Measured: 12 months
Time to first atrial fibrillation recurrence after renal denervation
Measured: 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.
Measured: 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
Measured: 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
Measured: 3 years
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).
Measured: 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).
Measured: 12 months
Change in day heart rate following renal denervation
Day heart rate following renal denervation compared to before, as assessed by the ICM.
Measured: 12 months
Change in patient activity
Patient activity following renal denervation compared to before, as assessed by the ICM
Measured: 12 months
Change in heart rate variability
Heart rate variability following renal denervation compared to before, as assessed by the ICM.
Measured: 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).
Measured: 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).
Measured: 12 month
Change in night heart rate following renal denervation
Night heart rate following renal denervation compared to before, as assessed by the ICM.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start27 Jun 2023
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Why it stopped: Study prematurely terminated by 23.09.2025 due to very slow patient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein IsolationStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Laurent Roten, Prof, Principal investigator, Insel Gruppe AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817318
- Sponsor's protocol ID
- REDE-AF
- Acronym
- REDE-AF
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05817318
- Acronym / sponsor ID
- REDE-AF / REDE-AF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study prematurely terminated by 23.09.2025 due to very slow patient recruitment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-to-post renal denervation treatment | Other | Device: Renal DenervationPre-to-post treatment comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal DenervationArrhythmia burden pre-to-post renal denervation as assessed by an implantable cardiac monitor | Device | Pre-to-post renal denervation treatment |
Primary outcome
Change in atrial fibrillation burden
Time frame: 6 months
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.
13 secondary outcomes
Freedom from atrial fibrillation recurrence
Time frame: 12 months
Time to first atrial fibrillation recurrence after renal denervation
Time frame: 12 month
Change in mean number of days with atrial fibrillation
Time frame: 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
Time frame: 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
Time frame: 3 years
Change in arterial blood pressure after renal denervation
Time frame: 3 months
Change in arterial blood pressure after renal denervation
Time frame: 12 months
Change in day heart rate following renal denervation
Time frame: 12 months
Change in patient activity
Time frame: 12 months
Change in heart rate variability
Time frame: 12 months
Change in arterial blood pressure after renal denervation
Time frame: 3 months
Change in arterial blood pressure after renal denervation
Time frame: 12 month
Change in night heart rate following renal denervation
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study prematurely terminated by 23.09.2025 due to very slow patient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Roten, Prof principal investigator
Insel Gruppe AG
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Denervation in people with Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study prematurely terminated by 23.09.2025 due to very slow patient recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in atrial fibrillation burden (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.