Using renal denervation to reduce atrial fibrillation after pulmonary vein isolation
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
This study is testing whether a procedure called renal denervation can help reduce the recurring episodes of atrial fibrillation in patients who have already had a successful heart procedure to isolate their pulmonary veins.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 2 sites (Basel and 1 other locations) |
| Trial ID | NCT05817318 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of renal denervation in reducing the burden of recurrent, paroxysmal atrial fibrillation in patients who have already undergone successful pulmonary vein isolation. Despite this isolation, some patients continue to experience atrial fibrillation due to triggers outside the pulmonary veins, which are difficult to localize and treat. The study will utilize implantable cardiac monitors to assess atrial fibrillation burden before and after the renal denervation procedure. The hypothesis is that by modulating the autonomic nervous system through renal denervation, it may be possible to suppress these extra-pulmonary triggers and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with recurrent, paroxysmal atrial fibrillation following multiple pulmonary vein isolation procedures.
Not a fit: Patients with persistent or permanent atrial fibrillation or those with significant heart valve issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of atrial fibrillation episodes in affected patients.
How similar studies have performed: Previous studies have shown that combining renal denervation with pulmonary vein isolation can lead to better outcomes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Basel and 1 other locations
- Universitätsspital Basel — Basel, Switzerland (Recruiting)
- Inselspital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Laurent Roten, Prof — Insel Gruppe AG
- Study coordinator: Laurent Roten, Prof
- Email: kardio.studien@insel.ch
- Phone: +41 31 632 50 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.