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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '12 months', 'description': '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\n\n≥10mmHg, or a decrease in systolic blood pressure to \\<90 mmHg'}, {'measure': 'Procedure-related complications of renal denervation', 'timeFrame': '12 hours', 'description': 'Renal artery perforation or dissection requiring intervention'}, {'measure': 'Procedure-related complications of renal denervation', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Renal artery perforation or dissection requiring intervention', 'timeFrame': '1 year', 'description': 'New renal artery stenosis \\> 70%, confirmed by angiography'}], 'primaryOutcomes': [{'measure': 'Change in atrial fibrillation burden', 'timeFrame': '6 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Freedom from atrial fibrillation recurrence', 'timeFrame': '12 months', 'description': 'Freedom from atrial fibrillation recurrence at 12 months after renal denervation'}, {'measure': 'Time to first atrial fibrillation recurrence after renal denervation', 'timeFrame': '12 month'}, {'measure': 'Change in mean number of days with atrial fibrillation', 'timeFrame': '6 months', 'description': '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.'}, {'measure': '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', 'timeFrame': '12 months', 'description': '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'}, {'measure': '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', 'timeFrame': '3 years', 'description': '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'}, {'measure': 'Change in arterial blood pressure after renal denervation', 'timeFrame': '3 months', 'description': 'Arterial blood pressure 3 months after renal denervation compared to before (24-hours ambulatory blood pressure measurements).'}, {'measure': 'Change in arterial blood pressure after renal denervation', 'timeFrame': '12 months', 'description': 'Arterial blood pressure 12 months after renal denervation compared to before (24-hours ambulatory blood pressure measurements).'}, {'measure': 'Change in day heart rate following renal denervation', 'timeFrame': '12 months', 'description': 'Day heart rate following renal denervation compared to before, as assessed by the ICM.'}, {'measure': 'Change in patient activity', 'timeFrame': '12 months', 'description': 'Patient activity following renal denervation compared to before, as assessed by the ICM'}, {'measure': 'Change in heart rate variability', 'timeFrame': '12 months', 'description': 'Heart rate variability following renal denervation compared to before, as assessed by the ICM.'}, {'measure': 'Change in arterial blood pressure after renal denervation', 'timeFrame': '3 months', 'description': 'Arterial blood pressure 3 months after renal denervation compared to before (office blood pressure measurements).'}, {'measure': 'Change in arterial blood pressure after renal denervation', 'timeFrame': '12 month', 'description': 'Arterial blood pressure 12 months after renal denervation compared to before (office blood pressure measurements).'}, {'measure': 'Change in night heart rate following renal denervation', 'timeFrame': '12 months', 'description': 'Night heart rate following renal denervation compared to before, as assessed by the ICM.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed Consent signed by the subject\n* ≥ 18 years of age\n* Recurrent, paroxysmal atrial fibrillation post repeat (≥2) pulmonary vein isolation\n* 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\n* Either an office systolic blood pressure ≥130 mmHg at the screening visit or antihypertensive drug therapy\n\nExclusion Criteria:\n\n* Persistent or permanent atrial fibrillation post pulmonary vein isolation\n* Left ventricular ejection fraction \\<40%\n* Severe aortic or mitral valve stenosis\n* Treatment with amiodaron within the last 3 months\n* Mandatory treatment with class I or III antiarrhythmic drugs\n* History of reflex syncope, syncope due to orthostatic hypotension or unclear syncope in the past 3 years.\n* History of orthostatic hypotension\n* 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.\n* Prior renal denervation\n* Renal artery stent or prior renal angioplasty\n* Polycystic kidney disease, unilateral kidney, or history of renal transplant\n* Estimated glomerular filtration rate (eGFR) \\< 50mL/min, using the CKD-EPI creatinine equation (Chronic Kidney Disease Epidemiology)\n* Female of childbearing potential (age \\<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.\n* Life expectancy \\<1 year\n* Enrolment in interventional studies if the other study does not allow enrolment or if primary endpoint might be affected by study participation.\n* Diabetes mellitus type I\n* Aortic grafts\n\nThe 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:\n\n\\- Episodes of atrial fibrillation on \\<6 days in the 3 months run-in phase.'}, 'identificationModule': {'nctId': 'NCT05817318', 'acronym': 'REDE-AF', 'briefTitle': 'Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'REDE-AF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pre-to-post renal denervation treatment', 'description': 'Pre-to-post treatment comparison', 'interventionNames': ['Device: Renal Denervation']}], 'interventions': [{'name': 'Renal Denervation', 'type': 'DEVICE', 'description': 'Arrhythmia burden pre-to-post renal denervation as assessed by an implantable cardiac monitor', 'armGroupLabels': ['Pre-to-post renal denervation treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitätsspital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Laurent Roten, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Insel Gruppe AG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}