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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitätsspital BaselRecruiting
  • Inselspital BernRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pre-to-post renal denervation treatment

Arm Description

Pre-to-post treatment comparison

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Freedom from atrial fibrillation recurrence
Freedom from atrial fibrillation recurrence at 12 months after renal denervation
Time to first atrial fibrillation recurrence after renal denervation
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.
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
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
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).
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).
Change in day heart rate following renal denervation
Day heart rate following renal denervation compared to before, as assessed by the ICM.
Change in patient activity
Patient activity following renal denervation compared to before, as assessed by the ICM
Change in heart rate variability
Heart rate variability following renal denervation compared to before, as assessed by the ICM.
Change in arterial blood pressure after renal denervation
Arterial blood pressure 3 months after renal denervation compared to before (office blood pressure measurements).
Change in arterial blood pressure after renal denervation
Arterial blood pressure 12 months after renal denervation compared to before (office blood pressure measurements).
Change in night heart rate following renal denervation
Night heart rate following renal denervation compared to before, as assessed by the ICM.

Full Information

First Posted
March 14, 2023
Last Updated
October 5, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT05817318
Brief Title
Renal Denervation in Patients With Recurrent Atrial Fibrillation After Successful Pulmonary Vein Isolation
Acronym
REDE-AF
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia Burden in Patients With Recurrent, Paroxysmal Atrial Fibrillation Despite Durable Pulmonary Vein Isolation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-to-post renal denervation treatment
Arm Type
Other
Arm Description
Pre-to-post treatment comparison
Intervention Type
Device
Intervention Name(s)
Renal Denervation
Intervention Description
Arrhythmia burden pre-to-post renal denervation as assessed by an implantable cardiac monitor
Primary Outcome Measure Information:
Title
Change in atrial fibrillation burden
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Freedom from atrial fibrillation recurrence
Description
Freedom from atrial fibrillation recurrence at 12 months after renal denervation
Time Frame
12 months
Title
Time to first atrial fibrillation recurrence after renal denervation
Time Frame
12 month
Title
Change in mean number of days with atrial fibrillation
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.
Time Frame
6 months
Title
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
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
Time Frame
12 months
Title
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
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
Time Frame
3 years
Title
Change in arterial blood pressure after renal denervation
Description
Arterial blood pressure 3 months after renal denervation compared to before (24-hours ambulatory blood pressure measurements).
Time Frame
3 months
Title
Change in arterial blood pressure after renal denervation
Description
Arterial blood pressure 12 months after renal denervation compared to before (24-hours ambulatory blood pressure measurements).
Time Frame
12 months
Title
Change in day heart rate following renal denervation
Description
Day heart rate following renal denervation compared to before, as assessed by the ICM.
Time Frame
12 months
Title
Change in patient activity
Description
Patient activity following renal denervation compared to before, as assessed by the ICM
Time Frame
12 months
Title
Change in heart rate variability
Description
Heart rate variability following renal denervation compared to before, as assessed by the ICM.
Time Frame
12 months
Title
Change in arterial blood pressure after renal denervation
Description
Arterial blood pressure 3 months after renal denervation compared to before (office blood pressure measurements).
Time Frame
3 months
Title
Change in arterial blood pressure after renal denervation
Description
Arterial blood pressure 12 months after renal denervation compared to before (office blood pressure measurements).
Time Frame
12 month
Title
Change in night heart rate following renal denervation
Description
Night heart rate following renal denervation compared to before, as assessed by the ICM.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Blood pressure
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 ≥10mmHg, or a decrease in systolic blood pressure to <90 mmHg
Time Frame
12 months
Title
Procedure-related complications of renal denervation
Description
Renal artery perforation or dissection requiring intervention
Time Frame
12 hours
Title
Procedure-related complications of renal denervation
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.
Time Frame
1 month
Title
Renal artery perforation or dissection requiring intervention
Description
New renal artery stenosis > 70%, confirmed by angiography
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Roten, Prof
Phone
+41 31 632 50 00
Email
kardio.studien@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Morf Laura, PhD
Phone
+41 31 632 84 79
Email
kardio.studien@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Roten, Prof
Organizational Affiliation
Insel Gruppe AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Sticherling, Prof
Phone
+41 61 556 58 10
Email
christian.sticherling@usb.ch
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Roten, Prof
Phone
+41 632 50 00
Email
kardio.studien@insel.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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