Influence of Catheter-based Renal Denervation in Diseases With Increased Sympathetic Activity

Phase 1

• Conditions: Hypertension; Heart Failure; Chronic Kidney Disease; Diabetes; Heart Rhythm Disorders
• Interventions: Device: Renal denervation with Symplicity Flex Medtronic/Ardian; Device: Renal denervation with EnligHTN St. Jude Medical; Device: Renal denervation with Paradise Recor; Device: Renal denervation with V2 Vessix

• Registration Number: NCT01888315
• Lead Sponsor: University Hospital, Saarland

Brief Summary

The study is aiming to document the long-term safety and effectiveness of renal denervation in patients with hypertension and other diseases characterized by elevated sympathetic drive. Catheter-based renal denervation will be performed using CE marked, percutaneous, systems.

Detailed Description

Inclusion Criteria

1. Individual is 18 years of age.

2. Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.

3. Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

1. In the eyes of the treating physician, the renal artery anatomy would interfere with safe cannulation of the renal artery or meets local standards for surgical repair.

2. Individual has any serious medical condition, which in the opinion of the treating physician may adversely affect the safety and/or effectiveness of the participant (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, significant anemia, etc.).

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-09-04
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-24
• Last Update Submitted: 2013-06-24
• Study First Posted: 2013-06-27
• Last Update Posted: 2013-06-27
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter-based renal denervation	Renal denervation with Symplicity Flex Medtronic/Ardian	One procedure will be performed using one of the CE-marked devices for renal denervation: Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix
Catheter-based renal denervation	Renal denervation with EnligHTN St. Jude Medical	One procedure will be performed using one of the CE-marked devices for renal denervation: Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix
Catheter-based renal denervation	Renal denervation with Paradise Recor	One procedure will be performed using one of the CE-marked devices for renal denervation: Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix
Catheter-based renal denervation	Renal denervation with V2 Vessix	One procedure will be performed using one of the CE-marked devices for renal denervation: Device: Renal denervation with Symplicity Flex Medtronic/Ardian Device: Renal denervation with EnligHTN St. Jude Medical Device: Renal denervation with Paradise Recor Device: Renal denervation with V2 Vessix

Primary Outcome Measures

Name	Time	Method
Safety and efficacy of renal denervation	Baseline to 6 months	Effect on blood pressure including office, ABPM, and home-based measurements.; Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure).; Changes of antihypertensive medications.; Effects on renal function assessed with glomerular filtration rate.; Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.

Secondary Outcome Measures

Name	Time	Method
Effect of renal denervation on different organ systems.	Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months	Myocardial function and geometry using echo and MRI.; Heart rate changes and arrhythmias.; Glucose metabolism and insulin resistance (fasting and during oGTT).; Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).
Safety and efficacy of renal denervation	Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months	Effect on blood pressure including office, ABPM, and home-based measurements.; Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure).; Changes of antihypertensive medications.; Effects on renal function assessed with glomerular filtration rate.; Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.

Trial Locations

Locations (1)

University Hospital Saarland; 🇩🇪 Homburg/Saar, Germany