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

Sponsor

University Hospital, Saarland (Other)

Overall Status

Unknown status

CT.gov ID

NCT01888315

Collaborator

(none)

1,000

Enrollment

Location

Arms

120

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Heart Failure Chronic Kidney Disease Diabetes Heart Rhythm Disorders	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	Phase 1/Phase 2

Detailed Description

Inclusion Criteria

Individual is 18 years of age.
Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy Study Investigating the Effects of Catheter-based Renal Denervation on Different Organ Systems in Patients With Increased Sympathetic Activity

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Catheter-based renal denervation 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	Device: Renal denervation with Symplicity Flex Medtronic/Ardian Renal denervation using CE-marked devices will be performed according to best medical practice. Device: Renal denervation with EnligHTN St. Jude Medical Renal denervation using CE-marked devices will be performed according to best medical practice. Device: Renal denervation with Paradise Recor Renal denervation using CE-marked devices will be performed according to best medical practice. Device: Renal denervation with V2 Vessix Renal denervation using CE-marked devices will be performed according to best medical practice.
No Intervention: Medical therapy Best medical therapy using guideline recommended drugs in each disease state.

Arm

Intervention/Treatment

Experimental: Catheter-based renal denervation

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

Device: Renal denervation with Symplicity Flex Medtronic/Ardian

Renal denervation using CE-marked devices will be performed according to best medical practice.

Device: Renal denervation with EnligHTN St. Jude Medical

Renal denervation using CE-marked devices will be performed according to best medical practice.

Device: Renal denervation with Paradise Recor

Renal denervation using CE-marked devices will be performed according to best medical practice.

Device: Renal denervation with V2 Vessix

Renal denervation using CE-marked devices will be performed according to best medical practice.

No Intervention: Medical therapy

Best medical therapy using guideline recommended drugs in each disease state.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Individual is 18 years of age.
Individual agrees to have all procedures performed, and is competent and willing to provide written, informed consent to participate in the registry.
Patient scheduled for renal sympathetic denervation using market-released device.

Exclusion Criteria

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.
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.).