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

University Hospital, Saarland

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Chronic Kidney Disease; Hypertension; Diabetes; Heart Rhythm Disorders; Heart Failure

Treatments: Device: Renal denervation with Paradise Recor; Device: Renal denervation with V2 Vessix; Device: Renal denervation with EnligHTN St. Jude Medical; Device: Renal denervation with Symplicity Flex Medtronic/Ardian

Study type: Interventional

Funder types: Other

Identifiers

NCT01888315

Symplicity Extension

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Catheter-based renal denervation

Experimental group

Description:

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

Treatment:

Device: Renal denervation with EnligHTN St. Jude Medical

Device: Renal denervation with Symplicity Flex Medtronic/Ardian

Device: Renal denervation with V2 Vessix

Device: Renal denervation with Paradise Recor

Medical therapy

No Intervention group

Description:

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