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

U

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

  • 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.).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

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.

Trial contacts and locations

1

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Central trial contact

Michael Böhm, MD; Felix Mahfoud, MD

Data sourced from clinicaltrials.gov

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