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

  • STATUS
    Recruiting
  • participants needed
    1000
  • sponsor
    University Hospital, Saarland
Updated on 8 November 2020
hypertension

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.

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.).

Details
Condition chronic renal insufficiency, NIDDM, Diabetes Mellitus, Chronic renal failure, Heart failure, Hypertension, Heart Rhythm Disorders
Treatment Renal denervation with Symplicity Flex Medtronic/Ardian, Renal denervation with EnligHTN St. Jude Medical, Renal denervation with Paradise Recor, Renal denervation with V2 Vessix
Clinical Study IdentifierNCT01888315
SponsorUniversity Hospital, Saarland
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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.)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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