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

Hypertension Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01888315
Study type Interventional
Source University Hospital, Saarland
Contact Felix Mahfoud, MD
Phone +4968411621346
Email felix.mahfoud@uks.eu
Status Recruiting
Phase Phase 1/Phase 2
Start date January 2011
Completion date January 2021
View Details
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