NCT01888315

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University Hospital, Saarland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.).

Conditions

• Hypertension
• Heart Failure
• Chronic Kidney Disease
• Diabetes
• Heart Rhythm Disorders

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-01-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2013-06-27
• Last updated: 2013-06-27

Locations

1 site across 1 country: Germany