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

June 24, 2013 updated by: University Hospital, Saarland

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.).

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Homburg/Saar, Germany, 66421
        • Recruiting
        • University hospital Saarland
        • Contact:
          • Michael Böhm, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Catheter-based renal denervation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and efficacy of renal denervation
Time Frame: Baseline to 6 months

Effect on blood pressure including office, ABPM, and home-based measurements.

Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure).

Changes of antihypertensive medications.

Effects on renal function assessed with glomerular filtration rate.

Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of renal denervation on different organ systems.
Time Frame: Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

Myocardial function and geometry using echo and MRI.

Heart rate changes and arrhythmias.

Glucose metabolism and insulin resistance (fasting and during oGTT).

Hospitalization rates (eg. hypertensive emergencies, heart failure, etc).
Baseline, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months
Safety and efficacy of renal denervation
Time Frame: Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

Effect on blood pressure including office, ABPM, and home-based measurements.

Number of adverse events (death, stroke, myocardial infarction, new dialysis, and congestive heart failure).

Changes of antihypertensive medications.

Effects on renal function assessed with glomerular filtration rate.

Renovascular safety (renal artery stenosis) assessed by duplex ultrasound.
Baseline, 3, 12, 18, 24, 30, 36, 42, 48, 54, 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Investigators

  • Study Director: Felix Mahfoud, MD, University Hospital, Saarland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

June 24, 2013

First Posted (ESTIMATE)

June 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 24, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Symplicity Extension

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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