Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial (SymplicityHF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Medtronic Vascular
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01392196
First received: July 7, 2011
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.


Condition Intervention Phase
Heart Failure
Procedure: Renal Denervation
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Ventricular function as measured by Echocardiography [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Renal function as measured by Glomerular Filtration Rate (GFR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Renal Denervation
    Renal Denervation using the Symplicity Catheter in Heart Failure Population
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Heart Failure patients NYHA Class II or III
  • Renal Impairment Left Ventricular Ejection Function <40%
  • GFR 30 to 75 mL/min/1.73m2
  • Optimal stable medical therapy

Exclusion Criteria:

  • Renal artery anatomy must be eligible for treatment as determined by Angiography, and
  • History of prior renal artery intervention
  • Single functioning kidney.
  • Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months
  • Systolic BP < 90 mmHG
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392196

Contacts
Contact: K. Bogdanovich rs.medtroniccardiovascularclinicaltrials@medtronic.com

Locations
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia
Principal Investigator: Henry Krum, MD         
Sponsors and Collaborators
Medtronic Vascular
Investigators
Principal Investigator: Henry Krum, MD The Alfred
  More Information

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01392196     History of Changes
Other Study ID Numbers: TP085
Study First Received: July 7, 2011
Last Updated: July 8, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: Ministry of Health
Sweden: Medical Products Agency
Austria: Austrian Medicines and Medical Devices Agency

Keywords provided by Medtronic Vascular:
Renal Impairment

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014