NCT01392196

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3.7 years

First QC Date

July 7, 2011

Last Update Submit

January 30, 2017

Conditions

Heart Failure

Keywords

Renal Impairment

Outcome Measures

Primary Outcomes (1)

  • Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events

    6 month

Secondary Outcomes (2)

  • Ventricular function as measured by Echocardiography

    6 month

  • Renal function as measured by Glomerular Filtration Rate (GFR)

    6 months

Study Arms (1)

Single arm

OTHER

Renal Denervation

Procedure: Renal Denervation

Interventions

Renal DenervationPROCEDURE

Renal Denervation using the Symplicity Catheter in Heart Failure Population

Single arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Heart FailureRenal Insufficiency

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Henry Krum, MD

    The Alfred

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 12, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

AU(1)