HEAL-HF: A Cardiac Resynchronization Therapy (CRT) Outcomes Study

January 2, 2008 updated by: Stereotaxis

HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation

The literature shows that approximately 40% of individuals who receive a cardiac resynchronization therapy (CRT) device for symptomatic congestive heart failure (CHF) do not have a clinical benefit from the device. The HEAL-HF protocol will compare the outcomes of conventionally placed CRT devices with magnetically placed CRT devices by assessing hemodynamic parameters during the magnetic placement of the left ventricular (LV) lead.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Baseline information will be obtained including QoL, 6-minute walk, and echo measurements. The patient will be randomized to receive a conventionally-placed LV lead or randomized to receive a magnetically-placed LV lead. The magnetic group will have acute hemodynamics assessed during the procedure to evaluate the best response of the left ventricle during pacing. Patients will be followed for 6 months with a re-evaluation of the baseline tests to assess the change in HF symptoms. Adverse events will also be recorded during the follow-up period.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
  • Italy
      • Milan, Italy, 20132
        • San Raffaele University Hospital
  • United States
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Heart Center, PC
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Virginia
      • Richmond, Virginia, United States, 23129
        • Medical College of Virginia - Virginia Commonwealth University

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ischemic cardiomyopathy
  • Ejection Fraction (EF) <= 35%
  • QRS duration >= 120 msec
  • Standard heart failure (HF) oral medications for at least 1 month
  • Evidence of mechanical dyssynchrony
  • NYHA Class III or IV

Exclusion Criteria:

  • Persistent or chronic atrial fibrillation (AF)
  • Hemodynamically unstable or uncontrolled arrhythmias
  • Unstable angina
  • Aortic valve (AV) insufficiency or stenosis
  • Mitral valve (MV) regurgitation > 2+
  • Active infection
  • Contraindications for heparin
  • Dependence on atrial pacing

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in end systolic volume (ESV)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
New York Heart Association (NYHA) Class
Time Frame: 6 months
6 months
6 minute walk
Time Frame: 6 months
6 months
Quality of life (QoL)
Time Frame: 6 months
6 months
Cardiac-related mortality
Time Frame: 6 months
6 months
HF-related hospitalizations
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Stereotaxis

Collaborators

Medtronic

Investigators

  • Principal Investigator: Carlo Pappone, MD, PhD, San Raffaele University Hospital

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

February 1, 2007

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 29, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

August 31, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2008

Last Update Submitted That Met QC Criteria

January 2, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM-CLIN 008

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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