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

This study has been terminated.
(Insufficient enrollment)
Sponsor:
Collaborator:
Medtronic
Information provided by:
Stereotaxis
ClinicalTrials.gov Identifier:
NCT00370526
First received: August 29, 2006
Last updated: January 2, 2008
Last verified: January 2008
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
Procedure: Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation

Resource links provided by NLM:


Further study details as provided by Stereotaxis:

Primary Outcome Measures:
  • Reduction in end systolic volume (ESV) [ Time Frame: 6 months ]

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

Estimated Enrollment: 100
Study Start Date: February 2007
Study Completion Date: December 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00370526

Locations
United States, Georgia
Northeast Georgia Heart Center, PC
Gainesville, Georgia, United States, 30501
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Medical College of Virginia - Virginia Commonwealth University
Richmond, Virginia, United States, 23129
Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Italy
San Raffaele University Hospital
Milan, Italy, 20132
Sponsors and Collaborators
Stereotaxis
Medtronic
Investigators
Principal Investigator: Carlo Pappone, MD, PhD San Raffaele University Hospital
  More Information

No publications provided

Responsible Party: Mark Jacob, Senrior Manager of Clinical Affairs, Stereotaxis, Inc.
ClinicalTrials.gov Identifier: NCT00370526     History of Changes
Other Study ID Numbers: PM-CLIN 008
Study First Received: August 29, 2006
Last Updated: January 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Stereotaxis:
heart failure
resynchronization
CRT
Bi-V pacemaker
LV lead placement
hemodynamic assessment
CRT Outcomes

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014