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

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ClinicalTrials.gov Identifier: NCT00370526
Recruitment Status : Terminated (Insufficient enrollment)
First Posted : August 31, 2006
Last Update Posted : January 11, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure, Congestive Procedure: Acute hemodynamic assessment using PV Loops (CD Leycom, The Netherlands) during LV lead placement Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HEmodynamic Assessment of Optimal Left Heart Lead Placement for Heart Failure Enabled by Magnetic Navigation
Study Start Date : February 2007
Primary Completion Date : April 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. New York Heart Association (NYHA) Class [ Time Frame: 6 months ]
  2. 6 minute walk [ Time Frame: 6 months ]
  3. Quality of life (QoL) [ Time Frame: 6 months ]
  4. Cardiac-related mortality [ Time Frame: 6 months ]
  5. HF-related hospitalizations [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 31, 2006    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: January 2008

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