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PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00253357
First Posted: November 15, 2005
Last Update Posted: December 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure
  Purpose
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. Using a medical device like a pacemaker or a defibrillator can help the heart to pump in regular beats. However, not all patients do better with a device. Currently, there is not a way to identify which patients will benefit from the device. The purpose of this study is to determine if using medical tests, Echocardiogram, can help in predicting which patients will improve. The types of patients needed for this study are those who have been diagnosed with moderate or severe heart failure.

Condition
Heart Failure Congestive Heart Failure Cardiomyopathy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predictors of Response to Cardiac Re-Synchronization Therapy

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Estimated Enrollment: 450
Study Start Date: March 2004
Study Completion Date: June 2006
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe heart failure

    • Ejection Fraction ( measurement of blood pumped out of the heart) less than 35%
    • Wide (greater than 130 milliseconds) QRS duration for US patients only.
    • May include patients with less than 130 millisecond QRS duration if they have mechanical dyssynochrony (uncoordinated heart contractions) in Europe.
    • All patients enrolled should be stable on medications that include at least an ACE inhibitor or Angiotensin Receptor Blocker (ARB) and at optimal level for at least one month prior to surgery

Exclusion Criteria:

  • Patients that are not eligible for this study are those that have a mechanical right heart valve or are experiencing the following medical conditions within the last 3 months:

    • Chest pain / unstable angina
    • Acute heart attack
    • Chronic or permanent atrial arrhythmias such as atrial fibrillation
    • Contrary artery bypass graft (CABG)
    • Percutaneous transluminal coronary angioplasty (PTCA)
    • Patients who have had intermittent or continuous Inotropic drug therapy are not eligible for this study.
    • Patients who have had heart transplant or a prior Cardiac Resynchronization Therapy device are not eligible for this study.
    • Patients who are pregnant or are of child-bearing potential are not on a form of birth control may not participate in this study.
  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): NCT00253357


  Show 28 Study Locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Medtronic
Investigators
Principal Investigator: William T Abraham, MD University of Ohio
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00253357     History of Changes
Other Study ID Numbers: 226
First Submitted: November 13, 2005
First Posted: November 15, 2005
Last Update Posted: December 21, 2007
Last Verified: December 2007

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Heart Failure
Congestive Heart Failure
Fluid overload
Left sided heart failure
Pacemaker
Defibrillator

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases