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PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00253357
First received: November 13, 2005
Last updated: December 17, 2007
Last verified: December 2007
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253357

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

No publications provided by Medtronic Cardiac Rhythm Disease Management

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00253357     History of Changes
Other Study ID Numbers: 226
Study First Received: November 13, 2005
Last Updated: December 17, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 13, 2013