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PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy

This study has been completed.
Information provided by:
Medtronic Cardiac Rhythm and Heart Failure Identifier:
First received: November 13, 2005
Last updated: December 17, 2007
Last verified: December 2007
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.

Heart Failure
Congestive Heart Failure

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

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

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
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 identifier: NCT00253357

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00253357     History of Changes
Other Study ID Numbers: 226
Study First Received: November 13, 2005
Last Updated: December 17, 2007

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 26, 2017