PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy - Full Text View

Sponsors and Collaborators:	Medtronic Cardiac Rhythm Disease Management Medtronic
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00253357

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

MedlinePlus related topics: Cardiomyopathy Heart Failure

U.S. FDA Resources

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

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

Publications indexed to this study:

Chung ES, Leon AR, Tavazzi L, Sun JP, Nihoyannopoulos P, Merlino J, Abraham WT, Ghio S, Leclercq C, Bax JJ, Yu CM, Gorcsan J 3rd, St John Sutton M, De Sutter J, Murillo J. Results of the Predictors of Response to CRT (PROSPECT) trial. Circulation. 2008 May 20;117(20):2608-16. Epub 2008 May 5.

Study ID Numbers:	226
Study First Received:	November 13, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00253357
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

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Cardiomyopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009