PROSPECT: Predictors of Response to Cardiac Re-Synchronization Therapy
NCT ID: NCT00253357
Last Updated: 2007-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
450 participants
OBSERVATIONAL
2004-03-31
2006-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Principal Investigators
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William T Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
University of Ohio
Locations
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Several Locations, California, United States
Gainsville, Florida, United States
Atlanta, Georgia, United States
Columbus, Illinois, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Grand Rapids, Michigan, United States
Several Locations, New Jersey, United States
Several Locations, New York, United States
Winston-Salem, North Carolina, United States
Several Locations, Ohio, United States
Dolyestown, Pennsylvania, United States
Nashville, Tennessee, United States
Burlington, Vermont, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Several Locations, , Austria
Several Locations, , Belgium
Several Locations, , Denmark
Several Locations, , Finland
Several Locations, , France
Several Locations, , Germany
Several Locations, , Hong Kong
Several Locations, , Italy
Several Locations, , Netherlands
Several Locations, , Norway
Several Locations, , Spain
Several Locations, , United Kingdom
Countries
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References
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Hsing JM, Selzman KA, Leclercq C, Pires LA, McLaughlin MG, McRae SE, Peterson BJ, Zimetbaum PJ. Paced left ventricular QRS width and ECG parameters predict outcomes after cardiac resynchronization therapy: PROSPECT-ECG substudy. Circ Arrhythm Electrophysiol. 2011 Dec;4(6):851-7. doi: 10.1161/CIRCEP.111.962605. Epub 2011 Sep 28.
Chan PS, Khumri T, Chung ES, Ghio S, Reid KJ, Gerritse B, Nallamothu BK, Spertus JA. Echocardiographic dyssynchrony and health status outcomes from cardiac resynchronization therapy: insights from the PROSPECT trial. JACC Cardiovasc Imaging. 2010 May;3(5):451-60. doi: 10.1016/j.jcmg.2009.08.012.
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. doi: 10.1161/CIRCULATIONAHA.107.743120. Epub 2008 May 5.
Other Identifiers
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226
Identifier Type: -
Identifier Source: org_study_id