The purpose of this study is to demonstrate the feasibility of pacing as a therapy to prevent adverse remodeling of the myocardium following an acute myocardial infarction (MI) in patients at highest risk for adverse myocardial remodeling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
129
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
Arizona Arrhythmia Consultants
Change in Left Ventricular End Diastolic Volume (LVEDV)
Left ventricular end diastolic volume (LVEDV) was measured by echocardiogram. Change was measured as Month 18 LVEDV minus baseline LVEDV. Per protocol, change in LVEDV is compared between Pooled Pacing (Single site + Dual Site) and Control.
Time frame: Baseline - 18 Month Follow Up Visit
Safety of Implanting a Cardiac Resynchronization Therapy With Defibrillator (CRT-D) Device Within 10 Days of Myocardial Infarction (MI), as Measured by the Rate of Reported Adverse Events
Survival estimates at 18 months post-implant for time to first following events: (a) System Related Adverse Event (b) System Related Complication (c) Procedure Related Adverse Event (d) Procedure Related Complication and (e) System Related or Procedure Related Complication.
Time frame: 18 months post-implant
Frequency of Hospitalization for Cardiovascular Events
Number of hospitalizations related to cardiovascular events.
Time frame: Baseline - 18 Month Follow Up Visit
Change in New York Heart Association (NYHA) Functional Class
The New York Heart Association (NYHA) score classifies patients' heart failure according to the severity of their symptoms. In particular, Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. NYHA change from baseline to 18-month visit. If a subject improved by one NYHA class or more (e.g. NYHA IV to NYHA II, or NYHA III to NYHA I, etc) from the baseline visit, the subject was classified as "Improved". Similarly for "Worsened" (e.g. subject does not have heart failure to NYHA I, NYHA I to NYHA II, etc.). If the subjects' NYHA Class is not different than baseline, then the subject was classified as "No Change". Per protocol, change in NYHA is compared between Pooled Pacing (Single site + Dual Site) and Control.
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Scottsdale, Arizona, United States
Kaiser Permanente
Los Angeles, California, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Lexington Cardiac Research Foundation
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Michigan Heart, PC
Ypsilanti, Michigan, United States
Carolina Heart Specialists
Gastonia, North Carolina, United States
Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
...and 16 more locations
Time frame: Baseline - 18 Month Follow Up Visit
Change in 6-minute Walk Test Distance
Change in 6-minute hallwalk distance from 1-month visit to the 18-month visit. Change is defined as month 18 minus baseline. Per protocol, change in 6-minute walk test distance is compared between Pooled Pacing (Single site + Dual Site) and Control.
Time frame: 1 Month - 18 Month Follow Up Visit
Change in Quality of Life
Change in the Minnesota Living with Heart Failure (MNLWHF) questionnaire from baseline to the 18-month follow-up visit. Change is defined as month 18 minus baseline. Per protocol change in MNLWHF is compared between Pooled Pacing (Dual Site + Single Site) and Control.
Time frame: Baseline - 18 Month Follow Up Visit
Incidence of Sudden Cardiac Death and Total Mortality
Mortality rates (%) for the events (a) all-cause death and (b) sudden-cardiac death at 18 months post randomization. Calculated using Kaplan-Meier methods. Per protocol the comparison of mortality rates is between Pooled Pacing (Dual Site + Single Site) and Control.
Time frame: 18 Months post-randomization
Linear Association Between Change in LVEDV and Selected Clinical Characteristics; Including Peak Creatinine Phosphokinase (CPK), Peak Troponin, Lead Location, Time From MI Onset to Implant, and Change in LV Volumes.
Linear association between change in LVEDV from baseline to 18-month visit (i.e. ΔLVEDV) and the following clinical characteristics were assessed: age, days from MI to implant, gender, hypertension, hyperlipidemia, diabetes, peak CPK, infarct location, LV electrode in acceptable place, and baseline LVEF. In order to assess these linear associations, linear regression models were fitted for each of these clinical characteristics (separately). In particular, each linear regression model had baseline LVEDV and the clinical characteristic as covariates, and ΔLVEDV was the response variable. Variables resulting in statistical significant (p\<0.05) are reported.
Time frame: Baseline - 18 Month Follow Up Visit