Post-Myocardial Infarction Remodeling Prevention Therapy

NCT01213251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2016-12-15

Study results available
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Summary

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.

Conditions

  • Acute Myocardial Infarction
  • Pacing Therapy
  • Cardiac Remodeling
  • Heart Failure

Interventions

DEVICE

Single Site Pacing

Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.

DEVICE

Dual Site Pacing

Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Gregg Stone, MD · Columbia University

  • Angel Leon, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-10-31
Completion
2016-04-30

Countries

  • United States
  • Denmark
  • France
  • Germany
  • Hungary
  • Saudi Arabia
  • Slovakia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213251 on ClinicalTrials.gov