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MADIT ASIA Cardiac Resynchronization Trial

NCT01872234 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2014-04-30

No results posted yet for this study

Summary

The purpose of this trial or study is to determine if pacemaker therapy can be a beneficial alternative to conventional medical therapy in patients with a history of moderate heart failure. The investigators are looking to enroll approximately 180 people in this trial. Patients will be randomized in two groups. One group will be implanted with a pacemaker and will continue to receive conventional medical therapy as prescribed by their doctor. The second group will continue to receive conventional medical therapy as prescribed by their doctor and will not be implanted with a pacemaker. Clinical histories, physical exams, and external device testing will be collected both at the time of enrollment in the trial and during follow-up study visits. Patients who enter the study will be seen for study visits at 1 month, 3 and 6 months.

Conditions

  • Congestive Heart Failure
  • Left Bundle Branch Block
  • Heart Failure, Systolic

Interventions

DEVICE

Two-lead CRT-P

The two lead CRT-P will consist of a dual chamber pacemaker, a right atrial lead and a left ventricular lead.

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Arthur J. Moss, M.D. · Univ. of Rochester Medical Center, Rochester, New York 14642, [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • China
  • India
  • Japan
  • Malaysia
  • Singapore
  • South Korea
  • Taiwan
  • Thailand

Study Locations

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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 NCT01872234 on ClinicalTrials.gov