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OpenTrials
Completed

NCT Number: NCT01294449

Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy Post Approval Registry

MADIT-CRT PAR is an FDA mandated follow-up registry for patients that participated in the MADIT-CRT IDE study examining long-term mortality.

(MADIT-CRT IDE: NCT00180271)

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester /Strong Memorial

Rochester, New York, 14642, United States

About this study

The registry is designed to determine the long-term mortality benefit as a result of Cardiac Resynchronization Therapy with Defibrillation (CRT-D) vs. Implantable Cardioverter Defibrillator (ICD) therapy in the MADIT-CRT study patient population. The registry will collect data on patients that previously participated at MADIT-CRT sites within the US through five years of participation from their orginal enrollment in the MADIT-CRT IDE study (MADIT-CRT IDE: NCT00180271).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active patients who were enrolled in the MADIT-CRT IDE (NCT00180271)within the United States

Exclusion criteria

  • Patients who are unable or unwilling to comply with the protocol requirements

Treatment and study plan

MADIT-CRT ICD

Device

Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.

Other names: Market approved Boston Scientific implantable cardioverter defibrillators

MADIT-CRT CRT-D

Device

Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.

Other names: Boston Scientific market approved cardiac resynchronization therapy defibrillators

Primary outcomes

  1. All-Cause Mortality

    Time frame: 5 years

    Outcome measured for total population. Not broken down by indication received.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: MADIT-CRT PAR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 11, 2011
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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