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OpenTrials
Completed

NCT Number: NCT02060110

MADIT-CRT LONG-TERM INTERNATIONAL FOLLOW-UP REGISTRY - EUROPE

The registry is designed to determine the long-term mortality and morbidity 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 Europe through five years of participation from their orginal enrollment in the MADIT-CRT IDE study.

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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

Israeli Association for Cardiovascular Trials at Sheba Medical Center

Ramat Gan, Israel

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 within Europe

Exclusion criteria

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

Treatment and study plan

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

Device

Other names: Boston Scientific market approved cardiac resynchronization therapy defibrillators

MADIT-CRT ICD ONLY ARM

Device

Other names: Market approved Boston Scientific implantable cardioverter defibrillators

Primary outcomes

  1. All-cause mortality

    Time frame: 36 month follow-up

Secondary outcomes

  1. Heart failure event or death

    Time frame: 36 month follow-up

    The combined end point of heart-failure or death, whichever came first.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • Israeli Association for Cardiovascular Trials - IACT

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Feb 11, 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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