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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02060110
Enrollment
447
Registered
2014-02-11
Start date
2010-05-31
Completion date
2014-01-31
Last updated
2014-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

CRT, HEART FAILURE

Brief summary

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.

Interventions

DEVICEPatients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study
DEVICEMADIT-CRT ICD ONLY ARM

Sponsors

Israeli Association for Cardiovascular Trials - IACT
CollaboratorUNKNOWN
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
All-cause mortality36 month follow-up

Secondary

MeasureTime frameDescription
Heart failure event or death36 month follow-upThe combined end point of heart-failure or death, whichever came first.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026