Brief Summary

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)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

394

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

February 7, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed

18 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 4, 2014

Completed

Last Updated

December 4, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

February 7, 2011

Results QC Date

August 25, 2014

Last Update Submit

December 3, 2014

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

All-Cause Mortality
Outcome measured for total population. Not broken down by indication received.
5 years

Study Arms (2)

MADIT-CRT ICD

Device: MADIT-CRT ICD

MADIT-CRT CRT-D

Device: MADIT-CRT CRT-D

Interventions

MADIT-CRT ICDDEVICE

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

Also known as: Market approved Boston Scientific implantable cardioverter defibrillators

MADIT-CRT ICD

MADIT-CRT CRT-DDEVICE

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

Also known as: Boston Scientific market approved cardiac resynchronization therapy defibrillators

MADIT-CRT CRT-D

Eligibility Criteria

Age21 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

The registry involves only those patients that participated in the MADIT-CRT IDE study within the United States.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boston Scientific Corporationlead

Study Sites (1)

University of Rochester /Strong Memorial

Rochester, New York, 14642, United States

Location

Related Publications (8)

Vidula H, Lee E, McNitt S, Polonsky B, Aktas M, Rosero S, Younis A, Solomon SD, Zareba W, Kutyifa V, Goldenberg I. Cardiac Resynchronization Therapy and Risk of Recurrent Hospitalizations in Patients Without Left Bundle Branch Block: The Long-Term Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy. Circ Heart Fail. 2020 Jul;13(7):e006925. doi: 10.1161/CIRCHEARTFAILURE.120.006925. Epub 2020 Jul 1.
PMID: 32605387DERIVED
Kutyifa V, Vermilye K, Solomon SD, McNitt S, Moss AJ, Daimee UA. Long-term outcomes of cardiac resynchronization therapy by left ventricular ejection fraction. Eur J Heart Fail. 2019 Mar;21(3):360-369. doi: 10.1002/ejhf.1357. Epub 2018 Dec 28.
PMID: 30592353DERIVED
Biton Y, Kutyifa V, Cygankiewicz I, Goldenberg I, Klein H, McNitt S, Polonsky B, Ruwald AC, Ruwald MH, Moss AJ, Zareba W. Relation of QRS Duration to Clinical Benefit of Cardiac Resynchronization Therapy in Mild Heart Failure Patients Without Left Bundle Branch Block: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Substudy. Circ Heart Fail. 2016 Feb;9(2):e002667. doi: 10.1161/CIRCHEARTFAILURE.115.002667.
PMID: 26823498DERIVED
Biton Y, Zareba W, Goldenberg I, Klein H, McNitt S, Polonsky B, Moss AJ, Kutyifa V; MADIT-CRT Executive Committee. Sex Differences in Long-Term Outcomes With Cardiac Resynchronization Therapy in Mild Heart Failure Patients With Left Bundle Branch Block. J Am Heart Assoc. 2015 Jun 29;4(7):e002013. doi: 10.1161/JAHA.115.002013.
PMID: 26124205DERIVED
Daimee UA, Moss AJ, Biton Y, Solomon SD, Klein HU, McNitt S, Polonsky B, Zareba W, Goldenberg I, Kutyifa V. Long-Term Outcomes With Cardiac Resynchronization Therapy in Patients With Mild Heart Failure With Moderate Renal Dysfunction. Circ Heart Fail. 2015 Jul;8(4):725-32. doi: 10.1161/CIRCHEARTFAILURE.115.002082. Epub 2015 Jun 2.
PMID: 26038537DERIVED
Goldenberg I, Kutyifa V, Klein HU, Cannom DS, Brown MW, Dan A, Daubert JP, Estes NA 3rd, Foster E, Greenberg H, Kautzner J, Klempfner R, Kuniss M, Merkely B, Pfeffer MA, Quesada A, Viskin S, McNitt S, Polonsky B, Ghanem A, Solomon SD, Wilber D, Zareba W, Moss AJ. Survival with cardiac-resynchronization therapy in mild heart failure. N Engl J Med. 2014 May 1;370(18):1694-701. doi: 10.1056/NEJMoa1401426. Epub 2014 Mar 30.
PMID: 24678999DERIVED
Skali H, Dwyer EM, Goldstein R, Haigney M, Krone R, Kukin M, Lichstein E, McNitt S, Moss AJ, Pfeffer MA, Solomon SD. Prognosis and response to therapy of first inpatient and outpatient heart failure event in a heart failure clinical trial: MADIT-CRT. Eur J Heart Fail. 2014 May;16(5):560-5. doi: 10.1002/ejhf.71. Epub 2014 Feb 27.
PMID: 24578164DERIVED
Campbell P, Takeuchi M, Bourgoun M, Shah A, Foster E, Brown MW, Goldenberg I, Huang DT, McNitt S, Hall WJ, Moss A, Pfeffer MA, Solomon SD; Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy (MADIT-CRT) Investigators. Right ventricular function, pulmonary pressure estimation, and clinical outcomes in cardiac resynchronization therapy. Circ Heart Fail. 2013 May;6(3):435-42. doi: 10.1161/CIRCHEARTFAILURE.112.000127. Epub 2013 Mar 22.
PMID: 23524528DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title: Dr. Arthur Moss
Organization: University of Rochester Heart Research Follow-up Program

Study Officials

Arthur J Moss, MD
University of Rochester Heart Research Follow-up Program
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 11, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

December 4, 2014

Results First Posted

December 4, 2014

Record last verified: 2014-03

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

MADIT-CRT ICD

MADIT-CRT CRT-D

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations