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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01294449
Acronym
MADIT-CRT PAR
Enrollment
394
Registered
2011-02-11
Start date
2011-03-31
Completion date
2013-11-30
Last updated
2014-12-04

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

Conditions

Heart Failure

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)

Detailed description

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).

Interventions

DEVICEMADIT-CRT ICD

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

DEVICEMADIT-CRT CRT-D

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

Sponsors

Boston Scientific Corporation
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
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 (NCT00180271)within the United States

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
All-Cause Mortality5 yearsOutcome measured for total population. Not broken down by indication received.

Countries

United States

Participant flow

Pre-assignment details

For this trial permission was received by several institutional review boards to include subjects death information for participants in the MADIT-CRT IDE (NCT00180271) who died between the end of the IDE and the start of the Registry. This includes 14 subjects, 7 from each arm.

Participants by arm

ArmCount
MADIT-CRT ICD
MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
156
MADIT-CRT CRT-D
MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
252
Total408

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath1112
Overall StudyWithdrawal by Subject13

Baseline characteristics

CharacteristicMADIT-CRT ICDMADIT-CRT CRT-DTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
79 Participants126 Participants205 Participants
Age, Categorical
Between 18 and 65 years
77 Participants126 Participants203 Participants
Conduction disorder
Left Bundle Branch Block
110 participants181 participants291 participants
Conduction disorder
Nonspecific Intraventricular Conduction
24 participants40 participants64 participants
Conduction disorder
Right Bundle Brach Block
22 participants31 participants53 participants
Left Ventricular Ejection Fraction24 percentage
STANDARD_DEVIATION 5
24 percentage
STANDARD_DEVIATION 6
24 percentage
STANDARD_DEVIATION 6
New York Heart Association (NYHA) Class
NYHA Class II - Ischemic
54 participants87 participants141 participants
New York Heart Association (NYHA) Class
NYHA Class II - Non Ischemic
81 participants129 participants210 participants
New York Heart Association (NYHA) Class
NYHA Class I - Ischemic
21 participants36 participants57 participants
QRS duration158 milliseconds
STANDARD_DEVIATION 21
159 milliseconds
STANDARD_DEVIATION 18
159 milliseconds
STANDARD_DEVIATION 19
Region of Enrollment
United States
156 participants252 participants408 participants
Sex: Female, Male
Female
36 Participants78 Participants114 Participants
Sex: Female, Male
Male
120 Participants174 Participants294 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
9 / 14916 / 245
serious
Total, serious adverse events
58 / 14993 / 245

Outcome results

Primary

All-Cause Mortality

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

Time frame: 5 years

ArmMeasureValue (NUMBER)
MADIT-CRT ICDAll-Cause Mortality11 participants
MADIT-CRT CRT-DAll-Cause Mortality12 participants
Comparison: The sample size for the analysis included subjects from the original MADIT-CRT IDE (NCT00180271) that did not participate in the Registry portion, these subjects are censored at the time of study conclusion, withdrawal or death during the IDE. This was done as the Registry is a post approval continuation of the follow-up from the MADIT-CRT IDE trial. This is not a pooled analysis from separate studies.p-value: 0.3795% CI: [0.67, 1.161]Regression, Cox
Comparison: These data represent the indicated sub population of left bundle branch block subjects only. (Left bundle branch block N= 110 ICD group: 181 CRT-D group)p-value: 0.02895% CI: [0.484, 0.96]Regression, Cox

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026