Trial Outcomes & Findings for Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support (NCT NCT01932294)

NCT ID: NCT01932294

Last Updated: 2018-12-06

Results Overview

Death after the baseline visit up to 24 months

• Recruitment status: COMPLETED
• Target enrollment: 171 participants
• Primary outcome timeframe: 6 month intervals after the baseline visit up to 24 months
• Results posted on: 2018-12-06

Participant Flow

Participant milestones

Measure	MedaMACS Participants All participants who have met the inclusion criteria.
Overall Study STARTED	171
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	99

Reasons for withdrawal

Measure	MedaMACS Participants All participants who have met the inclusion criteria.
Overall Study Death	43
Overall Study Lost to Follow-up	8
Overall Study VAD Implantation	20
Overall Study Heart Transplantation	16
Overall Study Transferred to other hospitals	12

Baseline Characteristics

1 participant missed this variable

Baseline characteristics by cohort

Measure	MedaMACS Participants n=171 Participants All participants who have met the inclusion criteria.
Age, Categorical <=18 years	0 Participants n=170 Participants • 1 participant missed this variable
Age, Categorical Between 18 and 65 years	53 Participants n=170 Participants • 1 participant missed this variable
Age, Categorical >=65 years	117 Participants n=170 Participants • 1 participant missed this variable
Age, Continuous	59.03 years STANDARD_DEVIATION 10.95 • n=171 Participants
Sex: Female, Male Female	57 Participants n=170 Participants • One participant missing a value for the variable
Sex: Female, Male Male	113 Participants n=170 Participants • One participant missing a value for the variable
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=171 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	160 Participants n=171 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=171 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=171 Participants
Race (NIH/OMB) Asian	0 Participants n=171 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=171 Participants
Race (NIH/OMB) Black or African American	47 Participants n=171 Participants
Race (NIH/OMB) White	119 Participants n=171 Participants
Race (NIH/OMB) More than one race	0 Participants n=171 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=171 Participants
Region of Enrollment United States	171 participants n=171 Participants

PRIMARY outcome

Timeframe: 6 month intervals after the baseline visit up to 24 months

Population: By the end of the follow-up, 43 patients had deceased.

Death after the baseline visit up to 24 months

Outcome measures

Measure	MedaMACS Participants n=171 Participants All participants who have met the inclusion criteria. By the end of the follow-up, 43 out of 171 patients died.
Number of Heart Failure Participants Deceased at 24 Months	43 Participants

SECONDARY outcome

Timeframe: 6 month intervals after the baseline visit up to 24 months

Population: Patients with known endpoints.

Known VAD implantation after the baseline visit up to 24 months

Outcome measures

Measure	MedaMACS Participants n=171 Participants All participants who have met the inclusion criteria. By the end of the follow-up, 43 out of 171 patients died.
Number of Participants With Known Ventricular Assist Device (VAD) Implantation	20 Participants

SECONDARY outcome

Timeframe: 6 month intervals after the baseline visit up to 24 months

Population: Patients with known endpoints.

Heart transplantation after the baseline visit up to 24 months

Outcome measures

Measure	MedaMACS Participants n=171 Participants All participants who have met the inclusion criteria. By the end of the follow-up, 43 out of 171 patients died.
Number of Participants With Known Heart Transplantation	16 Participants

Adverse Events

MedaMACS Participants

Serious events: 93 serious events

Other events: 12 other events

Deaths: 43 deaths

Serious adverse events

Measure	MedaMACS Participants n=171 participants at risk All participants who have met the inclusion criteria.
Investigations Rehospitalization	54.4% 93/171 • Number of events 273 • After the baseline visit and up to 24 months
Cardiac disorders IV Inotropes Dependent at 6 months	7.0% 12/171 • After the baseline visit and up to 24 months

Other adverse events

Measure	MedaMACS Participants n=171 participants at risk All participants who have met the inclusion criteria.
Infections and infestations All-location Infection	7.0% 12/171 • Number of events 19 • After the baseline visit and up to 24 months

Additional Information

RongBing Xie

University of Alabama at Birmingham

Phone: 205-975-3624

Email: rongbingxie@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place