Trial Outcomes & Findings for Optimized Biventricular Pacing Allograft Recipients (NCT NCT01290822)

NCT ID: NCT01290822

Last Updated: 2016-10-06

Results Overview

The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 13 minutes of testing; performed before CPB for allograft receipt
• Results posted on: 2016-10-06

Participant Flow

Data could not be analyzed due to poor enrollment and lack of data. "Per Arm" information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied.

Participant milestones

Measure	All Subjects in the Study This includes all subjects in the study. "Per Arm" information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied.
Overall Study STARTED	12
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	All Subjects in the Study This includes all subjects in the study. "Per Arm" information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	10

Baseline Characteristics

Optimized Biventricular Pacing Allograft Recipients

Baseline characteristics by cohort

Measure	All Subjects in the Study n=12 Participants This includes all subjects in the study. "Per Arm" information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 13 minutes of testing; performed before CPB for allograft receipt

Population: Results could not be analyzed due to poor enrollment and lack of data.

The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 minutes of testing; performed before CPB for allograft receipt

Population: Results could not be analyzed due to poor enrollment and lack of data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 minutes of testing; performed before CPB for allograft receipt

Results could not be analyzed due to poor enrollment and lack of data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 minutes of testing; performed before CPB for allograft receipt

Population: Results could not be analyzed due to poor enrollment and lack of data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 minutes of testing; performed before CPB for allograft receipt

Population: Results could not be analyzed due to poor enrollment and lack of data.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 minutes of testing; performed before CPB for allograft receipt

Population: Results could not be analyzed due to poor enrollment and lack of data.

Outcome measures

Outcome data not reported

Adverse Events

All Subjects in the Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Henry M. Spotnitz, MD

Columbia University

Phone: (212) 305-6191

Email: hms2@columbia.edu

Results disclosure agreements

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