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Optimized Biventricular Pacing Allograft Recipients (BiBET)

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ClinicalTrials.gov Identifier: NCT01290822
Recruitment Status : Terminated (Slow accrual and anticipated loss of funding)
First Posted : February 7, 2011
Results First Posted : August 15, 2016
Last Update Posted : October 6, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Henry M. Spotnitz, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Dilated Cardiomyopathy
Ischemic Cardiomyopathy
Interventions Device: BiVP
Device: AAI Pacing
Enrollment 12
Recruitment Details 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 It is also not available for the rest of the subjects as they were withdrawn before being studied.
Pre-assignment Details  
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description 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 It is also not available for the rest of the subjects as they were withdrawn before being studied.
Period Title: Overall Study
Started 12
Completed 1
Not Completed 11
Reason Not Completed
Withdrawal by Subject             1
Physician Decision             10
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description 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 It is also not available for the rest of the subjects as they were withdrawn before being studied.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 Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  66.7%
>=65 years
4
  33.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
2
  16.7%
Male
10
  83.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  41.7%
White
6
  50.0%
More than one race
1
   8.3%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Cardiac Output
Hide Description The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.
Time Frame 13 minutes of testing; performed before CPB for allograft receipt
Hide Outcome Measure Data
Hide Analysis Population Description
Results could not be analyzed due to poor enrollment and lack of data.
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description:
This includes all subjects in the study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Atrial Latency
Hide Description [Not Specified]
Time Frame 13 minutes of testing; performed before CPB for allograft receipt
Hide Outcome Measure Data
Hide Analysis Population Description
Results could not be analyzed due to poor enrollment and lack of data.
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description:
This includes all subjects in the study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Interatrial Delay (Between Right Atrium and Left Atrium)
Hide Description Results could not be analyzed due to poor enrollment and lack of data.
Time Frame 13 minutes of testing; performed before CPB for allograft receipt
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description:
This includes all subjects in the study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Peak LV dP/dt
Hide Description [Not Specified]
Time Frame 13 minutes of testing; performed before CPB for allograft receipt
Hide Outcome Measure Data
Hide Analysis Population Description
Results could not be analyzed due to poor enrollment and lack of data.
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description:
This includes all subjects in the study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Peak RV dP/dt
Hide Description [Not Specified]
Time Frame 13 minutes of testing; performed before CPB for allograft receipt
Hide Outcome Measure Data
Hide Analysis Population Description
Results could not be analyzed due to poor enrollment and lack of data.
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description:
This includes all subjects in the study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Interventricular Synchrony
Hide Description [Not Specified]
Time Frame 13 minutes of testing; performed before CPB for allograft receipt
Hide Outcome Measure Data
Hide Analysis Population Description
Results could not be analyzed due to poor enrollment and lack of data.
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description:
This includes all subjects in the study
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events are not available due to poor enrollment and lack of data.
 
Arm/Group Title All Subjects in the Study
Hide Arm/Group Description This includes all subjects in the study
All-Cause Mortality
All Subjects in the Study
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Subjects in the Study
Affected / at Risk (%)
Total   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Subjects in the Study
Affected / at Risk (%)
Total   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Henry M. Spotnitz, MD
Organization: Columbia University
Phone: (212) 305-6191
EMail: hms2@columbia.edu
Layout table for additonal information
Responsible Party: Henry M. Spotnitz, Columbia University
ClinicalTrials.gov Identifier: NCT01290822     History of Changes
Other Study ID Numbers: AAAC1492
1R01HL080152-01A2 ( U.S. NIH Grant/Contract )
First Submitted: February 2, 2011
First Posted: February 7, 2011
Results First Submitted: May 26, 2016
Results First Posted: August 15, 2016
Last Update Posted: October 6, 2016