NCT01290822|TerminatedPhase 1/2Results
Study Stopped
Slow accrual and anticipated loss of funding
Optimized Biventricular Pacing Allograft Recipients
BiBET
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Slow accrual and anticipated loss of funding
BiBET
Sponsor study identifier
Secondary identifiers
interventional
12
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2011
Actual (reported)Study Completion
March 2011
Actual (reported)This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. It examines the effects of atrioventricular delay (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an identical heart rate.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
February 2, 2011
Actual (reported)February 7, 2011
Actual (reported)March 2011
Actual (reported)March 2011
Actual (reported)August 15, 2016
Actual (reported)Cardiac Output
The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.
13 minutes of testing; performed before CPB for allograft receipt
Atrial Latency
13 minutes of testing; performed before CPB for allograft receipt
Interatrial Delay (Between Right Atrium and Left Atrium)
13 minutes of testing; performed before CPB for allograft receipt
BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output.
Traditional atrial (AAI) pacing
Biventricular pacing
Atrial pacing
Columbia University Medial Center
New York, New York, 10032, United States
Henry M Spotnitz, MD
Columbia University
12 participants (actual enrollment reported by the registry).
First Submitted
February 2, 2011
First Posted
February 7, 2011
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Peak LV dP/dt
13 minutes of testing; performed before CPB for allograft receipt
Peak RV dP/dt
13 minutes of testing; performed before CPB for allograft receipt
Interventricular Synchrony
13 minutes of testing; performed before CPB for allograft receipt
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 2011
Actual (reported)Study Completion
March 2011
Actual (reported)Last Updated
October 6, 2016
Results First Posted
August 15, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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