NCT01290822

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

August 15, 2016

Completed
Last Updated

October 6, 2016

Status Verified

August 1, 2016

Enrollment Period

4.2 years

First QC Date

February 2, 2011

Results QC Date

May 26, 2016

Last Update Submit

August 25, 2016

Conditions

Dilated CardiomyopathyIschemic Cardiomyopathy

Keywords

Biventricular pacingDilated CardiomyopathyIschemic CardiomyopathyCongestive heart failureCardiac allograftCardiac surgeryAVDVVDLV pacing sitepacing optimization

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (2)

BiVP Pacing

EXPERIMENTAL

BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output.

Device: BiVP

AAI Pacing

ACTIVE COMPARATOR

Traditional atrial (AAI) pacing

Device: AAI Pacing

Interventions

BiVPDEVICE

Biventricular pacing

Also known as: Biventricular Pacing
BiVP Pacing
AAI PacingDEVICE

Atrial pacing

Also known as: Atrial Pacing
AAI Pacing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • New York Heart Association (NYHA) heart failure class III/IV
  • Left Ventricular Ejection Fraction (LVEF) \<36%
  • QRS \>120 msec

You may not qualify if:

  • Intracardiac shunts
  • Sinus tachycardia \>120 bpm
  • Second or third degree heart block
  • Previous cardiac surgery
  • Mechanical circulatory assistance
  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medial Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, DilatedHeart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Results Point of Contact

Title
Henry M. Spotnitz, MD
Organization
Columbia University
hms2@columbia.edu
(212) 305-6191

Study Officials

  • Henry M Spotnitz, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
George H. Humphreys, II Professor of Surgery

Study Record Dates

First Submitted

February 2, 2011

First Posted

February 7, 2011

Study Start

January 1, 2007

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

October 6, 2016

Results First Posted

August 15, 2016

Record last verified: 2016-08

Locations

US(1)