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A Pilot Study Comparing the Programmed Delay Between the Atrial and Ventricle Interval (BRAVO-CRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00794183
Recruitment Status : Terminated (funding difficulty)
First Posted : November 19, 2008
Last Update Posted : June 26, 2012
Sponsor:
Collaborator:
Minnesota Medical Foundation
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE November 18, 2008
First Posted Date  ICMJE November 19, 2008
Last Update Posted Date June 26, 2012
Study Start Date  ICMJE June 2004
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
To assess the effect of CRT atrioventricular delay settings on biochemical markers in blood through 6 months [ Time Frame: end of the study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00794183 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
  • assess effects of echocardiogram through 6months after CRT on heart failure [ Time Frame: end to study ]
  • assess the effects of minnesota Living with heart failure questionaire through 6 months after CRT on heart failure [ Time Frame: end of study ]
  • assess effects of six minute hall walk through 6 months after CRt on heart failure [ Time Frame: end of study ]
  • assess effects of SDANN through 6 months after CRT on heart failure [ Time Frame: end of study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study Comparing the Programmed Delay Between the Atrial and Ventricle Interval
Official Title  ICMJE A Pilot Study of theRelationship Between Atrio-Ventricular Delay and Changes in Biochemical Markers of Chronic Heart Failure During Cardiac Resynchronization Therapy (BRAVO-CRT)
Brief Summary

The idea of this study is to compare different ways of setting up a pacemaker, using blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient.

The setting we propose to adjust is the timing between the impulse sent between top and bottom chambers.

Detailed Description

There are different kinds of pacemakers and different ways they can be set up to try to make the heart beat regularly. A normal heart has four chambers; these four chambers pump in a co-ordinated way to move blood effectively. When pacemakers were first invented, they told the heart when to pump, but didn't make the four chambers work well together. Newer pacemakers can give more detailed instructions, so the chambers work together more effectively. We already know that the newer (bi-ventricular) pacemakers work better for some patients with heart failure.

There are blood tests (often referred to as "markers") that give us information about how well your heart is working and about how your body is responding to heart failure. The idea of this study is to compare different ways of setting up a pacemaker, using these blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient.

Usually pacemakers have two wires or leads, one is in the top right chamber and the other in the bottom right chamber of the heart. The newer pacemakers, which are given to patients with heart failure, have an additional lead or wire, which goes to the left side of the heart. So when heart contracts the lead from top chamber sends impulses to bottom chambers and the leads in right and left sides of bottom chamber responds by sending impulses in a co-ordinated way enabling heart to contract efficiently.

Currently, the standard way of treating patients with heart failure is by pacing the top and then bottom chambers, based on a timing interval determined by ultrasound, while also pacing the two bottom chambers in a coordinated manner. There are differences of opinion among experts and by previous studies regarding this method. Pacing is accomplished through pacemaker wires, which are placed in the right top chamber, the right bottom chamber and the left bottom chamber of the heart.

The setting we propose to adjust is the timing between the impulse sent between top and bottom chambers.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: CRT device settings
Comparision of A-V delay settings
Study Arms  ICMJE
  • Active Comparator: 1
    AVD set by taking the larger of 0.50ms or A-V interval 0.30
    Intervention: Device: CRT device settings
  • Active Comparator: 2
    AVD set by taking the larger of 0.50ms or A-V interval 0.50
    Intervention: Device: CRT device settings
  • Active Comparator: 3
    AVD set by taking the larger of 0.50ms or A-V interval 0.70
    Intervention: Device: CRT device settings
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 22, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2008)
100
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of chronic heart failure
  • patients on stable pharmacologic therapy for at least 3 months
  • EF< 35%
  • age >18 years
  • NYHA functional class III or IV
  • eligible for either CRT pacer or CRT defibrillator for heart failure
  • Ischemic or non-ischemic cardiomyopathy
  • patients that are able to tolerate VDD mode with a lower rate of 40bpm programming

Exclusion Criteria:

  • systolic blood pressure <70mmHg
  • Likely to receive a left ventricular assist device or cardiac transplant within 6 months of implant procedure
  • patients who have previously received a CRT device
  • documented atrial fibrillation
  • complete heart block
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00794183
Other Study ID Numbers  ICMJE 0303M44604
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Minnesota Medical Foundation
Investigators  ICMJE
Principal Investigator: David G Benditt, MD University of Minnesota
PRS Account University of Minnesota
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP