Study Stopped
funding difficulty
A Pilot Study Comparing the Programmed Delay Between the Atrial and Ventricle Interval
BRAVO-CRT
A Pilot Study of theRelationship Between Atrio-Ventricular Delay and Changes in Biochemical Markers of Chronic Heart Failure During Cardiac Resynchronization Therapy (BRAVO-CRT)
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 heart-failure
Started Jun 2004
Longer than P75 for early_phase_1 heart-failure
1 active site
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
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 18, 2008
CompletedFirst Posted
Study publicly available on registry
November 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedJune 26, 2012
June 1, 2012
5.9 years
November 18, 2008
June 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the effect of CRT atrioventricular delay settings on biochemical markers in blood through 6 months
end of the study
Secondary Outcomes (4)
assess effects of echocardiogram through 6months after CRT on heart failure
end to study
assess the effects of minnesota Living with heart failure questionaire through 6 months after CRT on heart failure
end of study
assess effects of six minute hall walk through 6 months after CRt on heart failure
end of study
assess effects of SDANN through 6 months after CRT on heart failure
end of study
Study Arms (3)
1
ACTIVE COMPARATORAVD set by taking the larger of 0.50ms or A-V interval 0.30
2
ACTIVE COMPARATORAVD set by taking the larger of 0.50ms or A-V interval 0.50
3
ACTIVE COMPARATORAVD set by taking the larger of 0.50ms or A-V interval 0.70
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- Minnesota Medical Foundationcollaborator
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David G Benditt, MD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2008
First Posted
November 19, 2008
Study Start
June 1, 2004
Primary Completion
May 1, 2010
Study Completion
November 1, 2010
Last Updated
June 26, 2012
Record last verified: 2012-06