A Pilot Study Comparing the Programmed Delay Between the Atrial and Ventricle Interval

Heart Failure Clinical Trial

— BRAVO-CRT  

Official title:

A Pilot Study of theRelationship Between Atrio-Ventricular Delay and Changes in Biochemical Markers of Chronic Heart Failure During Cardiac Resynchronization Therapy (BRAVO-CRT)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00794183
• Other study ID #: 0303M44604
• Status: Terminated
• Phase: Phase 0
• First received: November 18, 2008
• Last updated: June 22, 2012
• Start date: June 2004
• Est. completion date: November 2010

Study information

• Verified date: June 2012
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: November 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• CRT device settings
Comparision of A-V delay settings

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Minnesota Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of CRT atrioventricular delay settings on biochemical markers in blood through 6 months		end of the study	No
Secondary	assess effects of echocardiogram through 6months after CRT on heart failure		end to study	No
Secondary	assess the effects of minnesota Living with heart failure questionaire through 6 months after CRT on heart failure		end of study	No
Secondary	assess effects of six minute hall walk through 6 months after CRt on heart failure		end of study	No
Secondary	assess effects of SDANN through 6 months after CRT on heart failure		end of study	No