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

NCT ID: NCT00794183

Last Updated: 2012-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2010-11-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

AVD set by taking the larger of 0.50ms or A-V interval 0.30

Group Type: ACTIVE_COMPARATOR

CRT device settings

Intervention Type: DEVICE

Comparision of A-V delay settings

2

AVD set by taking the larger of 0.50ms or A-V interval 0.50

Group Type: ACTIVE_COMPARATOR

CRT device settings

Intervention Type: DEVICE

Comparision of A-V delay settings

3

AVD set by taking the larger of 0.50ms or A-V interval 0.70

Group Type: ACTIVE_COMPARATOR

CRT device settings

Intervention Type: DEVICE

Comparision of A-V delay settings

Interventions

CRT device settings

Comparision of A-V delay settings

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minnesota Medical Foundation

OTHER

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David G Benditt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

0303M44604

Identifier Type: -

Identifier Source: org_study_id