NCT00929474

BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement

BOOST: Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure. Additionally in CRT patients it has been demonstrated that optimizing paced/sensed atrioventricular (AV) and interventricular (V-V) timings leads to immediate hemodynamic benefits and further improves cardiac function. Recent studies have shown that optimal paced/sensed AV and V-V delays change over time, which raises the question of how often optimization should be repeated. Thus, frequent re-optimization of these delays might be beneficial for maintaining significant improvement of cardiac function. However, it remains to be evaluated whether timing optimization may be beneficial on patients who have received CRT for a number of years and are now having the CRT device replaced.

Detailed description

* This is a prospective, randomized, and multicenter study * Patients who have received a replacement St. Jude Medical(SJM) CRT device, either CRT-P or CRT-D, within the last two weeks post CRT replacement will be considered for enrollment in the study. * Baseline measurements will be performed at the time of enrollment. * Patients are followed up to 12 months post CRT replacement with data collected at 3, 6, 9 and 12 months post CRT replacement. * Patients will be randomized at enrollment to either Group 1 (use of SJM algorithm to optimize programming) or Group 2 ("Control").

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	QuickOpt - SJM CRT (Group 1)	The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed AV and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
DEVICE	Control - SJM CRT (Group 2)	The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-06-29
• Last updated: 2019-02-04
• Results posted: 2013-08-23

Locations

2 sites across 1 country: United States