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

NCT00929474 | Terminated Results

• 1 other identifier: CRD466
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)

  The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.

  12 months

Study Arms (2)

QuickOpt

EXPERIMENTAL

Device: QuickOpt - SJM CRT (Group 1)

Control

ACTIVE COMPARATOR

Device: Control - SJM CRT (Group 2)

Interventions

QuickOpt - SJM CRT (Group 1) DEVICE

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.

QuickOpt

Control - SJM CRT (Group 2) DEVICE

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient underwent a CRT replacement within the last two weeks, triggered by either the elective replacement indicator (ERI)/end of life (EOL), or by receiving a CRT-D device as an upgrade from a CRT-P device.
• Patient has received an FDA approved SJM CRT device as a replacement to the old CRT device within the last two weeks.
• Patient has the ability to complete a 6-minute hall walk without any assistance.
• Patient is willing to provide written informed consent.
• Patient has the ability to independently comprehend and complete a QOL questionnaire.
• Patient is geographically stable and is willing to comply with the required follow-up schedule.

You may not qualify if:

• Patient had paced/sensed AV and/or V-V delay optimization using QuickOpt before CRT replacement.
• Patient had any paced/sensed AV and/or V-V delay optimization within 3 months before CRT replacement.
• Patient has an ability to walk ≥ 450 meters (≥ 1476 feet) in 6 minutes.
• Adequate patient's echocardiography/Doppler images will not be available.
• Patient is expected to receive a heart transplant during the duration of the study.
• Patient has an epicardial ventricular lead system (Active or Inactive).
• Patient has limited intrinsic atrial activity (≤ 40 bpm).
• Patient has persistent or permanent atrial fibrillation (AF).
• Patient has 2° or 3° heart block.
• Patient's life expectancy is less than 1 year.
• Patient is less than 18 years old.
• Patient is pregnant.
• Patient is on IV inotropic agents 1 month prior to CRT replacement.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Hattiesburg Clinic, P.A./Southern Heart Center

Hattiesburg, Mississippi, 39401, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Manager of Clinical Studies
• Organization: St. Jude Medical

klee3@sjm.com

818-493-2522

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 29, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 4, 2019
• Results First Posted: August 23, 2013

Record last verified: 2019-01

Locations

US (2)