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

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Device: QuickOpt - SJM CRT (Group 1) Device: Control - SJM CRT (Group 2)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	BOOST: Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Stroke volume (SV) measured by aortic velocity time integral (AoVTI) [ Time Frame: Not assessed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Modified Specific Activity Scale (SAS); Quality-of-life (QOL) score as measured by Minnesota Living with Heart Failure (MLHF) questionnaire [ Time Frame: Not assessed ] [ Designated as safety issue: No ]
Ancillary Data: 6-minute hall walk; Intrinsic QRS width; Echo measurements (EDV, ESV, EF, LV mass, MR, TR, and interventricular and intraventricular mechanical delays) [ Time Frame: Not assessed ] [ Designated as safety issue: No ]
Ancillary Data Cont.: All-cause, cardiovascular and heart failure hospitalizations; All-cause, cardiovascular and heart failure mortality; Changes in paced/sensed AV and V-V delays; Percent atrial and ventricular pacing [ Time Frame: Not assessed ] [ Designated as safety issue: No ]

Enrollment:	17
Study Start Date:	June 2009
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: QuickOpt	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.
Active Comparator: Control	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-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.

Arms

Assigned Interventions

Experimental: QuickOpt

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.

Active Comparator: Control

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-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.

Detailed Description:

This is a prospective, randomized, and multicenter study
Patients who have received a replacement 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 ("QuickOpt") or Group 2 ("Control").

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929474

Locations

United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Mississippi
Hattiesburg Clinic, P.A./Southern Heart Center
Hattiesburg, Mississippi, United States, 39401

Sponsors and Collaborators

St. Jude Medical

More Information

No publications provided

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00929474 History of Changes
Other Study ID Numbers:	CRD466
Study First Received:	June 25, 2009
Last Updated:	January 2, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013