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

January 31, 2019 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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").

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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-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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stroke Volume (SV) Measured by Aortic Velocity Time Integral (AoVTI)
Time Frame: 12 months
The BOOST study is prematurely terminated so there were no enough numbers of patients to have a meaningful measurement.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRD466

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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