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PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy (PEGASUS CRT)

Primary Purpose

Heart Failure

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who meet current indications for the CONTAK RENEWAL® family of cardiac resynchronization therapy defibrillator (CRT-D) devices or future Food and Drug Administration (FDA) approved Guidant CRT-D devices Patients who sign and date a Patient Informed Consent at, or prior to, the implant visit Patients who are in sinus rhythm at the time of implant Patients who remain in the clinical care of the enrolling physician in approved centers Patients who are on optimal pharmacologic therapy or who have developed a recent implantable cardioverter defibrillator (ICD) indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy Exclusion Criteria: Patients whose medical condition is expected to preclude the use of the protocol-required pacing mode (dual chamber pacing [DDD or DDDR]) and respective lower rate limits Patients with permanent atrial fibrillation or atrial flutter Patients who are in complete heart block Patients who have previously had a pacemaker, ICD, or CRT device Patients whose life expectancy is less than 12 months due to other medical conditions Patients who are expected to receive a heart transplant during the duration of the study Patients who have other cardiac surgeries or procedures planned but not yet performed Patients who currently have or who are likely to receive a tricuspid valve prosthesis Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study. Patients who are younger than 18 years of age Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study Patients who are or become pregnant

Sites / Locations

  • The Cleveland Clinic Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

DDD-40

DDDR-40

DDD-70

Arm Description

DDD-40 for this trial is the comparator arm. Even though patients are receiving a CRT-D device, atrial support pacing in this arm will be limited as the device will not pace unless the rate falls below 40 bpm.

DDDR-40 programming will initiate atrial support pacing if the rate falls below 40 bpm or if atrial support is needed in response to increased activity.

Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm.

Outcomes

Primary Outcome Measures

Clinical Composite Score
The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association [NYHA] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.

Secondary Outcome Measures

Change in Quality of Life
Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.
Change in Self Assessed Physical Activity
Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.

Full Information

First Posted
September 2, 2005
Last Updated
December 20, 2011
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00146848
Brief Title
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy
Acronym
PEGASUS CRT
Official Title
Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will look at different pacing modes (how a device is programmed to pace one's heart), and how these modes may assist in one's daily activities and how one is feeling.
Detailed Description
PEGASUS CRT is a multicenter trial that will assess the effect of a cardiac resynchronization therapy defibrillator (CRT-D) device programmed to DDD-70 or DDDR-40 compared to a CRT device programmed to DDD-40 in heart failure patients. The effect of atrial support pacing in heart failure patients will be assessed using a clinical composite rating. A sub-study will evaluate the effect pacing mode has on exercise capacity in this heart failure population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1742 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DDD-40
Arm Type
Active Comparator
Arm Description
DDD-40 for this trial is the comparator arm. Even though patients are receiving a CRT-D device, atrial support pacing in this arm will be limited as the device will not pace unless the rate falls below 40 bpm.
Arm Title
DDDR-40
Arm Type
Active Comparator
Arm Description
DDDR-40 programming will initiate atrial support pacing if the rate falls below 40 bpm or if atrial support is needed in response to increased activity.
Arm Title
DDD-70
Arm Type
Active Comparator
Arm Description
Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm.
Intervention Type
Device
Intervention Name(s)
Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
Intervention Description
All subjects in this trial receive the same device. For the purpose of this trial, "intervention" is programming mode and lower rate limit to deliver atrial support pacing in the two treatment arms, while the control arm will receive programming where limited atrial support pacing is delivered. DDD-70 and DDDR-40 are the treatment arms programmed to receive atrial support pacing and will be compared to the DDD-40 arm.
Primary Outcome Measure Information:
Title
Clinical Composite Score
Description
The primary outcome measure classified patients as improved, unchanged or worsened, based on a 4 components clinical composite score using the following four components: death, heart failure hospitalization, New York Heart Association [NYHA] class, patient's Global Assessment rating. Best value is improved, whereas worst value is worsened.
Time Frame
From randomization (6-weeks) through 12-month visit
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
Quality of Life as assessed by the Minnesota Living with Heart Failure Questionniare for those patients with paired data at 6 weeks and 12 months. This score is on a scale of 0(best)- 105(worst). A negative change denotes improvement.
Time Frame
From randomization (6-weeks) through 12-month visit
Title
Change in Self Assessed Physical Activity
Description
Physical activity was assessed using the Physical Activity Scale of the Elderly (PASE) questionnaire for those patients with paired data available at the 6 week and 12 month visits. The PASE is designed to assess physical activity in older persons. The total PASE score was computed by multiplying the amount of time spent in each activity (hours/week) or participation (yes/no) in an activity by empirically derived item weights and summing over all activities. PASE scores for this study ranged from 0 to 756 with higher scores indicating more physical activity.
Time Frame
From randomization (6-weeks) through 12-month visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who meet current indications for the CONTAK RENEWAL® family of cardiac resynchronization therapy defibrillator (CRT-D) devices or future Food and Drug Administration (FDA) approved Guidant CRT-D devices Patients who sign and date a Patient Informed Consent at, or prior to, the implant visit Patients who are in sinus rhythm at the time of implant Patients who remain in the clinical care of the enrolling physician in approved centers Patients who are on optimal pharmacologic therapy or who have developed a recent implantable cardioverter defibrillator (ICD) indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy Exclusion Criteria: Patients whose medical condition is expected to preclude the use of the protocol-required pacing mode (dual chamber pacing [DDD or DDDR]) and respective lower rate limits Patients with permanent atrial fibrillation or atrial flutter Patients who are in complete heart block Patients who have previously had a pacemaker, ICD, or CRT device Patients whose life expectancy is less than 12 months due to other medical conditions Patients who are expected to receive a heart transplant during the duration of the study Patients who have other cardiac surgeries or procedures planned but not yet performed Patients who currently have or who are likely to receive a tricuspid valve prosthesis Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study. Patients who are younger than 18 years of age Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study Patients who are or become pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O. Martin, MD, MPH
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Day
Organizational Affiliation
Utah Heart Clinic, LDS Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17174627
Citation
Martin DO, Stolen KQ, Brown S, Yu Y, Christie C, Doshi SK, Smith JM, Gold MR, Day JD. Pacing Evaluation-Atrial SUpport Study in Cardiac Resynchronization Therapy (PEGASUS CRT): design and rationale. Am Heart J. 2007 Jan;153(1):7-13. doi: 10.1016/j.ahj.2006.10.013.
Results Reference
background
PubMed Identifier
22830441
Citation
Martin DO, Day JD, Lai PY, Murphy AL, Nayak HM, Villareal RP, Weiner S, Kraus SM, Stolen KQ, Gold MR. Atrial support pacing in heart failure: results from the multicenter PEGASUS CRT trial. J Cardiovasc Electrophysiol. 2012 Dec;23(12):1317-25. doi: 10.1111/j.1540-8167.2012.02402.x. Epub 2012 Jul 25.
Results Reference
derived

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PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

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