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Heart FailurePhase 4PEGASUS CRTNCT00146848

PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy

A Phase 4 study testing Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices in people with Heart Failure, run by Boston Scientific Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,742 participants
Where
1 siteUnited States
Study dates
Dec 2004to Feb 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Cleveland Clinic Hospital

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Pacing Evaluation - Atrial Support Study in Cardiac Resynchronization Therapy

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.

Read the 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.

Conditions
Heart Failure
Being tested
Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devicesDevice

    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.

Study groups in NCT00146848
Study groupRoleWhat they receive
DDD-40Active comparatorDDD-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.
Receives: Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
DDDR-40Active comparatorDDDR-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.
Receives: Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices
DDD-70Active comparatorAtrial support pacing in this arm will be delivered when the rate falls below 70 bpm.
Receives: Device: Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization (6-weeks) through 12-month visit

Secondary outcomes (2)

  1. 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.

    Measured: From randomization (6-weeks) through 12-month visit

  2. 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.

    Measured: From randomization (6-weeks) through 12-month visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2005 (estimated)
  2. Study startDec 2004
  3. Primary completionJan 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00146848
Sponsor's protocol ID
CR-CA-100604-H
Other IDs
PEGASUS
Acronym
PEGASUS CRT
Status last verified
Dec 2011
First submitted
2 Sep 2005
Last updated
28 Dec 2011
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17174627

  • 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.

    PubMed 22830441

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atrial support pacing through cardiac resynchronization therapy. Device: RENEWAL family of CRT-D devices in people with Heart Failure, run by Boston Scientific Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Composite Score (time frame: From randomization (6-weeks) through 12-month visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00146848, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2011.

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PEGASUS CRT Clinical Trial NCT00146848 | AzTrials