NCT00146848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,742

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 23, 2010

Completed
Last Updated

December 28, 2011

Status Verified

December 1, 2011

Enrollment Period

4.1 years

First QC Date

September 2, 2005

Results QC Date

February 28, 2010

Last Update Submit

December 20, 2011

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

  • Change in Quality of Life

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

  • Change in Self Assessed Physical Activity

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

Study Arms (3)

DDD-40

ACTIVE COMPARATOR

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.

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

DDDR-40

ACTIVE COMPARATOR

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.

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

DDD-70

ACTIVE COMPARATOR

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

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

Interventions

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.

DDD-40DDD-70DDDR-40

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Cleveland Clinic Hospital

Cleveland, Ohio, 44195, United States

Location

Related Publications (2)

  • 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.

    PMID: 17174627BACKGROUND

  • 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.

    PMID: 22830441DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Limitations and Caveats

Lack of longer-term follow-up. Single blind design where investigator could be aware of treatment assignment. Two conservative atrial support pacing modes; results should not be extended to substantially more atrial pacing and higher heart rates.

Results Point of Contact

Title
Kira Stolen
Organization
Clinical Affairs
cshd@bsci.com
1 800 CARDIAC

Study Officials

  • David O. Martin, MD, MPH

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • John Day

    Utah Heart Clinic, LDS Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

December 1, 2004

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

December 28, 2011

Results First Posted

September 23, 2010

Record last verified: 2011-12

Locations

US(1)