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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00146848
PEGASUS CRT Study: Atrial Support Study in Cardiac Resynchronization Therapy (PEGASUS CRT)
20 dicembre 2011 aggiornato da: Boston Scientific Corporation
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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1742
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- The Cleveland Clinic Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: DDD-40
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.
|
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.
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Comparatore attivo: DDDR-40
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.
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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.
|
|
Comparatore attivo: DDD-70
Atrial support pacing in this arm will be delivered when the rate falls below 70 bpm.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinical Composite Score
Lasso di tempo: From randomization (6-weeks) through 12-month visit
|
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.
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From randomization (6-weeks) through 12-month visit
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Quality of Life
Lasso di tempo: From randomization (6-weeks) through 12-month visit
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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.
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From randomization (6-weeks) through 12-month visit
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Change in Self Assessed Physical Activity
Lasso di tempo: From randomization (6-weeks) through 12-month visit
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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.
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From randomization (6-weeks) through 12-month visit
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: David O. Martin, MD, MPH, The Cleveland Clinic
- Investigatore principale: John Day, Utah Heart Clinic, LDS Hospital
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2004
Completamento primario (Effettivo)
1 gennaio 2009
Completamento dello studio (Effettivo)
1 febbraio 2009
Date di iscrizione allo studio
Primo inviato
2 settembre 2005
Primo inviato che soddisfa i criteri di controllo qualità
6 settembre 2005
Primo Inserito (Stima)
7 settembre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
28 dicembre 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 dicembre 2011
Ultimo verificato
1 dicembre 2011
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CR-CA-100604-H
- PEGASUS
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .