Left Atrial Appendage Occlusion Study II (LAAOSII)
Phase III Pilot Study - Left Atrial Appendage Occlusion Study
A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke.
Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best medical therapy as per guidelines.
Main research questions:
- Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?
- In patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin?
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events.
LAAOS pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. From this study we envision a a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass
A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors:
- age => 65 years
- hypertension
- diabetes mellitus, or
- heart failure/left ventricular ejection fraction < 50%
Exclusion Criteria:
- Patients in whom surgical AF ablation (MAZE or otherwise) is planned
- Planned "off-pump" surgery
- Planned implantation of a mechanical valve
- Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Occlusion arm
Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.
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Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
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Comparatore attivo: Medical arm
Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.
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Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication.
Lasso di tempo: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
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Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding.
Lasso di tempo: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
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Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Richard Whitlock, MD, FRCSC, McMaster University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LAAOSII
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 .
Prove cliniche su Surgical occlusion of the left atrial appendage
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Ya-Wei XuWest China Hospital; Ruijin Hospital; Shanghai Ninth People's Hospital Affiliated... e altri collaboratoriSconosciutoIctus | Fibrillazione atriale non valvolare