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?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Occlusion arm
Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.
|
Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
|
|
Aktiv komparator: Medical arm
Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.
|
Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication.
Tidsramme: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
|
Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding.
Tidsramme: Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
|
Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Richard Whitlock, MD, FRCSC, McMaster University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LAAOSII
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .