Surgical PA-LAA Shunting: a Feasibility Study (PA-LAA)
Surgical PA-LAA Shunting for Management of Systemic Embolization in Patients With Atrial Fibrillation: a Feasibility Study
Atrial fibrillation is common and increases the risk of stroke. Traditionally patients are treated with blood thinning medications or at the time of surgery the part of the heart where blood clots form is cut out. Surgically cutting out the left atrial appendage can be difficult and complications can occur. An alternative strategy is to create a tunnel to increase blood flow and wash out the part of the heart where clots form.
This strategy has not been previously studied. The purpose of this study is to determine if creating a tunnel to increase blood flow is feasible and safe.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The goal is to understand the potential avenues to increase Left Atrial Appendage (LAA) flow in patients with Atrial Fibrillation (AF) to minimize systemic embolization risk. Flow modeling demonstrates that the anatomy of the LAA results in decreased velocities in the LAA apex. Introduction of a 3-4mm shunt in the apex can result in increased velocity, less stasis and a lower propensity for thrombus formation. Small (<8mm) inter-chamber shunts can exist in humans with no long term hemodynamic consequences in otherwise structurally normal hearts - making a strategy of pulmonary artery (PA) to LAA shunt an attractive potential therapy given anatomic proximity and gradient differential between the cardiac chambers.
This will be a 5 patient first-in-human feasibility study. The population will include patients undergoing CABG or other cardiovascular surgery with AF and a CHADS2 score >1 in whom the treating team deems traditional therapy with anticoagulants is prohibitive or ineffective (dialysis or EGFR preoperatively <15, previous bleeding with non-reversible pathology, clinically deemed contraindicated to oral anticoagulant). The intervention will be PA-LAA shunt creation at the time of surgery. As this is a single arm study there will be no comparison group.
Studietype
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ontario
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Ottawa, Ontario, Canada, K1Y4W7
- University of Ottawa Heart Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years undergoing CV surgery
- History of AF with a CHADS2 score >1
Relative contraindication to OAC as determined by the heart team
- Dialysis or preoperative eGFR of <15
- Bleeding on DOAC/Coumadin with non-reversible pathology
- Other medical condition that makes the patient ineligible for OAC
- Anatomic proximity of LAA and PA on preoperative CT scan suitable for shunt creation
Exclusion Criteria:
- LVEF <40%
- History of VTE - either DVT or PE
- Resting baseline preoperative O2 sats <98%
- Inability of the patient to provide written informed consent
- Greater than moderate valvular heart disease which is not to be addressed during surgical intervention
- Documented mPA to PCWP <5mmHg
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Procedure arm
At the time of surgery a covered stent will be inserted through the atriotomy into the left pulmonary artery and balloon dilated to stabilize the device.
The target shunt diameter will be 3.5-4 mm to minimize LAA stasis.
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At the time of surgery a covered stent will be inserted through the atriotomy into the left pulmonary artery and balloon dilated to stabilize the device.
The target shunt diameter will be 3.5-4 mm to minimize LAA stasis.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Composite of device safety and performance
Tidsramme: 3 months
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At three months feasibility will be met if there is no:
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3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Device related performance - maintaining patency
Tidsramme: 1 year
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Shunt patency as assessed by TEE
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1 year
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Systemic embolization
Tidsramme: 1 year
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Systemic embolization - includes stroke, TIA, MI or peripheral embolization attributable to either LAA thrombus or paradoxical embolization as clinically diagnosed by treating physician
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1 year
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Systemic saturations
Tidsramme: 1 year
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Resting saturations <92% - threshold
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1 year
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Need for intervention to close the shunt
Tidsramme: 1 year
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Need for intervention to close the shunt either surgically or percutaneously to
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1 year
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20200646-01H
Plan for individuelle deltakerdata (IPD)
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