Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in AF Undergoing TAVI (TAVI/LAAO)
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|ClinicalTrials.gov Identifier: NCT03088098|
Recruitment Status : Active, not recruiting
First Posted : March 23, 2017
Last Update Posted : October 12, 2018
Study category and Rationale Clinical study, Category A.
Clinical Phase: Post market study
Background and Rationale: Left atrial appendage occlusion (LAAO) allows avoiding oral anticoagulation and provides at the same time an at least equally good protection from strokes and peripheral embolism. It may therefore be an attractive alternative to oral anticoagulation in the patient population undergoing transcatheter aortic valve implantation (TAVI): the concept of LAAO is based on the fact that thrombus formation in atrial fibrillation occurs in >90% in the left atrial appendage (LAA). Mechanical occlusion of the LAA reduces the stroke risk by eliminating the source of thrombus formation. In the here proposed "Randomized Comparison of Left Atrial Appendage Occlusion versus Standard Medical Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve Implantation", study we test the hypothesis, that LAAO is superior to standard medical therapy in the high-risk TAVI population. This hypothesis has not been investigated by previous studies so far.
Overall Objective(s): Overall objective: to compare the safety (and efficacy) of LAAO using the St. Jude left atrial appendage closure device with standard medical therapy in a prospective, multi-center, randomized trial in patients undergoing TAVI in routine clinical practice.
Primary Objective: To assess the safety of the device intervention with regard to stroke prevention and prevention of bleeding complications in a patients population at high risk of stroke and bleeding.
Secondary Objectives: Short-term (procedural) safety of device intervention is assessed (rate of successful deployment of a left atrial appendage occluder; rate of kidney failure). As a further secondary objective, long-term effects of device intervention on stroke and bleeding prevention as well as mortality are assessed and compared to medical therapy.
Outcome(s): Primary: Composite endpoint of ischemic and hemorrhagic neurologic events, peripheral embolism, life-threatening/disabling and major bleeding complications and cardiovascular mortality at 1 year
Secondary: All deaths (cardiac and non-cardiac) at 30 days, 1, 3, and 5 years Device success at 30 days
In-hospital acute kidney injury (AKI)
Study design: An investigator-initiated, randomized, multicenter, non-blinded, all-comers study
Measurements and Procedures: 80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or SMT at the operators' discretion (medical group; antiplatelet therapy and oral anticoagulation or oral anticoagulation alone). All patients will be followed for up to 5 years. The primary analysis will be performed at 30 days and after completion of a 1-year follow-up.
80 patients in atrial fibrillation undergoing TAVI will be randomized in a non-blinded fashion (1:1 randomization) to LAAO (device group) or standard medical therapy (SMT) at the operators' discretion (medical group; antiplatelet therapy, oral anticoagulation or oral anticoagulation alone).
Estimated duration for the main investigational plan from start of screening of first participant to last participant processed and finishing the study: 6 years
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Aortic Stenosis||Device: LAAO||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in Atrial Fibrillation Undergoing Transfemoral Transcatheter Aortic Valve Implantation: The TAVI LAAO Trial|
|Study Start Date :||May 15, 2016|
|Estimated Primary Completion Date :||May 7, 2023|
|Estimated Study Completion Date :||May 7, 2023|
Active Comparator: Treatment
Patient receiving LAAO
Left atrial appendage occlusion for stroke prevention
No Intervention: Control
Patient undergoing medical therapy for stroke prevention
- embolic events [ Time Frame: 1 year ]Assessed by telephone interview
- major bleeding [ Time Frame: 1 year ]Assessed by telephone interview
- cardiovascular mortality [ Time Frame: 1 year ]Assessed by telephone interview
- All deaths [ Time Frame: 30 days ]Assessed by medical chart review and telephone interview
- All deaths [ Time Frame: 1 year ]Assessed by medical chart review and telephone interview
- All deaths [ Time Frame: 3 years ]Assessed by medical chart review and telephone interview
- All deaths [ Time Frame: 5 years ]Assessed by telephone interview
- Device success [ Time Frame: 30 days ]Assessed by review of the implant procedure (fluoroscopy and echocardiography)
- Acute Kidney Injury (Review of lab results: Peak value of Creatinin) [ Time Frame: Peak value of Creatinin at 48 hour, 72 hour after Procedure ]Review of lab results in hospital
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088098
|University Hospital Zurich|
|Zurich, ZH, Switzerland, 8091|
|Principal Investigator:||Fabian Nietlispach, MD PhD||University of Zurich|