Comparison of Left Atrial Appendage Occlusion vs Standard Medical Therapy in Patients in AF Undergoing TAVI

Summary

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

Conditions

• Atrial Fibrillation
• Aortic Stenosis

Interventions

DEVICE

LAAO

Left atrial appendage occlusion for stroke prevention

Sponsors & Collaborators

• Abbott Medical Devices

  collaborator INDUSTRY

• University of Zurich

  lead OTHER

Principal Investigators

• Philipp Jakob, MD · University of Zurich

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-05-02

Primary Completion

2025-02-05

Completion

2025-02-05

Countries

• Switzerland

Study Locations