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

NCT03088098 | Completed

• 1 other identifier: 2015-0459
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

left atrial appendage occlusion; transcatheter aortic valve implantation; atrial fibrillation

Outcome Measures

Primary Outcomes (3)

• embolic events

  Assessed by telephone interview

  1 year

• major bleeding

  Assessed by telephone interview

  1 year

• cardiovascular mortality

  Assessed by telephone interview

  1 year

Secondary Outcomes (6)

• All deaths

  30 days

• All deaths

  1 year

• All deaths

  3 years

• All deaths

  5 years

• Device success

  30 days

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Patient receiving LAAO

Device: LAAO

Control

NO INTERVENTION

Patient undergoing medical therapy for stroke prevention

Interventions

LAAO DEVICE

Left atrial appendage occlusion for stroke prevention

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe aortic valve stenosis with an indication for aortic valve replacement (e.g., symptomatic patient, decreased left ventricular (LV) function)
• Suitable anatomy for transfemoral TAVI with the Portico Transcatheter Aortic Valve System (ileofemoral arterial diameter, annulus-coronary distance, annulus diameter)
• No mobile thrombus in the LA or LAA precluding LAAO
• Atrial fibrillation with a CHA2DS2-Vasc-Score \>=1. No limitation regarding the nature of atrial fibrillation (paroxysmal, permanent, persistent)

You may not qualify if:

• Pregnancy
• Known intolerance to aspirin, heparin, contrast media or clinically manifest nickel allergy
• Inability to provide informed consent
• Mechanical heart valve or other indication for oral anticoagulation (i.e. recent pulmonary embolism)
• Contraindication for oral anticoagulation
• Currently participating in another trial

Sponsors & Collaborators

• University of Zurich: lead
• Abbott Medical Devices: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• Jakob P, Heinz P, Gong Y, Chen M, Binder RK, Held U, Taramasso M, Paneni F, Schuetz P, Haager PK, Kasel M, Pedrazzini G, Windecker S, Moccetti M, Pilgrim T, Luscher TF, Stahli BE, Nietlispach F; TAVI-LAAO Investigators. Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Intervention: A Randomized Pilot Study. Struct Heart. 2025 Oct 8;9(12):100735. doi: 10.1016/j.shj.2025.100735. eCollection 2025 Dec.

  PMID: 41321777 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• Philipp Jakob, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: March 23, 2017
• Study Start: May 2, 2016
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)