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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
Sponsor:
Collaborator:
Abbott Medical Devices
Information provided by (Responsible Party):
University of Zurich

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


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Aortic Stenosis Device: LAAO Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Active Comparator: Treatment
Patient receiving LAAO
Device: LAAO
Left atrial appendage occlusion for stroke prevention

No Intervention: Control
Patient undergoing medical therapy for stroke prevention



Primary Outcome Measures :
  1. embolic events [ Time Frame: 1 year ]
    Assessed by telephone interview

  2. major bleeding [ Time Frame: 1 year ]
    Assessed by telephone interview

  3. cardiovascular mortality [ Time Frame: 1 year ]
    Assessed by telephone interview


Secondary Outcome Measures :
  1. All deaths [ Time Frame: 30 days ]
    Assessed by medical chart review and telephone interview

  2. All deaths [ Time Frame: 1 year ]
    Assessed by medical chart review and telephone interview

  3. All deaths [ Time Frame: 3 years ]
    Assessed by medical chart review and telephone interview

  4. All deaths [ Time Frame: 5 years ]
    Assessed by telephone interview

  5. Device success [ Time Frame: 30 days ]
    Assessed by review of the implant procedure (fluoroscopy and echocardiography)

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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Switzerland
University Hospital Zurich
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Abbott Medical Devices
Investigators
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Principal Investigator: Fabian Nietlispach, MD PhD University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03088098     History of Changes
Other Study ID Numbers: 2015-0459
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Zurich:
left atrial appendage occlusion
transcatheter aortic valve implantation
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Aortic Valve Stenosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Valve Diseases
Ventricular Outflow Obstruction