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

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Insertable Cardiac Monitoring Device Reactive Oxygen Species Following Aortic Valve Replacement Biological Factors Associated With Subclinical Valvular Thrombosis Hemodynamic Comparison of Tissue Aortic Valves Volume Challenge Added to DSE in the Diagnosis of Severe LFLGAS Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis The Effects of High Spinal Anesthesia on Heart Function, Stress Response and Pain Control in Aortic Valve Surgery A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan) Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Efficacy of Angiotensin Receptor Blocker Following aortIc Valve Intervention for Aortic STenOsis: a Randomized mulTi-cEntric Double-blind Phase II Study Prehabilitation to Improve Functional and Clinical Outcomes in Patients With 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Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed Echocardiography Podocan and Wnt Pathway in Left Ventricular Remodeling of Aortic Stenosis Preoperative Assessment of Aortic Valve Stenosis and Coronary Artery Disease Statin Therapy in Asymptomatic Aortic Stenosis Validation of the “TASQ” in Patients Undergoing SAVR or TF-TAVI Analysis and Comparative Evaluation of Aortic Calcium by Computed Tomography and Histopathology in Patients With Aortic Stenosis Improving Echo Measurements in the Diagnosis of Aortic Stenosis accuRate Evaluation of Benefit With Optimal Medical Treatment With or With-Out Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis – REBOOT-PARADOX Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement Randomized Study for the Optimal Treatment of Symptomatic Patients With Low Gradient Severe Aortic Valve Stenosis and Preserved Left Ventricular Ejection Fraction Microvascular Dysfunction in Aortic Stenosis Percutaneous Aortic 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Brief Title

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

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

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
    

Detailed Description

      Background and Rationale

      Transcatheter aortic valve implantation (TAVI) is a minimally invasive treatment option for
      patients suffering from severe symptomatic aortic stenosis. Superiority of TAVI over medical
      treatment has been shown in the randomized PARTNER B trial followed by the PARTNER A trial
      showing non-inferiority over a more invasive open-heart surgical aortic valve replacement in
      high-risk patients. Over the last years, many patients have been successfully treated with
      TAVI worldwide.

      Peri- and post-procedural morbidity differed considerably between the surgical and
      interventional treatment group in the PARTNER A trial: while major bleeding (19.5% vs 9.3% at
      30 days) and new onset atrial fibrillation (16% vs 8.6% at 30 days) occur more often in
      surgically treated patients, vascular access complications (3.8 vs 17% at 30 days) and
      neurologic events (5.5% vs 2.4% at 30 days) are more frequently encountered in the TAVI
      population. The higher rate of neurologic events in the TAVI group was of particular concern,
      given its association with a higher mortality and the clinical impact of major neurologic
      events on patient's quality of life and daily functioning. Only about 40-50% of strokes occur
      intra-procedurally, followed by a higher hazard rate in the first week and a constant hazard
      thereafter. After 30 months, the surgical group experienced a numerically higher stroke rate,
      although not statistically significant. Measures to reduce procedural and post-procedural
      stroke rate were and are still looked for.

      While procedural strokes can be most likely reduced by improvements in valve delivery systems
      (smaller delivery systems) and more operator experience, cerebral protection devices are
      currently tested in trials but preliminary results are rather disappointing. Risk factors for
      post-procedural strokes after TAVI are a previous history of stroke, more extensive
      peripheral vascular disease, and higher functional class.

      A subgroup of patients of particular concern are patients suffering from atrial fibrillation:
      predictor of early (day 1-30) cerebrovascular events was new-onset atrial fibrillation (OR
      2.76), whereas chronic atrial fibrillation was a predictor (OR 2.84) for the occurrence of
      late (>30 days) cerebrovascular events. Amat-Santos reported a higher rate of
      strokes/systemic embolism in patients with in hospital new onset atrial fibrillation after
      TAVI (13.6% vs 3.2% after 30 days). Patients diagnosed with new onset atrial fibrillation
      during or after the procedure in which no anticoagulation was initiated experienced an
      alarmingly high 30-day stroke rate of 40%.

      Despite these results and the high prevalence of atrial fibrillation (AF) of about 33% in the
      overall TAVI population, only 30% of AF patients were on vitamin K antagonists (VKA) before,
      and only 70% after TAVI. While oral anticoagulation is an effective medical treatment for
      ischemic stroke prevention in these patients, it is often withheld from patients given their
      high risk of bleeding. TAVI patients typically not only suffer from much co-morbidity and are
      poly-medicated, but also suffer from a lot of bleeding risk factors. The bleeding risk score
      (HASBLED score) expresses the risk of major bleeding with a scoring system consisting of 9
      individual risk factors for bleeding; a patient is at high risk for bleeding, if 3 or more
      factors are present. The stroke risk score (CHA2DS2-Vasc score) comprises of 9 individual
      risk scores for stroke in patients suffering from atrial fibrillation. Both risk scores share
      common risk factors, such as age, hypertension and previous stroke. It is therefore not
      surprising that patients at highest risk for stroke are at the same time at highest risk for
      major bleedings. The TAVI population forms such a high risk group with a high prevalence of
      the above risk factors: average patients age in the PARTNER trial was 84 years, with 11%
      showing severe renal impairment, about 75% had an indication for concomitant acetylsalicylic
      acid use and all suffered per definition from heart failure. In Stortecky's study on TAVI
      patients suffering AF, the average CHA2DS2-Vasc score was 4.5, with >95% of patients having a
      score >3.

      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 TAVI patient
      population: 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.

      Clinical studies proved this concept to be true: the PROTECT-AF study randomized >700
      patients to either LAA occlusion or medical therapy (VKA). At one year, non-inferiority of
      LAAO was proven, with numerically less embolic events in the LAAO group. At a European
      conference (EuroPCR conference) 2013, Holmes (principal investigator of the PROTECT-AF trial)
      reported 4-year follow-up data with a significant 40% reduction of the composite of
      stroke/peripheral embolism/cardiovascular death and a 34% reduction of all cause mortality in
      the LAAO group as compared to oral anticoagulation. By reducing bleeding complications, it
      can be anticipated that morbidity and mortality will continue to diverge between the two
      groups. Comparable results from a large registry using Amplatzer devices (St. Jude Medical,
      St. Paul, USA) for LAAO were reported: after an average follow-up of 32 months,
      cardiovascular death, stroke, and peripheral embolism occurred in 7% of patients. In the
      latter study, oral anticoagulation was instantly stopped after LAAO in all patients.

      In the here proposed "Randomized Comparison of Left Atrial Appendage Occlusion versus
      Standard Medical Therapy of Atrial Fibrillation in Patients Undergoing Transfemoral
      Transcatheter Aortic Valve Implantation", study the investigators 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. The design is an
      investigator-initiated, randomized, multicenter, non-blinded, all-comers study. It is
      understood, that this is a pilot trial with the intention to prove safety, but which is
      underpowered to show superiority over medical therapy.
    


Study Type

Interventional


Primary Outcome

embolic events

Secondary Outcome

 All deaths

Condition

Atrial Fibrillation

Intervention

LAAO

Study Arms / Comparison Groups

 Treatment
Description:  Patient receiving LAAO

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

80

Start Date

May 15, 2016

Completion Date

May 7, 2023

Primary Completion Date

May 7, 2023

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Fabian Nietlispach, MD PhD, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT03088098

Organization ID

2015-0459


Responsible Party

Sponsor

Study Sponsor

University of Zurich

Collaborators

 Abbott Medical Devices

Study Sponsor

Fabian Nietlispach, MD PhD, Principal Investigator, University of Zurich


Verification Date

October 2018