Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is a common comorbidity of patients candidates to transcatheter aortic valve implantation (TAVI). The management of chronic oral anticoagulation (OAC) for the prevention of ischemic stroke is very challenging in this population of complex and frail subjects. Since the percutaneous left atrial appendage (LAA) closure with the WATCHMAN device proved promising safety and efficacy results in randomized comparisons with OAC (current standard of care), the aim of the current study is to assess the feasibility and the early safety of performing TAVI with the Lotus System and percutaneous LAA closure with the WATCHMAN device at the same session.

Official Title
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Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage

Conditions
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Aortic Valve Disorder

Intervention / Treatment
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* Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
* Device: WATCHMAN


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: TAVI candidates Elderly patients with symptomatic, severe, calcific, native aortic valve stenosis, assessed by echocardiography AVA up to 1.0 cm2 or AVAi up to 0.6 cm2m2 and mean pressure gradient 40 mmHg or jet velocity 4 ms Inoperable or at increased surgical risk (according to multidisciplinary heart team decision) Non-valvular AF (paroxysmal, persistent or permanent) CHA2DS2-VASc ≥ score HAS-BLED score ≥ 2 Written informed consent Aortic annulus size ≥ 20 mm and ≤ 27 mm Adequate LAA ostium diameter (17 31mm) Exclusion Criteria: Previous TAVI Previous LAA closure (surgical or percutaneous) Previous RF ablation of AF Need for long-term OAC (history of pulmonary embolism, mechanical heart valve) Contraindication to aspirin Relevant CAD requiring revascularization Infective endocarditis LV ejection fraction < 20 percent Cardiogenic shock or hemodynamic instability Symptomatic carotid disease Life expectancy < 1 year Severe renal failure (dialysis or serum creatinine level > 3.0 mg/dl or 265 μmol/L) CVE within the past 3 months Acute complications occurring during TAVI procedure Congenital unicuspid aortic valve Femoral artery lumen diameter <6.0 mm or <6.5 mm (for the 23-mm valve or the 25-mm and 27-mm valves, respectively) Documented LAA and/or LV thrombi Severe MR Atrial septal defect

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All study participants<br>Patients meeting clinical and anatomical pre-requisites will undergo TAVI with the LOTUS or Acurate Neo heart valve system (or subsequent CE marked iterations) and LAA closure with the WATCHMAN device in the same setting. Dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) will be prescribed for 6 months followed acetylsalicylic acid indefinitely. Follow-up will be performed after 1 month, 6 months and 1 year. | Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)<br>* Patients meeting clinical and anatomical pre-requisites will undergo TAVI with the Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)<br>Device: WATCHMAN<br>* LAA closure with the WATCHMAN device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early safety (composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days) | Early safety - composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days. Composite defined as all cause-mortality, all stroke (disabling and non-disabling), life threatening bleeding, acute kidney injury (stage 2 or 3, including renal replacement therapy), coronary artery obstruction requiring intervention, major vascular complications, valve-related dysfunction requiring repeat procedure, pericardial effusion requiring pericardial drainage, and LAA device embolization requiring surgical intervention | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Stenosis, Left atrial appendage