Aortic Valve Disorder
Conditions
Keywords
Aortic Valve Stenosis, Left atrial appendage
Brief summary
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.
Interventions
DEVICELotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
Patients meeting clinical and anatomical pre-requisites will undergo TAVI with the Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
DEVICEWATCHMAN
LAA closure with the WATCHMAN device
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early safety (composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days) | 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 |
Countries
Germany, Italy, Portugal, Switzerland
Outcome results
None listed