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

Not Applicable

Terminated

• Conditions: Aortic Valve Disorder
• Interventions: Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations); Device: WATCHMAN

• Registration Number: NCT02678871
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-28
• Study First Submitted QC: 2016-02-05
• Study First Posted: 2016-02-10
• Study Start: 2017-03-08
• Primary Completion: 2022-10-31
• Study Completion: 2022-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All study participants	WATCHMAN	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.
All study participants	Lotus 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) 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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie; 🇩🇪 Rostock, Germany

Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milano, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Santa Maria University Hospital,; 🇵🇹 Lisbon, Portugal

Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "; 🇮🇹 Catania, Italy

Inselspital Bern; 🇨🇭 Bern, Switzerland