Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage (TAVI-LAAC)

Insel Gruppe AG, University Hospital Bern

Status: Terminated

Conditions: Aortic Valve Disorder

Treatments: Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations); Device: WATCHMAN

Study type: Interventional

Funder types: Other

Identifiers

NCT02678871

2016-01-18

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

All study participants

Other group

Description:

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.

Treatment:

Device: WATCHMAN

Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)