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

Aortic Valve Disorder Clinical Trial

— TAVI-LAAC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02678871
• Other study ID #: 2016-01-18
• Status: Terminated
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Aortic Valve Disorder

Intervention

Device:
• 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)
• WATCHMAN
LAA closure with the WATCHMAN device

Locations

Country	Name	City	State
Germany	Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie	Rostock
Italy	Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "	Catania
Italy	Azienda Ospedaliero Universitaria Pisana	Pisa
Italy	Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato	San Donato Milanese	Milano
Portugal	Santa Maria University Hospital,	Lisbon
Switzerland	Inselspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Countries where clinical trial is conducted

Germany,  Italy,  Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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