Clinical trial NCT02678871: Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Official title: Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Valve Disorder
Keywords: Aortic Valve Stenosis
Left atrial appendage
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Early safety (composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days)
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie
city: San Donato Milanese
country: Italy
facility: Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato
state: Milano
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Lisbon
country: Portugal
facility: Santa Maria University Hospital,
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: Inselspital Bern, Universitätsklinik für Kardiolgie
name: Lorenz Räber, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: