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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Aortic Valve Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All study participants

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.

Group Type OTHER

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

Intervention Type DEVICE

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

Intervention Type DEVICE

LAA closure with the WATCHMAN device

Interventions

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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)

Intervention Type DEVICE

WATCHMAN

LAA closure with the WATCHMAN device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes