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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678871
Recruitment Status : Recruiting
First Posted : February 10, 2016
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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 WATCHAMN 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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disorder Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations) Device: WATCHMAN Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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)

Device: WATCHMAN
LAA closure with the WATCHMAN device




Primary Outcome Measures :
  1. Early safety (composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678871


Contacts
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Contact: Lorenz Räber, Prof. Dr. +41 31 632 21 11 lorenz.raeber@insel.ch

Locations
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Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Lorenz Räber, Prof. Dr.    +4131 632 21 11    lorenz.raeber@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Lorenz Räber, Prof. Dr. Inselspital Bern, Universitätsklinik für Kardiolgie
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT02678871    
Other Study ID Numbers: 2016-01-18
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Aortic Valve Stenosis
Left atrial appendage