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

February 21, 2023 updated by: University Hospital Inselspital, Berne
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Rostock, Germany, 18057
        • Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie
      • Catania, Italy, 95123
        • Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
    • Milano
      • San Donato Milanese, Milano, Italy, 20097
        • Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato
      • Lisbon, Portugal, 1649-028
        • Santa Maria University Hospital,
      • Bern, Switzerland, 3010
        • Inselspital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Patients meeting clinical and anatomical pre-requisites will undergo TAVI with the Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
LAA closure with the WATCHMAN device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lorenz Räber, Prof. Dr., Inselspital Bern, Universitätsklinik für Kardiolgie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2017

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

February 5, 2016

First Posted (Estimate)

February 10, 2016

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-01-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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