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

Primary Purpose

Aortic Valve Disorder

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
WATCHMAN
Sponsored by
Insel Gruppe AG, University Hospital Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disorder focused on measuring Aortic Valve Stenosis, Left atrial appendage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie
  • Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato
  • Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "
  • Azienda Ospedaliero Universitaria Pisana
  • Santa Maria University Hospital,
  • Inselspital Bern

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All study participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 28, 2016
Last Updated
February 21, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
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1. Study Identification

Unique Protocol Identification Number
NCT02678871
Brief Title
Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Acronym
TAVI-LAAC
Official Title
Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Device was withdrawn from the market
Study Start Date
March 8, 2017 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disorder
Keywords
Aortic Valve Stenosis, Left atrial appendage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All study participants
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
Intervention Description
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
Intervention Name(s)
WATCHMAN
Intervention Description
LAA closure with the WATCHMAN device
Primary Outcome Measure Information:
Title
Early safety (composite endpoint of TAVI-related (according to VARC 2 criteria) and percutaneous LAA closure-related events at 30 days)
Description
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
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenz Räber, Prof. Dr.
Organizational Affiliation
Inselspital Bern, Universitätsklinik für Kardiolgie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Santa Maria University Hospital,
City
Lisbon
ZIP/Postal Code
1649-028
Country
Portugal
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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