- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678871
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
Status
Terminated
Conditions
Intervention / Treatment
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
- Name: Lorenz Räber, Prof. Dr.
- Phone Number: +41 31 632 21 11
- Email: lorenz.raeber@insel.ch
Study Locations
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Rostock, Germany, 18057
- Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie
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Catania, Italy, 95123
- Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "
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Pisa, Italy, 56126
- Azienda Ospedaliero Universitaria Pisana
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Milano
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San Donato Milanese, Milano, Italy, 20097
- Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato
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Lisbon, Portugal, 1649-028
- Santa Maria University Hospital,
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Bern, Switzerland, 3010
- Inselspital Bern
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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 |
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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.
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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
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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
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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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30 Days
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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
Additional Relevant MeSH Terms
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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