Aortic Valve DisorderTAVI-LAACNCT02678871
Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
A study testing Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations) and WATCHMAN in people with Aortic Valve Disorder, run by Insel Gruppe AG, University Hospital Bern at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Valve Disorder
- What is being tested?
- Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations) and WATCHMAN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 8 Mar 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Written informed consent
- Aortic annulus size ≥ 20 mm and ≤ 27 mm
- Adequate LAA ostium diameter (17 31mm)
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Italy3 sites
Azienda Ospedaliera Universitaria Policlinico "G.Rodolico "
Catania, 95123
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
Structural Heart Disease Interventions Unit - IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097
Germany1 site
Universitätsmedizin Rostock Zentrum für Innere Medizin Abteilung für Kardiologie
Rostock, 18057
About this study
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.
- Conditions
- Aortic Valve Disorder
- Being tested
- Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations), WATCHMAN
- Keywords
- Aortic Valve Stenosis, Left atrial appendage
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)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)
WATCHMANDevice
LAA closure with the WATCHMAN device
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Other | 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. Receives: Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations); Device: WATCHMAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start8 Mar 2017
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Why it stopped: Device was withdrawn from the market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DisorderStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenz Räber, Prof. Dr., Principal investigator, Inselspital Bern, Universitätsklinik für Kardiolgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678871
- Sponsor's protocol ID
- 2016-01-18
- Acronym
- TAVI-LAAC
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2016
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Transcatheter Aortic Valve Implantation and Percutaneous Closure of the Left Atrial Appendage
- ClinicalTrials.gov ID
- NCT02678871
- Acronym / sponsor ID
- TAVI-LAAC / 2016-01-18
- Conditions
- Aortic Valve Disorder
- Keywords
- Aortic Valve Stenosis, Left atrial appendage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device was withdrawn from the market
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | Other | Device: Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations), Device: WATCHMANPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | All study participants |
| WATCHMANLAA closure with the WATCHMAN device | Device | All study participants |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Device was withdrawn from the market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenz Räber, Prof. Dr. principal investigator
Inselspital Bern, Universitätsklinik für Kardiolgie
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations) and WATCHMAN in people with Aortic Valve Disorder, run by Insel Gruppe AG, University Hospital Bern at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Germany, Portugal, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Device was withdrawn from the market). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.