Comparison of Amplatzer Amulet and Watchman Device in Patients Undergoing Left Atrial Appendage Closure. (SWISS-APERO) (SWISS-APERO)

May 22, 2024 updated by: Insel Gruppe AG, University Hospital Bern

Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial

Left atrial appendage closure (LAAC) is an emerging therapeutic option in non-valvular atrial fibrillation (NVAF) patients with high thromboembolic and bleeding risks. In Europe the devices most frequently utilized for LAAC are Amplatzer Amulet (St. Jude Medical-Abbott) and Watchman (Boston Scientific) system. However there are currently no randomized controlled trials assessing the degree of LAA closure between the two devices. The main purpose of this trial is to evaluate the feasibility and the efficacy of the devices in terms of LAA complete occlusion with a non-invasive imaging technique such as cardiac computed tomography angiography (CCTA).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Non-valvular Atrial fibrillation (NVAF) is the most common cardiac arrhythmia and a major cause of morbidity and mortality because of cardioembolic stroke. Oral anticoagulation (OAC) with vitamin K antagonists (VKA) or Non-vitamin K antagonist anticoagulant (NOAC) is the most effective prophylaxis for stroke in NVAF. However (N)OAC therapy is associated with a significant bleeding liability and long-term (N)OAC therapy in patients with NVAF and concomitant high bleeding risk poses safety issues in a sizable and growing population in clinical practice. Thus, a new and emerging therapeutic option in this high-risk patient population is the left atrial appendage closure (LAAC). There are many available systems approved for percutaneous LAAC. One of the most widely used is the Watchman™ system (Boston Scientific), which was tested in the setting of two randomized control trials (RCT), which demonstrated the safety of the procedure and the non-inferiority in terms of stroke reduction compared to OAC. Another device largely used is the Amplatzer Amulet (St. Jude Medical-Abbott). There is no RCT comparing this device with OAC, but many prospective and retrospective studies had shown the same safety profile and the non-inferiority with the OAC. From the very beginning of the LAAC, a crucial assessment is the degree of LAA occlusion granted by the implanted device. Many imaging modalities have been used to assess LAA occlusion, including transesophageal echocardiography (TEE), fluoroscopy or cardiac computed tomography angiography (CCTA). In the setting of available randomized trials, successful closure was defined with the presence of a regurgitant flow ≤ 5 mm assessed with TEE. In the last years several groups assessed the value of CCTA as non-invasive post-procedural surveillance imaging modality after endovascular LAAC to evaluate atrial-side device thrombus, residual leak (and mechanisms thereof), device position, pericardial effusion and most importantly LAA patency. There are currently no randomized controlled trials assessing the degree of LAA occlusion between Amulet and Watchman.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Belgium
      • Charleroi, Belgium, 6000
        • Centre Hospitalier Universitaire de Charleroi
  • France
      • Besançon, France, 25030
        • Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz
      • Bordeaux, France, 33600
        • Hopital cardiologique Haut Lévêque CHU de Bordeaux
      • Créteil, France, 94010
        • Hôpital Hôpitaux Universitaires Henri-Mondor
      • Rouen, France, 76000
        • Centre Hospitalier Universitaire Hôpitaux de Rouen
  • Italy
      • Milano, Italy, 20097
        • IRCCS Policlinico S.Donato
  • Switzerland
      • Lugano, Switzerland, 6900
        • Department of Cardiology, Cardiocentro Ticino
    • Switzerland/Bern
      • Bern, Switzerland/Bern, Switzerland, 3010
        • Bern University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Written informed consent
  • Male or female subject aged 18 years or more with no upper age limit and willing to comply with the protocol
  • Indication to a LAAC as indicated in study population (HAS BLEED ≥3 or High bleeding risk as defined by Munich consensus document and CHA2DS2-VASc≥2)

Exclusion Criteria:

  • New York Heart Association class IV congestive heart failure
  • Atrial septal defect or atrial septal repair or closure device
  • Single occurrence of atrial fibrillation
  • Cardioversion or ablation procedure planned within 30 days
  • Implanted mechanical valve prosthesis
  • Heart transplantation
  • Enrolled in another IDE or IND investigation of a cardiovascular device or an investigational drug
  • Pregnant or pregnancy is planned during the course of the investigation
  • Active infection of any kind
  • Severe chronic kidney insufficiency (CrCl< 30 ml/min)
  • Terminal illness with life expectancy < 1 yr
  • Echocardiographic exclusion criteria
  • Left ventricular ejection fraction < 20%
  • Intra-cardiac thrombus or dense spontaneous echo contrast as visualized by TEE within 2 days before implant
  • Significant mitral valve stenosis (ie, MV <1.5 cm2)
  • Complex aortic atheroma with mobile plaque of the descending aorta and/or aortic arch
  • Cardiac tumor

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Amplatzer Amulet
Left atrial appendage closure (LAAC) with Amplatzer Amulet implantation will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.
Device: Amplatzer Amulet for left atrial appendage closure
The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Amplatzer Amulet will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.
Active Comparator: Watchman/FLX
Left atrial appendage closure (LAAC) with Watchman/FLX implantation will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.
Device: Watchman/FLX for left atrial appendage closure
The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Watchman/FLX will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Composite of left atrial appendage (LAA) patency at 45 day evaluated with cardiac computed tomography angiography (CCTA) or the crossover from one device to the other device based on morphological/anatomical considerations during device implantation
Time Frame: 45 days
Composite endpoint
45 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All cause of death, stroke, systemic or pulmonary embolism and spontaneous myocardial infarction
Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Composite endpoint
48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
LAA patency at 45-day and 13-month CCTA in the per protocol and as treated populations
Time Frame: 45 days and 13 months
LAA patency (arterial and/or venous phase) at 45-day and 13-month CCTA in the per protocol and as treated populations
45 days and 13 months
Cardiovascular death
Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Cardiovascular death
48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Ischemic stroke
Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Ischemic stroke
48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Haemorrhagic stroke
Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Haemorrhagic stroke
48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Bleeding events according to the BARC classification at each follow up
Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Bleeding events according to the BARC classification at each follow up
48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Procedure-related complications
Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Procedure-related complications
48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years
Rate of patients on (N)OAC at 45 days and 6 months
Time Frame: 45 days and 6 months
Rate of patients on (N)OAC at 45 days and 6 months
45 days and 6 months
Device thrombosis
Time Frame: 45 days and 13 months
Device related thrombosis at 45 day TEE/CCTA and 13-month CCTA in the per protocol and as treated populations
45 days and 13 months
Number of device implantation attempts
Time Frame: end of procedure
Number of device implantation attempts
end of procedure
Total time procedure
Time Frame: end of procedure
Total time procedure (minutes)
end of procedure
x-ray dose
Time Frame: end of procedure
x-ray dose (cGy.cm2)
end of procedure
fluoroscopy duration
Time Frame: end of procedure
fluoroscopy duration (minutes)
end of procedure
amount of contrast used during the procedure
Time Frame: end of procedure
amount of contrast used during the procedure (ml)
end of procedure
LAA patency
Time Frame: 45 days
LAA patency at 45 day by TEE in the per protocol and as treated populations
45 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marco Valgimigli, Prof, Fondazione Cardiocentro Ticino
  • Principal Investigator: Emmanuel Teiger, Prof, Hôpital Hôpitaux Universitaires Henri-Mondor
  • Principal Investigator: Nicolas Meneveau, Prof, Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz
  • Principal Investigator: Frederic Anselme, Prof, Centre Hospitalier Universitaire Hôpitaux de Rouen
  • Study Chair: Lorenz Räber, Prof, Inselspital, Bern University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SWISS-APERO

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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