Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399851
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Left Atrial Appendage Closure Device: Amplatzer Amulet for left atrial appendage closure Device: Watchman/FLX for left atrial appendage closure Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure: the SWISS-APERO Randomized Clinical Trial
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Cardiovascular death [ Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years ]
    Cardiovascular death

  4. Ischemic stroke [ Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years ]
    Ischemic stroke

  5. Haemorrhagic stroke [ Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years ]
    Haemorrhagic stroke

  6. 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

  7. Procedure-related complications [ Time Frame: 48 hours, 45 days, 1 year, 2 years, 3 years, 4 years and 5 years ]
    Procedure-related complications

  8. 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

  9. 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

  10. Number of device implantation attempts [ Time Frame: end of procedure ]
    Number of device implantation attempts

  11. Total time procedure [ Time Frame: end of procedure ]
    Total time procedure (minutes)

  12. x-ray dose [ Time Frame: end of procedure ]
    x-ray dose (cGy.cm2)

  13. fluoroscopy duration [ Time Frame: end of procedure ]
    fluoroscopy duration (minutes)

  14. amount of contrast used during the procedure [ Time Frame: end of procedure ]
    amount of contrast used during the procedure (ml)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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≥4)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399851


Contacts
Layout table for location contacts
Contact: Marco Valgimigli, Prof +41 316329653 marco.valgimigli@insel.ch

Locations
Layout table for location information
Belgium
Centre Hospitalier Universitaire de Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Adel Aminian, Dr.         
France
Centre Hospitalier Régional Universitaire Hôpital Jean Minjoz Recruiting
Besançon, France, 25030
Contact: Nicolas Meneveau, Prof         
Hopital cardiologique Haut Lévêque CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33600
Contact: Xavier Iriart, Dr.         
Hôpital Hôpitaux Universitaires Henri-Mondor Recruiting
Créteil, France, 94010
Contact: Emmanuel Teiger, Prof         
Centre Hospitalier Universitaire Hôpitaux De Rouen Recruiting
Rouen, France, 76000
Contact: Frederic Anselme, Prof         
Italy
IRCCS Policlinico S.Donato Recruiting
Milano, Italy, 20097
Contact: Federico De Marco, Dr.         
Switzerland
Bern University Hospital Recruiting
Bern, Switzerland/Bern, Switzerland, 3010
Contact: Marco Valgimigli, Prof    +41 316329653    marco.valgimigli@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Layout table for investigator information
Study Chair: Marco Valgimigli, Prof Inselspital, Bern University Hospital
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
Layout table for additonal information
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03399851    
Other Study ID Numbers: SWISS-APERO
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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