Registry on WATCHMAN Outcomes in Real-Life Utilization

NCT ID: NCT01972282

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1025 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-28
• Study Completion Date: 2018-01-04

Brief Summary

The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

Detailed Description

Approximately 1000 subjects will be enrolled in the study. To reduce the impact of individual center bias, each site may include up to 45 subjects and each country may include a maximum of 500 patients. Up to 70 sites (international, outside of US) will participate in the study.

Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the study.

Each patient will be followed for a period of two years after enrollment according to the schedule and standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects who participate in the study. Subjects are expected to be followed at implant, then at one post-implant visit (typically between 1-3 months of implant), and then annually through 2 years post implant. An intermediate visit may be scheduled in a number of patients, per physician discretion. In order to reliably capture patient status at study end, a follow-up window of 24 +/- 3 months will be considered acceptable for scheduling the last visit.

For subjects who are not scheduled to visit the clinic for a follow-up, a subject contact (e.g. phone call) will ensure capture of the endpoint related information; however, it is recommended to perform an in-office visit for at least the first annual visit.

Enrollment is expected to be completed in 21 months; therefore, the total study duration is estimated to be 48 months.

Conditions

Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

WATCHMAN Left Atrial Appendage Closure

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who are eligible for a WATCHMAN device according to current international and local guidelines (and future revisions) and per physician discretion;
• Patient who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational center;
• Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria

• Patient who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility;
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
• The subject is unable or not willing to complete follow-up visits and examination for the duration of the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lucas VA Boersma

Role: PRINCIPAL_INVESTIGATOR

St. Antonius Hospital

Locations

OLV Ziekenhuis

Aalst, , Belgium

Hospitaux du Haut Leveque

Bordeaux, , France

CHU Henri Mondor

Créteil, , France

University Hospital

Grenoble, , France

CHRU Lille

Lille, , France

CHU La Timone Hospital

Marseille, , France

Nouvelles Cliniques Nantaises

Nantes, , France

Groupe hospitalier Bichat Claude Bernard

Paris, , France

Charite Universitatsmedizin Berlin - Campus Virchow Klinikum - Medizinische Klinik fur Kardiologie

Berlin, , Germany

Vivantes Klinikum Am Urban

Berlin, , Germany

Vivantes Klinikum im Friedrichshain

Berlin, , Germany

Evangelisches Krankenhaus

Bielefeld, , Germany

Universitatklinikum Medizinische

Bonn, , Germany

Dominikus-Krankenhaus

Düsseldorf, , Germany

Elisabeth Krankenhaus

Essen, , Germany

Cardio Vasculares Centrum Sankt Katharinen

Frankfurt, , Germany

Cardioangiologisches Centrum Bethanien

Frankfurt, , Germany

Univeritatsmedizin Greifswald

Greifswald, , Germany

Cardiologicum Hamburg

Hamburg, , Germany

Aklepios Klinik St Georg

Hamburg, , Germany

Universitatklinikum Leipzig

Leipzig, , Germany

Universitatsmedizin Mainz

Mainz, , Germany

Stadtisches Klinikum Neuperlach

Munich, , Germany

Krankenhaus Barmherzige Bruder

Regensburg, , Germany

Asklepios Klinik Weissenfels

Weißenfels, , Germany

Beaumont Hospital

Dublin, , Ireland

Ospedale Ferrarotto Alessi

Catania, , Italy

ASL TO 4 Ospedale di Cirie

Cirié, , Italy

Ospedale San Raffaele

Milan, , Italy

Ospedale Sacro Cuore "Don Calabria"

Negrar, , Italy

Medisch Spectrum Twente

Enschede, , Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, , Netherlands

St. Antonius Hospital

Nieuwegein, , Netherlands

Erasmus Medisch Centrum Rotterdam

Rotterdam, , Netherlands

Szpital Uniwersytecki nr 1im dr A Jurasza

Bydgoszcz, , Poland

Clinical Hospital University of Medicine

Poznan, , Poland

Hospital de Santa Maria

Lisbon, , Portugal

Regional Vascular Center

Krasnoyarsk, , Russia

State Cardiology Research Center

Moscow, , Russia

State Research Institute of Circulation Pathology

Novosibirsk, , Russia

King Fahed Medical City - Prince Salman Cardiac Center

Riyadh, , Saudi Arabia

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Al Qassimi Hospital

Sharjah city, , United Arab Emirates

Royal Victoria Hospita

Belfast, , United Kingdom

Royal Brompton & Harefield NHS Trust

London, , United Kingdom

Freeman Hospital

Newcastle, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Countries

Belgium; France; Germany; Ireland; Italy; Netherlands; Poland; Portugal; Russia; Saudi Arabia; Spain; United Arab Emirates; United Kingdom

References

Aarnink EW, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Mazzone P, Grygier M, Sievert H, De Potter T, Vireca E, Stein K, Bergmann MW, Boersma LVA. Incidence and predictors of 2-year mortality following percutaneous left atrial appendage occlusion in the EWOLUTION trial. Europace. 2024 Jul 2;26(7):euae188. doi: 10.1093/europace/euae188.

Reference Type: DERIVED

PMID: 39082730 (View on PubMed)

Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, Gori T, Meincke F, Protopopov AV, Betts T, Mazzone P, Foley D, Grygier M, Sievert H, De Potter T, Vireca E, Stein K, Bergmann MW; following investigators and institutions participated in the EWOLUTION study. Evaluating Real-World Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology: Final 2-Year Outcome Data of the EWOLUTION Trial Focusing on History of Stroke and Hemorrhage. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006841. doi: 10.1161/CIRCEP.118.006841.

Reference Type: DERIVED

PMID: 30939908 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

90875647

Identifier Type: OTHER

Identifier Source: secondary_id

EWOLUTION

Identifier Type: -

Identifier Source: org_study_id