Clinical trial NCT01972282: Registry on WATCHMAN Outcomes in Real-Life Utilization
Official title: Registry on WATCHMAN Outcomes in Real-Life Utilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke
Keywords: Atrial fibrillation
Stroke
Thrombus
Thromboembolism
Left atrial appendage
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-10-30
Enrollment: 1025
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation

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.

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.

Primary outcomes:
measure: Procedural Complications
timeFrame: 7 days post-implant
measure: Ischemic Stroke
timeFrame: 2 year follow-up
measure: Death
timeFrame: 2 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Bordeaux
country: France
facility: Hospitaux du Haut Leveque
city: Creteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: University Hospital
city: Lille
country: France
facility: CHRU Lille
city: Marseille
country: France
facility: CHU La Timone Hospital
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Paris
country: France
facility: Groupe hospitalier Bichat Claude Bernard
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin - Campus Virchow Klinikum - Medizinische Klinik fur Kardiologie
city: Berlin
country: Germany
facility: Vivantes Klinikum Am Urban
city: Berlin
country: Germany
facility: Vivantes Klinikum im Friedrichshain
city: Bielefeld
country: Germany
facility: Evangelisches Krankenhaus
city: Bonn
country: Germany
facility: Universitatklinikum Medizinische
city: Duesseldorf
country: Germany
facility: Dominikus-Krankenhaus
city: Essen
country: Germany
facility: Elisabeth Krankenhaus
city: Frankfurt
country: Germany
facility: Cardio Vasculares Centrum Sankt Katharinen
city: Frankfurt
country: Germany
facility: Cardioangiologisches Centrum Bethanien
city: Greifswald
country: Germany
facility: Univeritatsmedizin Greifswald
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
city: Hamburg
country: Germany
facility: Aklepios Klinik St Georg
city: Leipzig
country: Germany
facility: Universitatklinikum Leipzig
city: Mainz
country: Germany
facility: Universitatsmedizin Mainz
city: Munich
country: Germany
facility: Stadtisches Klinikum Neuperlach
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Bruder
city: Weissenfels
country: Germany
facility: Asklepios Klinik Weissenfels
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Catania
country: Italy
facility: Ospedale Ferrarotto Alessi
city: Cirie
country: Italy
facility: ASL TO 4 Ospedale di Cirie
city: Milan
country: Italy
facility: Ospedale San Raffaele
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore "Don Calabria"
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum Rotterdam
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 1im dr A Jurasza
city: Poznan
country: Poland
facility: Clinical Hospital University of Medicine
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Krasnoyarsk
country: Russian Federation
facility: Regional Vascular Center
city: Moscow
country: Russian Federation
facility: State Cardiology Research Center
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
city: Riyadh
country: Saudi Arabia
facility: King Fahed Medical City - Prince Salman Cardiac Center
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: Sharjah
country: United Arab Emirates
facility: Al Qassimi Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospita
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Trust
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
affiliation: St. Antonius Hospital
name: Lucas VA Boersma
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.