Registry on WATCHMAN Outcomes in Real-Life Utilization (EWOLUTION)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01972282
First received: October 24, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Registry on WATCHMAN Outcomes in Real-Life Utilization

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Procedural complications [ Time Frame: At Implant ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 2 year follow-up ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 2 year follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: October 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with non-valvular atrial fibrillation

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972282

Contacts
Contact: Elke Sommerijns elke.sommerijns@bsci.com
Contact: Kirsten Welz +49 2429 903937 welzk@bsci.com

  Show 52 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01972282     History of Changes
Other Study ID Numbers: 90875647
Study First Received: October 24, 2013
Last Updated: July 15, 2014
Health Authority: Belgium: Institutional Review Board
Czech Republic: Ethics Committee
France: French Data Protection Authority
France: The Commission nationale de l’informatique et des libertés
Germany: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Portugal: Data Protection Agency
Portugal: Ethics Committee for Clinical Research
Spain: Ethics Committee

Keywords provided by Boston Scientific Corporation:
Atrial fibrillation
Stroke
Thrombus
Thromboembolism
Left atrial appendage

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Thromboembolism
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on July 22, 2014