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

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ClinicalTrials.gov Identifier: NCT01972282
Recruitment Status : Unknown
Verified January 2016 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2013
Last Update Posted : January 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

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

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.


Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 1021 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Registry on WATCHMAN Outcomes in Real-Life Utilization
Study Start Date : October 2013
Primary Completion Date : November 2015
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Procedural complications [ Time Frame: At Implant ]
  2. Stroke [ Time Frame: 2 year follow-up ]
  3. Death [ Time Frame: 2 year follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01972282


  Show 53 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01972282     History of Changes
Other Study ID Numbers: 90875647
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016

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

Additional relevant MeSH terms:
Atrial Fibrillation
Thromboembolism
Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases