Recruiting

Observational Study

Sponsor:

Cardiology Research UBC

Code:

NCT02533752

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Canadian WATCHMAN Registry is a multicentre (8 Centres) Canadian prospective, non-randomized, registry to enrol 100 consecutive patients undergoing LAA closure with the WATCHAN device to study the safety and effectiveness of the WATCHMAN device

Conditions

Atrial Fibrillation

Study ID

NCT02533752

Start date

Sep, 2014

Status verified date

Aug, 2018

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years, and
  • CHADS2 ≥1 and/or CHADS-VASc ≥2, and
  • Prior major bleeding (intracranial, gastrointestinal bleeding, intraocular, respiratory, genitourinary, retroperitoneal, pericardial, anemia requiring transfusions, etc.), or contraindications to long-term OAC (HASBLED ≥3, high fall risk, cerebral aneurysm, blood dyscrasias, aortic dissection, etc.), or failure of OAC (stroke/TIA while on OAC)

Exclusion Criteria:

  • Presence of LAA thrombus
  • Severe untreated mitral stenosis (no prior valve replacement)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Main Group

This an observational registry - there is only one group

Primary outcome measure

  • Major Adverse Events [ Time Frame: From up to 24 Months from procedure ]

Central Contacts and Locations

Central contacts

Jacqueline Saw, MD

604 875 5547jsaw@mail.ubc.ca

Andrew Starovoytov, MD

604 875 5079a.starovoytov@ubc.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

Andrew Sytarovoytov, MD

604 875 5079a.starovoytov@ubc.ca

More Information

Sponsor

Cardiology Research UBC

Last update posted

Aug 10, 2018

Last verified

Aug, 2018

Keywords

  • Left Atrial Appendage Closure
  • Watchman device
  • LAA Closure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiology Research UBC on 2018-08-10.