Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day

Recruiting Observational Study
Atrial Fibrillation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
678 (estimated)
Sponsor
Heart Rhythm Clinical and Research Solutions, LLC · Other
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About This Trial

SAFE HV is an observational, prospective, multi-center, non-randomized study evaluating real-world clinical experience of centers where a single procedural physician schedules eight or more left atrial appendage occlusion (LAAO) device implant procedures in a single calendar day.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older 2. Able and willing to participate in baseline and follow up evaluations for the full length of the study 3. Clinically qualified, in the opinion of the Investigator, to receive a LAAO device 4. Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO devi…
Contacts

Jennifer Moss

615-448-5770

safe@hrcrs.com

CONTACT

Carolyn Mills

205-807-0864

cmills@hrcrs.com

CONTACT