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

NCT06436924 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 678

Last updated 2025-10-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Left Atrial Appendage Device Implant

The Watchman Device is implanted into the left atrial appendage and is designed to close it off and keep blood clots from escaping that area.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Heart Rhythm Clinical and Research Solutions, LLC

    lead OTHER

Principal Investigators

  • Saumil Oza, MD · St. Vincent's

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-14
Primary Completion
2025-12-30
Completion
2026-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06436924 on ClinicalTrials.gov