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RECRUITING
NCT06436924

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

Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

678

Start Date

2024-05-14

Completion Date

2026-03-30

Last Updated

2025-10-30

Healthy Volunteers

No

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.

Locations (7)

Grandview Medical Center

Birmingham, Alabama, United States

Pima Heart and Vascular

Tucson, Arizona, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Ascension St. Vincent

Jacksonville, Florida, United States

Naples Community Hospital

Naples, Florida, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Medical University of South Carolina

Columbia, South Carolina, United States