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

October 29, 2025 updated by: Heart Rhythm Clinical and Research Solutions, LLC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Since 2009, Watchman FLX™ and its predecessor, Watchman™ have provided a safe and effective alternative to oral anticoagulation for over 200,000 patients in the United States and Europe. Advancements in the design of the Watchman FLX™ have made the device available to a wider range of patients. As more patients qualify for the device, more implant procedures are necessary to provide them with this life-changing treatment option.

Some Watchman FLX™ implanters perform high volumes of implant procedures on certain days. While performing a high-volume of implant procedures is desirable for many reasons, it must be determined that cases performed under such circumstances are comparable in safety and efficacy to implant procedures performed at lower volumes. While there has been no differentiation between high and low volume cases in previous studies, data obtained in this study will be compared to overall safety and efficacy data available from the PINNACLE FLX clinical trial and the SURPASS analysis to ensure that safety and efficacy outcomes are comparable.

Additionally, this study will collect data on the workflows of these high-volume implanters that will help determine which factors contribute to the successful performance of high volumes of Watchman FLX™ implants in a single day. In the future this information may be used to help other implanters optimize workflows to increase their volume of daily implants and hence, provide more opportunities for patients to access this transformative device.

Study Type

Observational

Enrollment (Estimated)

678

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jennifer Moss
  • Phone Number: 615-448-5770
  • Email: safe@hrcrs.com

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35243
        • Recruiting
        • Grandview Medical Center
        • Principal Investigator:
          • Anil Rajendra, MD
        • Contact:
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Pima Heart and Vascular
        • Principal Investigator:
          • Thomas Waggoner, MD
        • Contact:
          • Monica Varela
          • Phone Number: 520-838-3540
        • Contact:
          • Aleksander Herber
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • The Medical Center of Aurora
        • Principal Investigator:
          • Christopher Porterfield, MD
        • Contact:
          • Chris Dutka, Research Coordinator
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Recruiting
        • Ascension St. Vincent
        • Principal Investigator:
          • Anthony Magnano, MD
        • Contact:
      • Naples, Florida, United States, 34102
        • Recruiting
        • Naples Community Hospital
        • Contact:
          • Kathy Byrd
          • Phone Number: 239-624-4200
        • Principal Investigator:
          • Dinesh Sharma, M.D.
    • Georgia
      • Savannah, Georgia, United States, 31404
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • Medical University of South Carolina
        • Contact:
          • Jacqueline Sheriod-Scott
          • Phone Number: 803-409-7175
        • Contact:
          • Barbara Burrell
        • Principal Investigator:
          • Loren Morgan, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will include subjects who are clinically qualified for a Watchman FLX™ or Watchman FLX Pro™ LAAO device implant and would receive one regardless of participation in the study, who meet all eligibility criteria for the study, and present at participating institutions for a LAAO device implant procedure on a day in which a single implanting physician scheduled at least eight LAAO device implant procedures, regardless of the device manufacturer (i.e., high-volume).

Description

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 device as part of their plan of care

  5. Having their LAAO device implant procedure scheduled on a qualifying high-volume* procedure day as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date

    *high-volume - a calendar day in which the single implanting physician schedules ≥ 8 LAAO device implant procedures, regardless of the device manufacturer

  6. Willing and able to provide informed consent

Exclusion Criteria:

  1. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
  2. In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
  3. Having their LAAO device implant procedure scheduled on a day in which the single implanting physician scheduled < 8 LAAO device implant procedures as assessed within 2 days (≤ 2 calendar days) prior to the planned procedure date

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects undergoing LAAO device implant
Watchman LAAO device implant
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-procedural complications
Time Frame: Procedure through discharge, an average of 1-3 days
Incidence of peri-procedural complications summarized descriptively and compared to historical data
Procedure through discharge, an average of 1-3 days
Peri-device leakage
Time Frame: Date of implant up to 90 days
Assessed by successful closure of the left atrial appendage defined by peri-device leakage of <5mm. This will be identified at the post implant imaging.
Date of implant up to 90 days
Late onset complications
Time Frame: Discharge to 30 days.
Incidence of post procedure complications summarized descriptively and compared to historical data.
Discharge to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Rhythm Clinical and Research Solutions, LLC

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Saumil Oza, MD, St. Vincent's

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAFE HV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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