Atrial FibrillationNCT06436924
Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day
An observational study of Atrial Fibrillation, run by Heart Rhythm Clinical and Research Solutions, LLC at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Left Atrial Appendage Device Implant
- Type of treatment
- Medical device
- How many people
- 569 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 May 2024to 19 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the study
- Clinically qualified, in the opinion of the Investigator, to receive a LAAO device
- Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care
- 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
- Willing and able to provide informed consent
Who cannot join
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Medical Center of Aurora
Aurora, Colorado, 80012
Grandview Medical Center
Birmingham, Alabama, 35243
Medical University of South Carolina
Columbia, South Carolina, 29204
Ascension St. Vincent
Jacksonville, Florida, 32204
Naples Community Hospital
Naples, Florida, 34102
Memorial Health University Medical Center
Savannah, Georgia, 31404
Pima Heart and Vascular
Tucson, Arizona, 85704
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Left Atrial Appendage Device Implant
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Atrial Appendage Device ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects undergoing LAAO device implant | Watchman LAAO device implant Receives: Device: Left Atrial Appendage Device Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-procedural complications
Incidence of peri-procedural complications summarized descriptively and compared to historical data
Measured: Procedure through discharge, an average of 1-3 days
Peri-device leakage
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.
Measured: Date of implant up to 90 days
Late onset complications
Incidence of post procedure complications summarized descriptively and compared to historical data.
Measured: Discharge to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start14 May 2024
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Saumil Oza, MD, Principal investigator, St. Vincent's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436924
- Sponsor's protocol ID
- SAFE HV
- Status last verified
- Jun 2026
- First submitted
- 22 May 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Workflows of High Volume Single Operators in a Left Atrial Appendage Occlusion Device Implant Procedural Day: SAFE HV
- ClinicalTrials.gov ID
- NCT06436924
- Acronym / sponsor ID
- SAFE HV
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- Heart Rhythm Clinical and Research Solutions, LLCUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 14 May 2024 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects undergoing LAAO device implant | – | Device: Left Atrial Appendage Device ImplantWatchman LAAO device implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 18 years of age or older
- Able and willing to participate in baseline and follow up evaluations for the full length of the study
- Clinically qualified, in the opinion of the Investigator, to receive a LAAO device
- Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care
- 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
Key exclusion criteria (3 listed)
- Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
- In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left Atrial Appendage Device ImplantThe Watchman Device is implanted into the left atrial appendage and is designed to close it off and keep blood clots from escaping that area. | Device | Subjects undergoing LAAO device implant |
Primary outcome
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
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.
Late onset complications
Time frame: Discharge to 30 days.
Incidence of post procedure complications summarized descriptively and compared to historical data.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saumil Oza, MD principal investigator
St. Vincent's
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Heart Rhythm Clinical and Research Solutions, LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-procedural complications (time frame: Procedure through discharge, an average of 1-3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.