## Protocol Section
### Identification Module
**NCT ID:** NCT06436924

**Brief Title:** Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural 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

#### Organization Study ID Info
**ID:** SAFE HV
#### Organization
**Class:** OTHER
**Full Name:** Heart Rhythm Clinical and Research Solutions, LLC
### Status Module
#### Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-09-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Boston Scientific Corporation

#### Lead Sponsor

**Class:** OTHER

**Name:** Heart Rhythm Clinical and Research Solutions, LLC

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Atrial Fibrillation

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 678

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Watchman LAAO device implant

**Intervention Names:**

- Device: Left Atrial Appendage Device Implant

**Label:** Subjects undergoing LAAO device implant

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Subjects undergoing LAAO device implant

**Description:** 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.

**Name:** Left Atrial Appendage Device Implant

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Incidence of peri-procedural complications summarized descriptively and compared to historical data

**Measure:** Peri-procedural complications

**Time Frame:** Procedure through discharge, an average of 1-3 days

**Description:** 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.

**Measure:** Peri-device leakage

**Time Frame:** Date of implant up to 90 days

**Description:** Incidence of post procedure complications summarized descriptively and compared to historical data.

**Measure:** Late onset complications

**Time Frame:** Discharge to 30 days.

### Eligibility Module

**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 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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).

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** safe@hrcrs.com

**Name:** Lynn Landborg

**Phone:** 763-381-9135

**Role:** CONTACT

**Contact 2:**

**Email:** cmills@hrcrs.com

**Name:** Carolyn Mills

**Phone:** 205-807-0864

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Savannah

**Contacts:**

***Contact 1:***

- **Email:** lindsey.lamb@hcahealthcare.com

- **Name:** Lindsey Lamb, MHSA

- **Phone:** 912-350-9032

- **Role:** CONTACT

***Contact 2:***

- **Email:** RitzieAnne.trinidad@hcahealthcare.com

- **Name:** Ritzie A Trinidad, MBA

- **Phone:** 912-350-3110

- **Role:** CONTACT

***Contact 3:***

- **Name:** Todd Senn, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** David Newton, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Memorial Health University Medical Center

**State:** Georgia

**Status:** RECRUITING

**Zip:** 31404

#### Overall Officials

**Official 1:**

**Affiliation:** St. Vincent's

**Name:** Saumil Oza, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Atrial Fibrillation

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

### Misc Info Module

- Version Holder: 2024-05-31
