RECRUITING

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

Talk to us

Conditions

Atrial Fibrillation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-05-30
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06436924

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age or older
  2. 2. Able and willing to participate in baseline and follow up evaluations for the full length of the study
  3. 3. Clinically qualified, in the opinion of the Investigator, to receive a LAAO device
  4. 4. Receiving a Watchman FLX™ or Watchman FLX Pro™ LAAO device as part of their plan of care
  5. 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
  6. 6. Willing and able to provide informed consent
  1. 1. Enrolled in an investigational drug or device clinical trial, or any trial that dictates the treatment plan
  2. 2. In the opinion of the Investigator, any known contraindication to a LAAO device or implant procedure
  3. 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

Contacts and Locations

Study Contact

Lynn Landborg
CONTACT
763-381-9135
safe@hrcrs.com
Carolyn Mills
CONTACT
205-807-0864
cmills@hrcrs.com

Principal Investigator

Saumil Oza, MD
PRINCIPAL_INVESTIGATOR
St. Vincent's

Study Locations (Sites)

Memorial Health University Medical Center
Savannah, Georgia, 31404
United States

Collaborators and Investigators

Sponsor: Heart Rhythm Clinical and Research Solutions, LLC

  • Saumil Oza, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-05-30
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-05-30
Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation