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RECRUITING

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

NCT06436924 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DEVICE Left Atrial Appendage Device Implant

Study Locations (7)

Florida

  • Ascension St. Vincent — Jacksonville
  • Naples Community Hospital — Naples

Alabama

  • Grandview Medical Center — Birmingham

Arizona

  • Pima Heart and Vascular — Tucson

Colorado

  • The Medical Center of Aurora — Aurora

Georgia

  • Memorial Health University Medical Center — Savannah

South Carolina

  • Medical University of South Carolina — Columbia

Trial Details

FieldValue
Enrollment Target 678 participants
Start Date 2024-05-14
Est. Completion 2026-03-30

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06436924

The ClinicalTrials.gov registry entry for NCT06436924 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 678 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Heart Rhythm Clinical and Research Solutions, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention — of which Left Atrial Appendage Device Implant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06436924 reports 7 study locations spanning 6 distinct geographic areas — top geographies include Florida, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06436924 about?

NCT06436924 is a clinical study titled "Safety and Efficacy of Workflows of High Volume Single Operators in a LAAO Device Implant Procedural Day". 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.

What is the current status of trial NCT06436924?

This trial is currently recruiting. The enrollment target is 678 participants. The study started on 2024-05-14. Estimated completion is 2026-03-30.

What conditions does trial NCT06436924 study?

This clinical trial studies the following conditions: Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06436924?

The interventions under investigation include: Left Atrial Appendage Device Implant (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06436924?

This trial is sponsored by Heart Rhythm Clinical and Research Solutions, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06436924 being conducted?

This trial has 7 study locations across Alabama, Arizona, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial