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The CONFORM Pivotal Trial
NCT05147792 · View on ClinicalTrials.gov ↗
Study Summary
The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the CLAAS device or the WATCHMAN or Amulet™ devices and will be followed for 5 years after device implant.
Conditions Studied
Interventions
- DEVICE CLAAS
- DEVICE WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder
Study Locations (20)
Florida
- Ascension St. Vincent's Jacksonville — Jacksonville
- Largo Medical Center — Largo
- Baptist Hospital of Miami — Miami
- AdventHealth Orlando — Orlando
- Baptist Health Care - Pensacola — Pensacola
- Sarasota Memorial Health Care System — Sarasota
- AdventHealth Tampa — Tampa
- USF - Tampa General Hospital — Tampa
Arizona
- Banner University Medical Center Phoenix — Phoenix
- Abrazo Arizona Heart Hospital — Phoenix
- HonorHealth — Scottsdale
- Pima Heart & Vascular — Tucson
California
- Loma Linda University Health — Loma Linda
- Huntington Hospital — Pasadena
- Pacific Heart Institute — Santa Monica
- Community Memorial Hospital Ventura — Ventura
Alabama
- Grandview Medical Center — Birmingham
Arkansas
- St. Bernard's Medical Center — Jonesboro
Connecticut
- Hartford Health Care St. Vincent's Medical Center — Bridgeport
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,600 participants |
| Start Date | 2022-05-26 |
| Est. Completion | 2031-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05147792
The ClinicalTrials.gov registry entry for NCT05147792 describes a study currently listed as recruiting. It is categorized as NA, 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 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Conformal Medical, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions — of which CLAAS 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: NCT05147792 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, California. 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 NCT05147792 about?
NCT05147792 is a clinical study titled "The CONFORM Pivotal Trial". The CLAAS® device will be evaluated for safety and efficacy by establishing its performance is non-inferior to the commercially available WATCHMAN® and Amulet™ left atrial appendage closure devices in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be ran...
What is the current status of trial NCT05147792?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,600 participants. The study started on 2022-05-26. Estimated completion is 2031-12.
What conditions does trial NCT05147792 study?
This clinical trial studies the following conditions: Stroke, 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 NCT05147792?
The interventions under investigation include: CLAAS (DEVICE), WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05147792?
This trial is sponsored by Conformal Medical, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05147792 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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