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NCT05147792 · ClinicalTrials.gov registry record · NA
The CONFORM Pivotal Trial
A NA study of Stroke and Atrial Fibrillation, sponsored by Conformal Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 1,600
- Enrollment target
- 20
- Study locations
NCT05147792 is a NA study of Stroke and Atrial Fibrillation that is actively recruiting participants, run by Conformal Medical. The registered enrollment target is 1,600 participants, below the 12,013-participant average among 454 other Stroke trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 7 states.
The verdict
NCT05147792, a NA study of Stroke and Atrial Fibrillation, is actively recruiting participants, sponsored by Conformal Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,600 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. The registered enrollment target is 1,600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,013-participant average among 454 other Stroke trials with a reported enrollment target (87% lower). The listed sponsor is Conformal Medical, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT05147792 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Florida, Arizona, California.
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.
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).
Who is sponsoring clinical trial NCT05147792?
This trial is sponsored by Conformal Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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