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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: Recruiting NA study of Stroke and Atrial Fibrillation, sponsored by Conformal Medical.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

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

FieldValue
Enrollment Target 1,600 participants
Start Date 2022-05-26
Est. Completion 2031-12
Phase NA
Conformal Medical

2 total trials

What NCT05147792 shows while recruiting

NCT05147792 is an interventional study that assigns participants to a tested intervention. Its 1,600 participants enrollment target places it among the larger protocols in the corpus, below the 12,013-participant average among 454 other Stroke trials with a reported enrollment target (87% lower).

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 names 20 study sites across 7 states, led by 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.

Similar trials for Stroke

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05147792's enrollment target sits among peer trials

1,600 30th of 454 higher than 425 of 454 other Stroke trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05147792, the US trial registry maintained by the National Library of Medicine. NCT05147792 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.