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NCT05147792 · ClinicalTrials.gov record · last posted 2026-08-19

The CONFORM Pivotal Trial

StatusSuspended
PhaseNot applicable
Started2022-05-26
View on ClinicalTrials.gov ↗
Why the trial stopped
Enrollment has been temporarily suspended out of an abundance of caution and in close consultation with trial leadership and regulatory bodies to review overall study data thoroughly following a serious adverse event.
from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-08-20
Recruitment suspended
2026-08-20
Recruitment suspended: Enrollment has been temporarily suspended out of an abundance of caution and in close consultation with trial lead...
2026-06-17
Trial sites expanded: 88 → 91 locations
2026-05-07
Trial sites expanded: 83 → 88 locations
Trial Details
NCT Number NCT05147792
Lead Sponsor Conformal Medical, Inc
Conditions Atrial Fibrillation, Stroke
Enrollment 1,600 participants
Start Date 2022-05-26
Primary Completion 2028-06 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-19