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The CONFORM Pivotal Trial

NCT05147792 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2026-05-06

No results posted yet for this 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

Interventions

DEVICE

CLAAS

CLAAS

DEVICE

WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder

Sponsors & Collaborators

  • Conformal Medical, Inc

    lead INDUSTRY

Principal Investigators

  • William Gray, M.D. · Lankenau Heart Institute

  • Shephal Doshi, M.D. · Pacific Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
Primary Completion
2028-06-30
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States
  • Czechia
  • France
  • Georgia
  • Uzbekistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05147792 on ClinicalTrials.gov