MedTrace Logo

The CONFORMAL Early Feasibility Study

NCT03616028 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-02-13

No results posted yet for this study

Summary

An evaluation of the safety and performance of the Conformal Left Atrial Appendage Seal for Left Atrial Appendage Occlusion

Conditions

  • Non-valvular Atrial Fibrillation

Interventions

DEVICE

left atrial appendage closure

Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the CLAAS device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing

Sponsors & Collaborators

  • Yale Cardiovascular Research Group

    collaborator OTHER

  • Conformal Medical, Inc

    lead INDUSTRY

Principal Investigators

  • William A Gray, MD · Main Line Health Lankenau Institute for Medical Research

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2022-05-27
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03616028 on ClinicalTrials.gov