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iCLAS™ for Persistent Atrial Fibrillation

NCT04061603 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2026-04-13

No results posted yet for this study

Summary

Clinical study to evaluate the safety and efficacy of the Adagio AF Cryoablation System (iCLAS™) in the ablation treatment of symptomatic, persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA)

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Adagio AF Cryoablation System (iCLAS™)

Endovascular ablation of the left and right atrium

Sponsors & Collaborators

  • Adagio Medical

    lead INDUSTRY

Principal Investigators

  • Suneet Mittal, MD · Valley Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-09
Primary Completion
2023-08-30
Completion
2024-08-30
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Netherlands

Study Locations

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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 NCT04061603 on ClinicalTrials.gov