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iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study

NCT05416086 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2026-04-13

No results posted yet for this study

Summary

A prospective, single-arm, multi-center study designed to collect real world safety and performance data of the Adagio Medical iCLAS Cryoablation System in the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibrillation (PsAF), and Atrial Flutter (AFL).

Conditions

  • Atrial Fibrillation
  • Atrial Flutter
  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation

Interventions

DEVICE

cryoablation procedure using the iCLAS Cryoablation System

all subjects will receive a cryoablation procedure using the iCLAS Cryoablation System (catheter, stylets, and console) and warming balloon

Sponsors & Collaborators

  • Adagio Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2025-01-28
Completion
2025-01-28

Countries

  • Belgium
  • Germany
  • Netherlands

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 NCT05416086 on ClinicalTrials.gov