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Cryoablation System FIM/CE Mark Study

NCT03723070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-04-04

Study results available
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Summary

Multi-center, open label, prospective clinical study to establish the acute safety and performance of the Cryterion Cardiac Cryoablation System

Conditions

Interventions

DEVICE

The Cryterion Cardiac Cryoablation System

Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins

Sponsors & Collaborators

  • Cryterion Medical, Inc.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Sarfaraz Taher · Boston Scientific Corporation

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
2018-05-15
Primary Completion
2020-12-22
Completion
2020-12-22

Countries

  • Croatia
  • Netherlands
  • New Zealand

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 NCT03723070 on ClinicalTrials.gov