MedTrace Logo

Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation

NCT04523545 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-08-22

No results posted yet for this study

Summary

This study is a prospective, single-arm, open-label study following patients to 1 year, to evaluate the safety and performance of the Centauri System for catheter ablation of atrial fibrillation (AF). The study is intended for adult patients (age 18-75 years) who are indicated for a first-time catheter ablation of AF where the pre-procedure treatment plan contemplates pulmonary vein isolation (PVI) in patients with paroxysmal AF (PAF) or short-duration (\<1 year) persistent AF (PeAF).

Conditions

Interventions

DEVICE

cardiac ablation

cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation

Sponsors & Collaborators

  • Galaxy Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2023-04-30
Completion
2023-04-30
FDA Device
Yes

Countries

  • Croatia

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 NCT04523545 on ClinicalTrials.gov