The MAGiC™ Cardiac Ablation European Study (MAGiC-FEST)

March 22, 2024 updated by: Stereotaxis

The MAGiC™ Cardiac Ablation Feasibility Study

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. After MAGiC obtains European approval, the study will be amended and expanded to collect Post-Market Clinical Follow-up data.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (aged 18 or older at time of consent);
  • Eligible for ablation procedures of an atrial or ventricular arrhythmia per European Heart Rhythm Association (EHRA) guidelines, with at least one (1) documented episode of the tachyarrhythmia to be treated within the previous six (6) months;
  • Able to be safely exposed to magnetic fields;
  • Willing and capable to attend scheduled follow up visits at the investigational site for the study duration (up to 12 months)
  • Willing and able to provide informed consent.

Exclusion Criteria:

  • Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging Unsafe device (implanted device or device that cannot be safely removed for the procedure)
  • Unable to remain comfortable or hemodynamically stable in the supine position for an extended period of time
  • Weight exceeding 200 kg (the weight limit of the table)
  • For female patients of childbearing potential: pregnancy at the time of the procedure or unwilling to take a pregnancy test
  • Presence of intracardiac thrombus at the time of the procedure
  • Where MAGiC would need to cross a prosthetic valve
  • Use of MAGiC in the coronary arteries
  • A history of sensitivity to foreign objects or extreme allergies
  • Acute illness or active systemic infection
  • Histological or anatomical abnormalities that may lead to post-operative complications including diminished resistance to infection
  • Hemodynamic instability
  • Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
  • Acute myocardial infarct (within the previous 30 days)
  • Recent cardiac surgery (within the previous 60 days)
  • Unstable angina
  • History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days
  • Previous cardiac ablation within the previous 30 days
  • Concomitant arrhythmia(s) requiring active treatment at this time or in the 90 days prior to enrollment (Day -90 to Day 0)
  • Currently or in the 30 days prior to consent, participation in an interventional clinical trial
  • Significant uncontrolled or unstable medical problems which, in the opinion of the Investigator, would preclude enrollment in and completion of the study (limitation on survival).
  • Any reason or condition that, in the judgement of the investigator, makes the patient ineligible for the investigation.
  • For Atrial Fibrillation only: persistent Atrial Fibrillation (continuous Atrial Fibrillation lasting longer than 7 days)
  • For Atrial Fibrillation only: Presence of any device that would interfere with planned access: Patent Foramen Ovale occlusion/closure device, patch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Magnetic Interventional Ablation Catheter (MAGiC™)
Device: MAGiC™
Robotic magnetic radiofrequency (RF) ablation catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Performance
Time Frame: hospital discharge - up to 7 days post procedure
The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.
hospital discharge - up to 7 days post procedure
Acute Safety
Time Frame: hospital discharge - up to 7 days post procedure
Freedom from major adverse events (MAE) related to MAGiC.
hospital discharge - up to 7 days post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Success
Time Frame: 3 months, 6 months, 12 months
Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.
3 months, 6 months, 12 months
Safety Events
Time Frame: 3 months, 6 months, 12 months
Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.
3 months, 6 months, 12 months
Onset of Procedure-related New Arrhythmia
Time Frame: 3 months, 6 months, 12 months
Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.
3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stereotaxis

Collaborators

Osypka AG

Investigators

  • Study Director: Betsy Lowry, Stereotaxis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFEAS-001
  • CIV-23-10-044301 (Other Identifier: EUDAMED)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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