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Recruiting NCT06019845

The MAGiC™ Cardiac Ablation European Study

No phase Interventional Arrhythmias, Cardiac

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MAGiC™.
Who it may be relevant to
Registry conditions: Arrhythmias, Cardiac. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark, Lithuania, Netherlands, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The MAGiC™ Cardiac Ablation Feasibility Study / Pomt Market Clinical Follow-Up

Overview

The purpose of the first phase of this feasibility study is to gather safety and performance data on MAGiC to support European marketing approval. The purpose of MAGiC-FEST PMCF Study is to collect safety and performance data with MAGiC to meet ongoing regulatory obligations.

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. Now that MAGiC obtained European approval, the study has been amended and expanded to collect Post-Market Clinical Follow-up data.

Interventions

  • Device MAGiC™
    Robotic magnetic radiofrequency (RF) ablation catheter

Primary outcome measures

  • Acute Performance [Time frame: hospital discharge - up to 7 days post procedure]
  • Acute Safety [Time frame: hospital discharge - up to 7 days post procedure]
Secondary outcome measures (3)
  • Chronic Success [Time frame: 3 months, 6 months, 12 months]
  • Safety Events [Time frame: 3 months, 6 months, 12 months]
  • Onset of Procedure-related New Arrhythmia [Time frame: 3 months, 6 months, 12 months]

Eligibility criteria

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, lctrocardiographically documented within 12 months \[rior to enrollment;
  • Able to be safely exposed to magnetic fields;
  • Willing and capable to attend scheduled follow up visits at the study 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)
  • Women of childbearing age who are pregnant or who plan to become pregnant within the course of their participation in the study. Must have a negative pregnancy test.
  • Presence of intracardiac thrombus within 12 weeks prior to enrollment
  • 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
  • Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
  • Acute myocardial infarct (within the previous 6 weeks)
  • Recent cardiac surgery (within the previous 8 weeks)
  • Unstable angina at the time of enrollment
  • History of embolism (cerebrovascular accident, transient ischemic attack, systemic embolism) in the previous 30 days
  • Previous cardiac ablation within the previous 30 days
  • EP ablation within the previous 6 weeks.
  • Life expectancy <12 months per the physician opinion.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Rigshospitalet, University of Copenhagen — Copenhagen
Lithuania · 1 center
  • Vilniaus universiteto ligoninė Santaros klinikos — Vilnius
Netherlands · 1 center
  • Erasmus Medical Center — Rotterdam
Poland · 1 center
  • National Institute of Cardiology — Warsaw

Identifiers

NCT: NCT06019845 · MFEAS-001 · CIV-23-10-044301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗