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New treatment option for Arrhythmias, Cardiac
Official title The MAGiC™ Cardiac Ablation European Study
ClinicalTrials.gov ID: NCT06019845
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging Unsafe device (implanted device or device that cannot be safely...
- 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...
- Presence of intracardiac thrombus within 12 weeks prior to enrollment
- Where MAGiC would need to cross a prosthetic valve
See the full eligibility 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.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Vilnius, Lithuania
- Rotterdam, Netherlands
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Vilnius, Lithuania; Rotterdam, Netherlands; Warsaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.