Arrhythmias, Cardiac
Conditions
Keywords
Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia, Supraventricular Tachycardia, Ablation, Premature Ventricular Contractions
Brief summary
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
DEVICEMAGiC™
Robotic magnetic radiofrequency (RF) ablation catheter
Sponsors
Stereotaxis
Osypka AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Performance | hospital discharge - up to 7 days post procedure | The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias. |
| Acute Safety | hospital discharge - up to 7 days post procedure | Freedom from major adverse events (MAE) related to MAGiC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic Success | 3 months, 6 months, 12 months | Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint. |
| Safety Events | 3 months, 6 months, 12 months | Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events. |
| Onset of Procedure-related New Arrhythmia | 3 months, 6 months, 12 months | Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure. |
Countries
Denmark, Lithuania, Netherlands, Poland
Contacts
CONTACTBetsy Lowry
STUDY_DIRECTORBetsy Lowry
Stereotaxis
Outcome results
None listed