Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CIV-23-10-044301 | Other Identifier | EUDAMED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Osypka AG | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Magnetic Interventional Ablation Catheter (MAGiC™) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAGiC™ | Device | Robotic magnetic radiofrequency (RF) ablation catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Performance | 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 | Freedom from major adverse events (MAE) related to MAGiC. | hospital discharge - up to 7 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Success | Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint. | 3 months, 6 months, 12 months |
| Safety Events | Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Betsy Lowry | Contact | 9737236613 | betsy.lowry@stereotaxis.com |
| Name | Affiliation | Role |
|---|---|---|
| Betsy Lowry | Stereotaxis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, University of Copenhagen | Recruiting | Copenhagen | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D017180 | Tachycardia, Ventricular |
| D013617 | Tachycardia, Supraventricular |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D008273 | Magic |
| ID | Term |
|---|---|
| D026443 | Spiritual Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months, 6 months, 12 months |
| Onset of Procedure-related New Arrhythmia | Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure. | 3 months, 6 months, 12 months |
| Vilniaus universiteto ligoninė Santaros klinikos | Recruiting | Vilnius | Lithuania |
|
| Erasmus Medical Center | Not yet recruiting | Rotterdam | 3015 GD | Netherlands |
|
| National Institute of Cardiology | Not yet recruiting | Warsaw | 04-628 | Poland |
|
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D005117 | Cardiac Complexes, Premature |