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| ID | Type | Description | Link |
|---|---|---|---|
| FF110 | Other Grant/Funding Number | BIOTRONIK SE & Co. KG |
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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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The goal of clinical trial is to prospectively collect data to investigate the prevalence of arrhythmia in young patients diagnosed with mitral annular disjunction who have no indication for implantable cardioverter defibrillator (ICD) or implantable loop recorder (ILR) implantation according to the current guideline. The study population is young (age 18-60), the participating patients have mitral annular disjunction confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium. This patient population has an increased risk of ventricular arrhythmias and sudden cardiac death. The investigators plan to implant 20 BioMonitor IIIm ILRs over a year in patients with mild or uncertain symptoms (dizziness, palpitations) and no malignant arrhythmias.
Aims of the study:
BioMonitor IIIm ILR implantation is planned in the following patient population:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAD-ILR | Experimental | Patients with mitral annular disjunction, confirmed by echocardiography and MR scan confirmed late-type gadolinium enhancement in the myocardium, undergoing loop recorder implantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| loop recorder implantation | Device | During the operation, a small incision is made in the chest with local anesthesia and the implantation is performed in a pacemaker operating room, following the rules of sepsis/antisepsis. The surgical suture is used to close the wound. The healing time is about 10 days, during which time a covering bandage is needed. During the operation we use absorbable sutures, no suture removal is necessary. After implantation, the patient's lifestyle is not restricted. Avoidance of strong magnetic fields, which may result in noise recording, is necessary. The procedure is performed as an outpatient surgery and patients are discharged to their homes on the day of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventricular arrhythmia screened with loop recorder | Periprocedurally, at 6-, 12-, 18- and 24-month follow-up, we perform control examinations (e.g. 12-lead ECG, echocardiography, ILR interrogation). Arrhythmias recorded by ILR are documented and analyzed. Our results may contribute to a better understanding of the indications for ILR and ICD implantation in patients with MAD, thereby helping to reduce the risk of sudden cardiac death. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Attila Kardos, MD PhD | Contact | +36703388864 | attila.kardos@gokvi.hu | |
| Sara Mladoniczky, MD | Contact | +36301550424 | sara.mladoniczky@gokvi.hu |
| Name | Affiliation | Role |
|---|---|---|
| Attila Kardos, MD PhD | Gottsegen National Cardiovascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gottsegen National Cardiovascular Institute | Recruiting | Budapest | 1096 | Hungary |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |