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Observational study is to demonstrate a clinically significant reduction of ionizing radiation exposure during transcatheter ablation of supraventricular tachycardias using the EnSite precision mapping system in a real-world clinical setting without compromising efficacy and safety.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrophysiology Study and Ablation | Procedure | Electrophysiology Study and Ablation of Supraventricular Arrhythmias |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation exposure dose | The dose of ionizing radiation exposure in patients undergoing Supraventricular Tachycardia catheter ablation utilizing a non-fluoroscopic EnSite Precision 3D mapping system | The day of performing the procedure |
| Incidence of procedure related cardiac Adverse Events (Safety) | Cardiac related serious adverse events frequency during and after ablation procedure of supraventricular arrhythmias | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy time | Fluoroscopy time during the procedure | The day of performing the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients ≥ 18 years of age, indicated for supraventricular arrhythmias ablation according to the current local applicable guidelines
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MOHAMMAD AMIN | Contact | 0097317767739 | drmohdamin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohammad Amin, MRCP(UK)FHRS | Mohamed Bin Khalifa Cardiac Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohamed Bin Khalifa Cardiac Center | Recruiting | Riffa | Bahrain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39331462 | Derived | Amin M, Abdrakhmanov A, Kropotkin E, Traykov V, Sallo Z, Geller L, Lorgat F, Sapelnikov O, Toman O, Al-Muti K, Aljaabari M, Bystriansky A, Kornyei L, Mujovic N, Simons S, Szegedi N. Ablation of Supraventricular Arrhythmias With as Low as Reasonably Achievable X-Ray exposure (AALARA): Results of Prospective, Observational, Multicenter, Multinational, Open-Label Registry Study on Real World Data Using Routine Ensite 3D Mapping During SVT Ablation. Pacing Clin Electrophysiol. 2024 Nov;47(11):1441-1448. doi: 10.1111/pace.15075. Epub 2024 Sep 27. | |
| 37541748 |
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| ID | Term |
|---|---|
| D013617 | Tachycardia, Supraventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Derived |
| Szegedi N, Kroptkin E, Traykoc V, Abdrakhmanov A, Lorgat F, Sapelnikov O, Simons S, Amin M. Routine use of a 3D mapping system in the ablation of supraventricular arrhythmias with as low as reasonably achievable X-ray exposure (AALARA): protocol for a prospective, observational, multicentre, multinational, open-label registry study. BMJ Open. 2023 Aug 4;13(8):e072181. doi: 10.1136/bmjopen-2023-072181. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |