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| Name | Class |
|---|---|
| Biotronik SE & Co. KG | INDUSTRY |
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This prospective multi-center randomized controlled study aims to compare atrial fibrillation detection and inappropriate therapy according to activation of atrial sensing capability in patients with implantable cardioverter defibrillator.
Implantable cardioverter defibrillators(ICD) therapy has been shown to reduce sudden cardiac death and improve survival in cardiac arrest survivors as well as in heart failure patients with left ventricular dysfunction.
Atrial fibrillation (AF) is commonly found in ICD implantation patients up to 50%. AF is an independent predictor of mortality, inappropriate shock, and embolic events. Therefore, early detection of AF in patients with ICD is essential for improving the quality of life and overall prognosis of the patients.
Conventional ICDs consist of a single chamber (SC) ICD with a lead only in the right ventricle (RV) and dual chamber (DC) ICD with each lead in the right atrium (RA) and RV. SC ICD has the advantage of shorter procedure time, lower cost compared to DC ICD. In contrast, DC ICD has the advantage of being able to monitor atrial arrhythmic events, but complication rates were higher and additional cost and longer procedure time are usually required than SC ICD. Sixty percent of ICD implantation patients who have are SC ICD Recently, a unique ICD lead with atrial sensing ring capable of monitoring the atrial electrical signals has been developed [Intica 7 VR-T DX ICD (Biotronik., Germany)]. Therefore, turning off the atrial sensing function makes it functionally the same as SC ICD whereas turning on makes it function similar to DC ICD without additional cost and procedure time.
Therefore, Detection of AF could be made earlier with VDD ICD versus conventional SC ICD without atrial sensing capability, providing a better chance to improve the prognosis of ICD patients. However, no study exists which shows whether VDD ICD is better for detecting atrial tachyarrhythmia than conventional SC ICD. Therefore, we designed a multicenter prospective randomized study comparing the AF diagnostic efficacy of VDD ICD (with atrial sensing 'ON') against conventional SC ICD. As the second phase, we also plan to compare inappropriate therapy rate according to atrial sensing status of VDD ICD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial sensing OFF mode | No Intervention | VDD-ICD programmed as atrial sensing Off mode | |
| Atrial sensing ON mode | Active Comparator | VDD-ICD programmed as atrial sensing ON mode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial sensing On mode | Device | Single lead VDD-ICD programmed as atrial sensing On mode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation | cardiac implantable electronic device-detected or clinical atrial fibrillation | from enrollment to last follow-up (2 years) |
| Inappropriate device therapy | inappropriate ATP or shock | from enrollment to last follow-up (2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with complications associated with atrial fibrillation | thromboembolic events, heart failure | from enrollment to last follow-up (2 years) |
| Number of Participants with ventricular arrhythmia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seung-Jung Park, PhD | Contact | +82-2-3410-7145 | orthovics@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seung-Jung Park, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sejong General Hospital | Recruiting | Bucheon-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35568193 | Derived | Gwag HB, Kim HR, Park SJ, Kim J, Chung TW, Choi JH, Kim JY, Park KM, On YK, Kim JS. The efficacy of single-lead implantable cardioverter-defibrillator with atrial sensing dipole to detect atrial fibrillation and to reduce inappropriate therapy according to atrial sensing ON or OFF: Rationale and design of the SMART-CONTROL study, a prospective multicenter randomized trial. Am Heart J. 2022 Sep;251:25-31. doi: 10.1016/j.ahj.2022.05.008. Epub 2022 May 12. |
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Patients are randomly assigned as atrial sensing ON or Off mode
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cardiac implantable electronic device-detected or clinical ventricular arrhythmia
| from enrollment to last follow-up (2 years) |
| Number of Participants with major adverse composite events | cardiac death, all cuase death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure | from enrollment to last follow-up (2 years) |
| atrial lead sensing stability | Atrioventricular synchrony ratio | from enrollment to last follow-up (2 years) |
| Inje University Busan Paik Hospital | Recruiting | Busan | South Korea |
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| Samsung Changwon Medical Center | Recruiting | Changwon | South Korea |
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| Chungbuk National University Hospital | Recruiting | Cheongju-si | South Korea |
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| Kangwon National University Hospital | Recruiting | Chuncheon | South Korea |
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| Daegu Catholic University Medical Center | Recruiting | Daegu | South Korea |
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| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
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| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
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| Yeongnam University Medical Center | Recruiting | Daegu | South Korea |
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| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
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| GangNeung Asan Hospital | Recruiting | Gangneung | South Korea |
|
| National Health Insurance Service Ilsan Hospital | Recruiting | Goyang | South Korea |
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| Gachon University, Donginchoen Gil Hospital | Recruiting | Incheon | South Korea |
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| Inha University Hospital | Recruiting | Incheon | South Korea |
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| Mediplex Sejong Hospital | Recruiting | Incheon | South Korea |
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| Kosin University Gospel Hospital | Recruiting | Pusan | South Korea |
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| Pusan National University Hospital | Recruiting | Pusan | South Korea |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
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| Hallym University Medical Center-Kangnam | Recruiting | Seoul | South Korea |
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| Kangbuk Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Koera University Guro Hospital | Recruiting | Seoul | South Korea |
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| Kyung Hee University Hospital | Recruiting | Seoul | South Korea |
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| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Recruiting | Seoul | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| VHS Medical Center | Recruiting | Seoul | South Korea |
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| Ajou University Hospital | Recruiting | Suwon | South Korea |
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| The Catholic University of Korea, St. Vincent's Hospital | Recruiting | Suwon | South Korea |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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