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The goal of this observational study is to investigate the changes of LBB EGM during daily activities and overdrive pacing at the time of peri-implantation and up to 6-month follow-ups of ICD/CRT-D patients. The main question it aims to answer is:
• Does the LBBP lead can provide accurate, stable, and valid EGM for ICD/CRT-D sensing and detection of ventricular tachyarrhythmia events? In each patient intracardiac EGMs of LBBP lead will be collected by ambulatory Holter monitor at the time of peri-implantation and up to 6-month follow-up. EGM collection will be collected at resting and walking conditions and overdrive pacing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD or CRT-D patients who have received LBBP implantation | Patients' EGMs can be recorded by Holter DR220 |
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| Measure | Description | Time Frame |
|---|---|---|
| R-wave amplitude of LBB EGM | Amplitude in millivolt | At the enrollment, 3 months after enrollment and 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| EGM morphology-LVAT | LVAT in millisecond, calculated based on electrogram recorded by LBB lead | At the enrollment, 3 months after enrollment and 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| echocardiography results-LVEF | LVEF in percentage | At the enrollment and 6 months after enrollment |
| echocardiography results-SV | SV in millilitre |
Inclusion Criteria:
Exclusion Criteria:
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The study selected two study site in China. One is a Tertiary A hospital in Zhejiang Province, and another is a hospital in Shanghai. Both of the two sites locate in south east of China. This study will enroll around 50 subjects who meet the inclusion and exclusion criteria from the ICD or CRT-D patients who have received LBBAP in the two hospitals.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon Cao, Ph.D | Contact | 862133230325 | simon.cao@medtronic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36589004 | Result | Ponnusamy SS, Ramalingam V, Ganesan V, Syed T, Kumar M, Mariappan S, Murugan S, Basil W, Vijayaraman P. Left bundle branch pacing-optimized implantable cardioverter-defibrillator (LOT-ICD) for cardiac resynchronization therapy: A pilot study. Heart Rhythm O2. 2022 Dec 16;3(6Part B):723-727. doi: 10.1016/j.hroo.2022.08.004. eCollection 2022 Dec. |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| At the enrollment and 6 months after enrollment |
| echocardiography results-LVEDV | LVEDV in millilitre | At the enrollment and 6 months after enrollment |
| echocardiography results-LVESV | LVESV in millilitre | At the enrollment and 6 months after enrollment |
| echocardiography results-LVEDD | LVEDD in millimetre | At the enrollment and 6 months after enrollment |
| echocardiography results-LVESD | LVESD in millimetre | At the enrollment and 6 months after enrollment |
| Shanghai Tongren Hospital | Recruiting | Shanghai | 200025 | China |
|
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |