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This is a prospective, single-center study of patients with an indication for ventricular pacing who attempted LBBP without electrophysiology recording system (EP system).
Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, the implanter was blinded to EP system, only refer to ECG monitoring. The transition of QRS morphology from S-LBBP (or LVSP) to NS-LBBP, abrupt shortening of Stim-LVAT in lead V5, combined with LV septal-derived PVCs and obvious LBB potential in pacing system analyzer were recorded to help the implanter confirm LBB capture. Meanwhile, the technician recorded the data by EP system and evaluated the consistency of the judgment. The primary endpoints included the success rate, procedure-related information, parameters and complications during 3-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No EP system Group | Experimental | Patients were performed left bundle branch pacing without EP system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left bundle branch pacing | Device | Left bundle branch pacing by a CRT device or dual-chamber pacemaker through the pacing lead at left bundle branch region |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful rate | Success rate of left bundle branch pacing without EP system | Immediate Postoperative |
| Judgment coincidence rate | Coincidence rate between the judgment made by the operator through ECG and PSA with EP system. | Intraoperative |
| Intraoperative complications | Intraoperative complications were recorded | Immediate Postoperative |
| Postoperative complications | Postoperative complications were recorded | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | Total time required for operation | Immediate Postoperative |
| Fluoroscopy time | Intraoperative time of radiation use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weijian Huang, MD | Contact | +86 138-0669-1086 | weijianhuang69@126.com | |
| Lan Su, MD | Contact | +86 137-3874-2616 | 2512057600@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Weijian Huang, MD | Wenzhou 1st Affliated Hopsital, Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affliated Hospital, Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33426907 | Background | Su L, Wang S, Wu S, Xu L, Huang Z, Chen X, Zheng R, Jiang L, Ellenbogen KA, Whinnett ZI, Huang W. Long-Term Safety and Feasibility of Left Bundle Branch Pacing in a Large Single-Center Study. Circ Arrhythm Electrophysiol. 2021 Feb;14(2):e009261. doi: 10.1161/CIRCEP.120.009261. Epub 2021 Jan 9. | |
| 31136869 | Background |
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all IPD that underlie results in a publication
starting 6 months after publication
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| Immediate Postoperative |
| Change of threshold(V/0.5ms) from immediate postoperative | Threshold for capturing left bundle branch during unipolar pacing | 3 months |
| Change of LVEF(%) from baseline | LVEF changes before and after surgery | 3 months |
| Change of impedance(Ω) from immediate postoperative | Impedance during unipolar pacing | 3 months |
| Vijayaraman P, Subzposh FA, Naperkowski A, Panikkath R, John K, Mascarenhas V, Bauch TD, Huang W. Prospective evaluation of feasibility and electrophysiologic and echocardiographic characteristics of left bundle branch area pacing. Heart Rhythm. 2019 Dec;16(12):1774-1782. doi: 10.1016/j.hrthm.2019.05.011. Epub 2019 May 25. |
| 29173611 | Background | Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22. |