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| Name | Class |
|---|---|
| Tianjin Chest Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Peking University First Hospital |
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This is a multicenter, prospective, observational study ,the aim of this study is to find factors affecting selection of double-chamber leadless pacemaker in patients with atrioventricular block and ambulatory atrioventricular synchronous pacing status over time using a leadless ventricular pacemaker.
Traditional pacemakers consist of a pulse generator and leads. Infections of the pulse generator pocket and lead-related complications are unavoidable issues in the application oftraditional pacemakers.Leadless pacemakers have emerged to address complications associated with the pacemaker pocket and leads in specific patients.The initial design of leadless pacemakers focused on single-chamber (right ventricular)sensing and pacing,However, patients with sinus rhythm may experience pacemakersyndrome symptoms due to atrioventricular desynchrony. Furthermore, a high proportion of atrioventricular dyssynchronous ventricular pacing might increase hospitalization rates for atrial fibrillation and heart failure.Recent developments in leadless dual-chamber pacemakersutilize a built-in triaxial accelerometer.This study aims to investigate factors considered by patients with atrioventricular block and clinical pacemaker implanting physicians when make sure the use of Micra AV. 2). It also seeks to evaluate the atrioventricular synchrony of Micra AV pacing in patients during both exercise and rest, while analyzing factors that influence the AV synchrony.For all screened patients, a questionnaire is required to be finished with data including age, gender, occupation, educational level, clinical history, comorbidities, previous infections, history of implanted electronic devices, economic status, and medical insurance conditions. At same time, all physicians are asked to complete a questionnaire for analyzing the factors influencing the decision of device option.An ambulatory electrocardiogram will be performed at 3 months, 6 months, and 1 year follow-up after device implantation. Data regarding the proportion of atrioventricular Research Protocol Template (Observational Study)_V1.0_2023.10.04 7/10 synchrony, atrial sensing atrial contraction mechanical wave (A4) threshold, ventricular pacing threshold, sensing, and impedance will be tested and collected. Postoperative exercise related symptoms and adverse events will be routinely tracked.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients received Micra AV implantation | Patients received Micra AV implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micra AV implantation | Device | Patients received Micra AV implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete the survey questionnair before implanting a pacemaker | Complete the survey questionnair | 1 day before implanting a pacemaker |
| The percentage of atrioventricular synchrony at 3 months after Micra AV implantation. | The percentage of atrioventricular synchrony will be calculated based on the recording of a 20-minute resting period in the outpatient consulting room, via dividing the total number of AV synchronous cycles by the total number of cardiac cycles recoded by a Holter. An AV synchronous cycle will be defined as a paced or sensed ventricular beat within 300 ms following a surface ECG confirmed P-wave. | 3 months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate success rate of Micra AV implantation. | Successfully implant a Micra AV during procedure. | During implantation on day 0 |
| The percentage of atrioventricular synchrony at 6, 12 months after Micra AV implantation. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with atrioventricular conduction block, meeting the indications for dual-chamber leadless pacemakers as per the "Chinese Expert Consensus on Clinical Application of Leadless Pacemakers (2022)".All patients should sign written informed consent for agreement of the implantation procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohan Fan | Contact | +861088322393 | +861088322393 | fanxiaohan@fuwaihospital.org |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohan Fan, MD,PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Wai Hospital | Beijing | Beijing Municipality | 100037 | China | ||
| Peking University First Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17954409 | Background | Wilkoff BL. How to treat and identify device infections. Heart Rhythm. 2007 Nov;4(11):1467-70. doi: 10.1016/j.hrthm.2007.08.007. Epub 2007 Aug 11. No abstract available. | |
| 21252172 | Background | Johansen JB, Jorgensen OD, Moller M, Arnsbo P, Mortensen PT, Nielsen JC. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J. 2011 Apr;32(8):991-8. doi: 10.1093/eurheartj/ehq497. Epub 2011 Jan 20. |
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| ID | Term |
|---|---|
| D054537 | Atrioventricular Block |
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| OTHER |
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The percentage of atrioventricular synchrony will be calculated based on the recording of a 20-minute resting period in the outpatient consulting room, via dividing the total number of AV synchronous cycles by the total number of cardiac cycles recoded by a Holter. An AV synchronous cycle will be defined as a paced or sensed ventricular beat within 300 ms following a surface ECG confirmed P-wave.
| 6, 12 months post-implant |
| Ventricular pacing threshold, at 3 months, 6 months, and 1 year after Micra AV implantation. | Measuring the ventricular pacing threshold by a programmer at the outpatient clinic at 3,6 and 12 month. | 3, 6, 12months post-implant |
| Ventricular sensing at 3 months, 6 months, and 1 year after Micra AV implantation. | Measuring ventricular sensing by a programmer at the outpatient clinic at 3,6 and 12 month. | 3, 6, 12 months post-implant |
| Impedance at 3 months, 6months, and 1 year after Micra AV implantation. | Measuring Impedance by a programmer at the outpatient clinic at 3,6 and 12 month. | 3, 6, 12 months post-implant |
| Major complications related to the device implantation at perioperative period, and 3, 6, 9, 12 months after Micra AV implantation | Major complations related to the device implantation include, pericardial effusion, dislodgement, threshold elevation or loss of capture, infection, etc. | Days 0,1 and 3, 6, 9, 12 months post- implant |
| All-cause mortality rates at 3 months, 6 months, and 1 year after Micra AV implantation. | These data will be collected at the outpatient clinic at 3,6 and 12 month, 9-month follow-up will be conducted via telephone. | 3, 6, 9, 12 months post-implant |
| Rehospitalization events related to heart failure at 3 months, 6 months, and 1year after Micra AV implantation. | Rehospitalization events due to heart failure at 3 months, 6 months, and 1year after Micra AV implantation. | 3, 6, 12 months post-implant |
| Tachycardia related to the pacemaker, or adverse events related to the device or algorithm at 3, 6, 12 months after Micra AV implantation. | Tachycardia or or adverse events related to the device or algorithm during the follow-up | 3,6,12 months post-implant |
| Left venriculat ejection fraction measured by echocardiography at 6, 12 months after Micra AV implanted | Left venriculat ejection fraction measured by echocardiography. | 6, 12 months post-implant |
| Left ventricular end-diastolic diameter measured by echocardiography at 6, 12 months after Micra AV implantation. | Left ventricular end-diastolic diameter measured by echocardiography | 6, 12 months post-implant |
| Parameter adjustment events related to the synchrony less than 70% at 3, 6, 12 months after Micra AV implantation.. | Parameter adjustment event will be defined as optimamizing the pacemaker parameters due to synchrony less than 70%. | 3, 6, 12months post-implant |
| Arrhythmias events at 3, 6, 12 months after Micra AV implantion | All kinds of arrhythmias events recorded via electrocardiogram or device during the follow up | 3, 6, 12months post-implant |
| Syncope events at 3, 6, 12 months after Micra AV implantion | Syncope events during the follow up | 3, 6, 12months post-implant |
| Beijing |
| Beijing Municipality |
| 100037 |
| China |
| 25881930 | Background | Knops RE, Tjong FV, Neuzil P, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Reddy VY. Chronic performance of a leadless cardiac pacemaker: 1-year follow-up of the LEADLESS trial. J Am Coll Cardiol. 2015 Apr 21;65(15):1497-504. doi: 10.1016/j.jacc.2015.02.022. |
| 24664277 | Background | Reddy VY, Knops RE, Sperzel J, Miller MA, Petru J, Simon J, Sediva L, de Groot JR, Tjong FV, Jacobson P, Ostrosff A, Dukkipati SR, Koruth JS, Wilde AA, Kautzner J, Neuzil P. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation. 2014 Apr 8;129(14):1466-71. doi: 10.1161/CIRCULATIONAHA.113.006987. Epub 2014 Mar 24. |
| 27355552 | Background | Reynolds DW, Ritter P. A Leadless Intracardiac Transcatheter Pacing System. N Engl J Med. 2016 Jun 30;374(26):2604-5. doi: 10.1056/NEJMc1604852. No abstract available. |
| 25980618 | Result | Ann HW, Ahn JY, Jeon YD, Jung IY, Jeong SJ, Joung B, Lee M, Ku NS, Han SH, Kim JM, Choi JY. Incidence of and risk factors for infectious complications in patients with cardiac device implantation. Int J Infect Dis. 2015 Jul;36:9-14. doi: 10.1016/j.ijid.2015.05.011. Epub 2015 May 14. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |