An observational study in Pacemaker, Atrioventricular Block and Clinical Trials, sponsored by Xiaohan Fan. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Xiaohan Fan · Observational
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.
117 studies on the registry are indexed under Atrioventricular Block; 43 are open to participants now.
This study's planned enrollment of 112 is below the median of 300 across 37 observational studies indexed under Atrioventricular Block.
Browse Atrioventricular Block studies →This is the only study on the registry with Xiaohan Fan as lead sponsor.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients received Micra AV implantation
Device: Micra AV implantation
Patients received Micra AV implantation
Complete the survey questionnair before implanting a pacemaker
Complete the survey questionnair
Time frame: 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.
Time frame: 3 months post-implant
Immediate success rate of Micra AV implantation.
Successfully implant a Micra AV during procedure.
Time frame: During implantation on day 0
The percentage of atrioventricular synchrony at 6, 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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%.
Time frame: 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
Time frame: 3, 6, 12months post-implant
Syncope events at 3, 6, 12 months after Micra AV implantion
Syncope events during the follow up
Time frame: 3, 6, 12months post-implant
Plan to share: No
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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