Micra AV implantation
DevicePatients received Micra AV implantation
NCT Number: NCT06587672
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Fu Wai Hospital, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received Micra AV implantation
Time frame: 1 day before implanting a pacemaker
Complete the survey questionnair
Time frame: 3 months post-implant
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: During implantation on day 0
Successfully implant a Micra AV during procedure.
Time frame: 6, 12 months post-implant
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, 6, 12months post-implant
Measuring the ventricular pacing threshold by a programmer at the outpatient clinic at 3,6 and 12 month.
Time frame: 3, 6, 12 months post-implant
Measuring ventricular sensing by a programmer at the outpatient clinic at 3,6 and 12 month.
Time frame: 3, 6, 12 months post-implant
Measuring Impedance by a programmer at the outpatient clinic at 3,6 and 12 month.
Time frame: Days 0,1 and 3, 6, 9, 12 months post- implant
Major complations related to the device implantation include, pericardial effusion, dislodgement, threshold elevation or loss of capture, infection, etc.
Time frame: 3, 6, 9, 12 months post-implant
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, 12 months post-implant
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 or or adverse events related to the device or algorithm during the follow-up
Time frame: 6, 12 months post-implant
Left venriculat ejection fraction measured by echocardiography.
Time frame: 6, 12 months post-implant
Left ventricular end-diastolic diameter measured by echocardiography
Time frame: 3, 6, 12months post-implant
Parameter adjustment event will be defined as optimamizing the pacemaker parameters due to synchrony less than 70%.
Time frame: 3, 6, 12months post-implant
All kinds of arrhythmias events recorded via electrocardiogram or device during the follow up
Time frame: 3, 6, 12months post-implant
Syncope events during the follow up
Contact information is provided by the study sponsor or research team.
Xiaohan Fan
Other
Factors Affecting Selection of Leadless Pacemaker in Patients With Atrioventricular Block and Atrioventricular Synchronous Pacing Status With a Micra AV: a Multicenter, Prospective, Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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