Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status
- Conditions
- PacemakerAtrioventricular BlockClinical TrialsPacing
- Interventions
- Device: Micra AV implantation
- Registration Number
- NCT06587672
- Lead Sponsor
- Xiaohan Fan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 112
- 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)".
- Age ≥18 years.
- Expected lifespan ≥1 year.
- Consent to sign an informed consent form and cooperate in the collection of baseline data and subsequent follow-ups
- Patients anticipated to have a high ventricular pacing proportion (>40%) and with left ventricular ejection fraction less than 50%.
- Patients with persistent atrial fibrillation and a high expected ventricular pacing proportion.
- Post-tricuspid valve mechanical valve replacement surgery.
- Patients with inferior vena cava pathway anomalies, precluding passage of the leadless pacemaker's delivery sheath.
- Patients with an expected lifespan of less than 1 year. 6 Patients who are pregnant, planning pregnancy, or undergoing cardiac transplantation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients received Micra AV implantation Micra AV implantation Patients received Micra AV implantation
- Primary Outcome Measures
Name Time Method Complete the survey questionnair before implanting a pacemaker 1 day before implanting a pacemaker Complete the survey questionnair
The percentage of atrioventricular synchrony at 3 months after Micra AV implantation. 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.
- Secondary Outcome Measures
Name Time Method Immediate success rate of Micra AV implantation. During implantation on day 0 Successfully implant a Micra AV during procedure.
Ventricular pacing threshold, at 3 months, 6 months, and 1 year after Micra AV implantation. 3, 6, 12months post-implant Measuring the ventricular pacing threshold by a programmer at the outpatient clinic at 3,6 and 12 month.
Ventricular sensing at 3 months, 6 months, and 1 year after Micra AV implantation. 3, 6, 12 months post-implant Measuring ventricular sensing by a programmer at the outpatient clinic at 3,6 and 12 month.
Impedance at 3 months, 6months, and 1 year after Micra AV implantation. 3, 6, 12 months post-implant Measuring Impedance by a programmer at the outpatient clinic at 3,6 and 12 month.
Major complications related to the device implantation at perioperative period, and 3, 6, 9, 12 months after Micra AV implantation 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.
The percentage of atrioventricular synchrony at 6, 12 months after Micra AV implantation. 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.
Rehospitalization events related to heart failure at 3 months, 6 months, and 1year after Micra AV implantation. 3, 6, 12 months post-implant Rehospitalization events due to heart failure at 3 months, 6 months, and 1year after Micra AV implantation.
Tachycardia related to the pacemaker, or adverse events related to the device or algorithm at 3, 6, 12 months after Micra AV implantation. 3,6,12 months post-implant Tachycardia or or adverse events related to the device or algorithm during the follow-up
Left venriculat ejection fraction measured by echocardiography at 6, 12 months after Micra AV implanted 6, 12 months post-implant Left venriculat ejection fraction measured by echocardiography.
Left ventricular end-diastolic diameter measured by echocardiography at 6, 12 months after Micra AV implantation. 6, 12 months post-implant Left ventricular end-diastolic diameter measured by echocardiography
Parameter adjustment events related to the synchrony less than 70% at 3, 6, 12 months after Micra AV implantation.. 3, 6, 12months post-implant Parameter adjustment event will be defined as optimamizing the pacemaker parameters due to synchrony less than 70%.
Arrhythmias events at 3, 6, 12 months after Micra AV implantion 3, 6, 12months post-implant All kinds of arrhythmias events recorded via electrocardiogram or device during the follow up
Syncope events at 3, 6, 12 months after Micra AV implantion 3, 6, 12months post-implant Syncope events during the follow up
All-cause mortality rates at 3 months, 6 months, and 1 year after Micra AV implantation. 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.
Trial Locations
- Locations (1)
Fu Wai Hospital
🇨🇳Beijing, Beijing, China