Clinical trial NCT06587672: Factors Affecting Selection of Leadless Pacemaker and Atrioventricular Synchronous Pacing Status
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pacemaker
Atrioventricular Block
Clinical Trials
Pacing
Keywords: Leadless pacing
Atrioventricular synchrony
Atrioventricular block
Atrial contraction
Lead sponsor: Fu Wai Hospital, Beijing, China
Sponsor class: OTHER
Collaborators: name: Tianjin Chest Hospital
name: Beijing Friendship Hospital
name: Beijing Hospital
name: Peking University First Hospital
First posted: 2024-09-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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)".
2. Age ≥18 years.
3. Expected lifespan ≥1 year.
4. Consent to sign an informed consent form and cooperate in the collection of baseline data and subsequent follow-ups

Exclusion Criteria:

1. Patients anticipated to have a high ventricular pacing proportion (\>40%) and with left ventricular ejection fraction less than 50%.
2. Patients with persistent atrial fibrillation and a high expected ventricular pacing proportion.
3. Post-tricuspid valve mechanical valve replacement surgery.
4. Patients with inferior vena cava pathway anomalies, precluding passage of the leadless pacemaker's delivery sheath.
5. Patients with an expected lifespan of less than 1 year. 6 Patients who are pregnant, planning pregnancy, or undergoing cardiac transplantation.

Primary outcomes:
measure: Complete the survey questionnair before implanting a pacemaker
timeFrame: 1 day before implanting a pacemaker
measure: The percentage of atrioventricular synchrony at 3 months after Micra AV implantation.
timeFrame: 3 months post-implant
Secondary outcomes:
measure: Immediate success rate of Micra AV implantation.
timeFrame: During implantation on day 0
measure: The percentage of atrioventricular synchrony at 6, 12 months after Micra AV implantation.
timeFrame: 6, 12 months post-implant
measure: Ventricular pacing threshold, at 3 months, 6 months, and 1 year after Micra AV implantation.
timeFrame: 3, 6, 12months post-implant
measure: Ventricular sensing at 3 months, 6 months, and 1 year after Micra AV implantation.
timeFrame: 3, 6, 12 months post-implant
measure: Impedance at 3 months, 6months, and 1 year after Micra AV implantation.
timeFrame: 3, 6, 12 months post-implant
measure: Major complications related to the device implantation at perioperative period, and 3, 6, 9, 12 months after Micra AV implantation
timeFrame: Days 0,1 and 3, 6, 9, 12 months post- implant
measure: All-cause mortality rates at 3 months, 6 months, and 1 year after Micra AV implantation.
timeFrame: 3, 6, 9, 12 months post-implant
measure: Rehospitalization events related to heart failure at 3 months, 6 months, and 1year after Micra AV implantation.
timeFrame: 3, 6, 12 months post-implant
measure: Tachycardia related to the pacemaker, or adverse events related to the device or algorithm at 3, 6, 12 months after Micra AV implantation.
timeFrame: 3,6,12 months post-implant
measure: Left venriculat ejection fraction measured by echocardiography at 6, 12 months after Micra AV implanted
timeFrame: 6, 12 months post-implant
measure: Left ventricular end-diastolic diameter measured by echocardiography at 6, 12 months after Micra AV implantation.
timeFrame: 6, 12 months post-implant
measure: Parameter adjustment events related to the synchrony less than 70% at 3, 6, 12 months after Micra AV implantation..
timeFrame: 3, 6, 12months post-implant
measure: Arrhythmias events at 3, 6, 12 months after Micra AV implantion
timeFrame: 3, 6, 12months post-implant
measure: Syncope events at 3, 6, 12 months after Micra AV implantion
timeFrame: 3, 6, 12months post-implant
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Wai Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xiaohan Fan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.