Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Rate of Participants with Sustained Successful Aveir VR Lead Implantation (evaluated by fluoroscopy and clinical-electrophysiological follow-up)
研究概览
简要总结
This study is a prospective, single-arm, single-center feasibility study evaluating the safety and feasibility of transjugular (internal jugular vein) implantation of the Aveir VR leadless ventricular pacemaker in patients requiring ventricular pacing. A total of 15 patients will be enrolled at Xijing Hospital. The primary objective is to assess procedural feasibility and acute safety (from intraoperative to 48 hours post-procedure). Secondary objectives include short-term (1 to 3 months) pacing parameter stability (threshold, R-wave amplitude, impedance), technical success rate, procedure-related metrics, and adverse event rates.
详细描述
Background: Leadless pacemakers have emerged as an important alternative to conventional transvenous pacing systems, offering advantages such as reduced pocket-related complications and improved patient tolerance. The Aveir VR (Abbott) is an active-fixation leadless ventricular pacemaker with a retractable helix and retrievable design. While the femoral approach is standard, some patients have contraindications to femoral access (e.g., venous occlusion, severe obesity). The internal jugular vein approach offers a potential alternative, but clinical data-particularly from China-remain limited.
Objectives: To evaluate the feasibility and acute (intraoperative to 48h) safety of transjugular implantation of Aveir VR, and to assess short-term (1-3 months) pacing parameter stability and safety in a Chinese population.
Study Design: Prospective, single-arm, single-center feasibility study. Fifteen patients aged 18-85 years with symptomatic bradycardia requiring ventricular pacing will be enrolled. The procedure will be performed via the right internal jugular vein (or external jugular if needed) under local anesthesia. Pacing parameters (threshold, R-wave amplitude, impedance) will be tested intraoperatively and at 1-month and 3-month follow-up. Implant location (right ventricular septal vs. free wall) will be assessed by echocardiography or cardiac CT before discharge. Safety will be evaluated through adverse event monitoring from consent through 3 months post-procedure. Descriptive statistics will be used; no formal hypothesis testing will be performed given the exploratory feasibility nature of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 85 years, regardless of gender.
- •Symptomatic bradyarrhythmia meeting the ventricular pacing indications recommended by the 2023 ACC/AHA/HRS Guideline for the Evaluation and Management of Bradyarrhythmias, the 2020 Chinese Expert Consensus on the Evaluation and Management of Patients with Bradycardia and Conduction Disorders, and the 2022 Chinese Expert Consensus on the Clinical Application of Leadless Pacemakers, including any of the following conditions:
- •Third-degree or advanced atrioventricular (AV) block;
- •Second-degree type II AV block, alternating bundle branch block, or bifascicular/trifascicular block with intermittent advanced/third-degree AV block;
- •Adult congenital complete AV block; persistent irreversible advanced/third-degree AV block following myocardial infarction or cardiac surgery;
- •Symptomatic bradycardia (e.g., dizziness, presyncope, syncope, fatigue, decreased exercise tolerance) or sick sinus syndrome (including chronotropic incompetence and tachy-brady syndrome);
- •Drug-induced persistent symptomatic bradycardia with no alternative treatment options;
- •Atrial fibrillation with slow ventricular response requiring long-term ventricular pacing;
- •New-onset persistent complete left bundle branch block after TAVR, or new-onset advanced AV block after hypertrophic cardiomyopathy ablation;
- •Neuromuscular disease, infiltrative cardiomyopathy, or adult congenital heart disease with progressive AV/branch conduction abnormalities and bradycardia-related symptoms;
- •High infection risk populations (e.g., recurrent pacing system infection, diabetes mellitus, long-term corticosteroid use, end-stage renal disease on dialysis) or patients with abnormal conventional pacing access or at extremely high risk of conventional pacing lead complications.
- •Anatomical feasibility and vascular access assessment:
- •Preoperative imaging confirms suitable right internal jugular vein access to accommodate the delivery sheath, without thrombosis, severe stenosis, or anatomical malformations;
- •Right ventricular anatomy is suitable with adequate trabeculation to support active fixation of the leadless pacemaker, without severe structural abnormalities;
- •Priority for enrollment: patients with limited femoral or inferior vena cava access (e.g., iliac/inferior vena cava stenosis, thrombosis, prior venous surgery, obesity precluding femoral access).
- •New York Heart Association (NYHA) functional class ≤ III, and expected survival > 1 year.
- •Able to cooperate with preoperative evaluation, intraoperative procedure, and 3-month follow-up.
- •Voluntarily signs written informed consent and agrees to complete all scheduled observations per the study protocol.
排除标准
- •Anatomical malformations, severe stenosis, occlusion, or thrombosis of the internal jugular vein or superior vena cava that preclude transjugular access for the procedure.
- •Abnormal right ventricular anatomy, including but not limited to right ventricular hypoplasia, severe right ventricular dilation, or severe right ventricular myocardial fibrosis, preventing safe implantation of an active-fixation leadless ventricular pacemaker.
- •Severe tricuspid regurgitation, or status post-mechanical tricuspid valve replacement, significantly affecting pacemaker implantation, device fixation, or function.
- •NYHA functional class IV, or refractory heart failure, cardiogenic shock, rendering the patient unable to tolerate the procedure and perioperative management.
- •Severe hepatic or renal impairment (eGFR < 30 mL/min/1.73m², severe liver dysfunction), coagulopathy, or active bleeding disorders constituting clear surgical contraindications.
- •Confirmed allergy or severe intolerance to leadless pacemaker materials, intraoperative contrast media, or anesthetic agents.
- •Prior implantation of other cardiovascular implantable electronic devices (e.g., pacemaker, ICD, CRT) or retained intracardiac leads/devices that would interfere with the current implantation or device function.
- •Advanced malignancy, severe active infection, active autoimmune disease, or other serious systemic conditions with an expected survival < 12 months, precluding completion of the 3-month follow-up.
- •Pregnant or lactating women, or women planning pregnancy during the follow-up period.
- •Psychiatric disorders, cognitive impairment, or inability to cooperate with preoperative evaluation, intraoperative procedure, or regular postoperative follow-up due to personal or geographic reasons.
- •Concurrent participation in another cardiovascular device clinical trial that may interfere with the outcome assessment of this study.
- •Any other condition deemed by the investigator to make the participant unsuitable for enrollment.
研究组 & 干预措施
Experimental: Aveir VR Leadless Pacemaker
Participants will undergo transjugular implantation of the Aveir VR active-fixation leadless ventricular pacemaker. This experimental arm evaluates the procedure and device performance for ventricular pacing indications.
干预措施: Aveir VR Leadless Pacemaker (Device)
结局指标
主要结局
Rate of Participants with Sustained Successful Aveir VR Lead Implantation (evaluated by fluoroscopy and clinical-electrophysiological follow-up)
时间窗: Through 3 months post-procedure
The percentage of participants with sustained successful Aveir VR lead implantation via trans-jugular venous access at 3-month follow-up. Sustained implantation success is defined as intact lead position, stable pacing parameters, and absence of lead-related complications at the end of 3-month follow-up.
Acute adverse event rate
时间窗: Periprocedural and up to 48 hours
Incidence of adverse events within 48 hours post-procedure, measured as a percentage
次要结局
- Pacing Threshold (measured in volts)(Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure)
- R-wave amplitude(Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure)
- Lead impedance(Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure)
- Technical success rate(Periprocedural)
- Duration of the Implantation Procedure (measured in minutes)(Periprocedural)
- Fluoroscopy time(Periprocedural)
- Number of puncture attempts(Periprocedural)
- Number of lead fixation attempts(Periprocedural)
- Implantation site(Periprocedural)
- Correlation between site and parameters(Up to 3 months)
- Adverse event incidence(Through 3 months post-procedure)
- Serious adverse event incidence(Through 3 months post-procedure)
- Device-related complication rate(Through 3 months post-procedure)
研究者
Min Shen
Associate Chief Physician
Xijing Hospital