Atrioventricular Block, Bradycardia, Heart Block, Sick Sinus Syndrome
Conditions
Keywords
Leadless pacemaker, Aveir VR, Transjugular approach, Ventricular pacing, Feasibility study
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAveir VR Leadless Pacemaker
The Aveir VR leadless pacemaker is implanted via a transjugular (jugular vein) approach. This active-fixation device is placed in the right ventricle for ventricular pacing indications.
Sponsors
Min Shen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-group, open-label feasibility study. All enrolled participants will undergo implantation of the Aveir VR leadless pacemaker via the transjugular approach. There is no control group or randomization; all subjects receive the same intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 85 years, regardless of gender. 2. 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. 3. 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). 4. New York Heart Association (NYHA) functional class ≤ III, and expected survival \> 1 year. 5. Able to cooperate with preoperative evaluation, intraoperative procedure, and 3-month follow-up. 6. Voluntarily signs written informed consent and agrees to complete all scheduled observations per the study protocol.
Exclusion criteria
1. Anatomical malformations, severe stenosis, occlusion, or thrombosis of the internal jugular vein or superior vena cava that preclude transjugular access for the procedure. 2. 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. 3. Severe tricuspid regurgitation, or status post-mechanical tricuspid valve replacement, significantly affecting pacemaker implantation, device fixation, or function. 4. NYHA functional class IV, or refractory heart failure, cardiogenic shock, rendering the patient unable to tolerate the procedure and perioperative management. 5. Severe hepatic or renal impairment (eGFR \< 30 mL/min/1.73m², severe liver dysfunction), coagulopathy, or active bleeding disorders constituting clear surgical contraindications. 6. Confirmed allergy or severe intolerance to leadless pacemaker materials, intraoperative contrast media, or anesthetic agents. 7. 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. 8. 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. 9. Pregnant or lactating women, or women planning pregnancy during the follow-up period. 10. Psychiatric disorders, cognitive impairment, or inability to cooperate with preoperative evaluation, intraoperative procedure, or regular postoperative follow-up due to personal or geographic reasons. 11. Concurrent participation in another cardiovascular device clinical trial that may interfere with the outcome assessment of this study. 12. Any other condition deemed by the investigator to make the participant unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants with Sustained Successful Aveir VR Lead Implantation (evaluated by fluoroscopy and clinical-electrophysiological follow-up) | 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 | Periprocedural and up to 48 hours | Incidence of adverse events within 48 hours post-procedure, measured as a percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pacing Threshold (measured in volts) | Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure | Pacing threshold of the Aveir VR lead, measured in volts, to evaluate threshold stability across follow-up time points. |
| R-wave amplitude | Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure | R-wave amplitude measured in millivolts. |
| Lead impedance | Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure | Lead impedance measured in ohms. |
| Technical success rate | Periprocedural | Rate of technical success measured as a percentage. |
| Duration of the Implantation Procedure (measured in minutes) | Periprocedural | Total time duration of the leadless pacemaker implantation procedure, measured in minutes. |
| Fluoroscopy time | Periprocedural | Duration of fluoroscopy measured in minutes. |
| Number of puncture attempts | Periprocedural | Count of puncture attempts measured in number of times. |
| Number of lead fixation attempts | Periprocedural | Count of fixation attempts measured in number of times. |
| Implantation site | Periprocedural | Anatomical location of implantation recorded as a categorical variable. |
| Correlation between site and parameters | Up to 3 months | Pacing parameters by site |
| Adverse event incidence | Through 3 months post-procedure | Overall incidence of adverse events measured as a percentage. |
| Serious adverse event incidence | Through 3 months post-procedure | Incidence of serious adverse events measured as a percentage. |
| Device-related complication rate | Through 3 months post-procedure | Rate of device-related complications measured as a percentage. |
Countries
China
Contacts
CONTACTMin Shen, MD, PhD
PRINCIPAL_INVESTIGATORMin Shen, MD, PhD
Department of Cardiovascular Medicine, First Affiliated Hospital of Air Force Medical University
Outcome results
None listed