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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Xijing Hospital, The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
Rate of Participants with Sustained Successful Aveir VR Lead Implantation (evaluated by fluoroscopy and clinical-electrophysiological follow-up)
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.
Time frame: Through 3 months post-procedure
Acute adverse event rate
Incidence of adverse events within 48 hours post-procedure, measured as a percentage
Time frame: Periprocedural and up to 48 hours
Pacing Threshold (measured in volts)
Pacing threshold of the Aveir VR lead, measured in volts, to evaluate threshold stability across follow-up time points.
Time frame: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
R-wave amplitude
R-wave amplitude measured in millivolts.
Time frame: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
Lead impedance
Lead impedance measured in ohms.
Time frame: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
Technical success rate
Rate of technical success measured as a percentage.
Time frame: Periprocedural
Duration of the Implantation Procedure (measured in minutes)
Total time duration of the leadless pacemaker implantation procedure, measured in minutes.
Time frame: Periprocedural
Fluoroscopy time
Duration of fluoroscopy measured in minutes.
Time frame: Periprocedural
Number of puncture attempts
Count of puncture attempts measured in number of times.
Time frame: Periprocedural
Number of lead fixation attempts
Count of fixation attempts measured in number of times.
Time frame: Periprocedural
Implantation site
Anatomical location of implantation recorded as a categorical variable.
Time frame: Periprocedural
Correlation between site and parameters
Pacing parameters by site
Time frame: Up to 3 months
Adverse event incidence
Overall incidence of adverse events measured as a percentage.
Time frame: Through 3 months post-procedure
Serious adverse event incidence
Incidence of serious adverse events measured as a percentage.
Time frame: Through 3 months post-procedure
Device-related complication rate
Rate of device-related complications measured as a percentage.
Time frame: Through 3 months post-procedure
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