Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers

Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers: A Feasibility Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Block; Bradycardia; Atrioventricular Block; Sick Sinus Syndrome
• Intervention / Treatment: Device: Aveir VR Leadless Pacemaker

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Shen, MD, PhD; Phone Number: +86-18099773953; Email: 261726782@qq.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital, The First Affiliated Hospital of Air Force Medical University
      • Contact: Min Shen, MD, PhD; Phone Number: +86-18099773953; Email: 261726782@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Aveir 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through 3 months post-procedure
Acute adverse event rate	Incidence of adverse events within 48 hours post-procedure, measured as a percentage	Periprocedural and up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pacing Threshold (measured in volts)	Pacing threshold of the Aveir VR lead, measured in volts, to evaluate threshold stability across follow-up time points.	Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
R-wave amplitude	R-wave amplitude measured in millivolts.	Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
Lead impedance	Lead impedance measured in ohms.	Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
Technical success rate	Rate of technical success measured as a percentage.	Periprocedural
Duration of the Implantation Procedure (measured in minutes)	Total time duration of the leadless pacemaker implantation procedure, measured in minutes.	Periprocedural
Fluoroscopy time	Duration of fluoroscopy measured in minutes.	Periprocedural
Number of puncture attempts	Count of puncture attempts measured in number of times.	Periprocedural
Number of lead fixation attempts	Count of fixation attempts measured in number of times.	Periprocedural
Implantation site	Anatomical location of implantation recorded as a categorical variable.	Periprocedural
Correlation between site and parameters	Pacing parameters by site	Up to 3 months
Adverse event incidence	Overall incidence of adverse events measured as a percentage.	Through 3 months post-procedure
Serious adverse event incidence	Incidence of serious adverse events measured as a percentage.	Through 3 months post-procedure
Device-related complication rate	Rate of device-related complications measured as a percentage.	Through 3 months post-procedure

Collaborators and Investigators

• Sponsor: Min Shen
• Investigators: Principal Investigator: Min Shen, MD, PhD, Department of Cardiovascular Medicine, First Affiliated Hospital of Air Force Medical University

Publications and helpful links

General Publications

• Buchanan EB, Suresh SP, Waseem N, Paul G, Yoo D. Initial experience utilizing the right internal jugular vein access for implantation of retrievable leadless pacemakers: safety, efficacy, and efficiency. J Interv Card Electrophysiol. 2026 Jan;69(1):143-148. doi: 10.1007/s10840-025-02135-3. Epub 2025 Oct 16.
• Saleem-Talib S, van Driel VJ, Nikolic T, van Wessel H, Louman H, Borleffs CJW, van der Heijden J, Cox M, Ramanna H. The jugular approach for leadless pacing: A novel and safe alternative. Pacing Clin Electrophysiol. 2022 Oct;45(10):1248-1254. doi: 10.1111/pace.14587. Epub 2022 Sep 12.

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 21, 2026
• First Submitted That Met QC Criteria: August 30, 2026
• First Posted (Actual): September 3, 2026

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: August 30, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Ventricular pacing; Feasibility study; Leadless pacemaker; Aveir VR; Transjugular approach
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Arrhythmia, Sinus; Pathological Conditions, Signs and Symptoms; Atrioventricular Block; Sick Sinus Syndrome; Bradycardia; Heart Block
• Other Study ID Numbers: KY20262201-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: his is a single-center feasibility study with a small sample size (n=15). Data sharing is not planned due to the limited statistical power and the difficulty in de-identifying such specific clinical data without undue risk.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes