Can a pacemaker slip in through the neck vein?

NCT ID NCT07802119

Disease control Sponsor: Min Shen Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
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First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This trial tests whether a small leadless pacemaker, the Aveir VR, can be safely implanted through the jugular vein in the neck instead of the usual route. Researchers will enroll 15 adults with slow heart rhythms who need ventricular pacing. The main goal is to see if the procedure works and is safe within the first 48 hours, and whether the pacemaker stays stable over three months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Aveir VR leadless pacemaker implanted via the jugular vein
What this could lead to
If successful, this approach could offer a safer, less invasive way to implant leadless pacemakers, potentially expanding options for patients with limited access routes.
What could go wrong
This is a small, early feasibility study with only 15 participants, so results may not apply broadly. Risks include procedural complications, lead dislodgement, or unstable pacing parameters.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Xijing Hospital, The First Affiliated Hospital of Air Force Medical University

    Xi'an, Shaanxi, 710032, China

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