BradycardiaNCT07802119
Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers
A study testing Aveir VR Leadless Pacemaker in people with Bradycardia and Heart Block, run by Min Shen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bradycardia, Heart Block, Sick Sinus Syndrome
- What is being tested?
- Aveir VR Leadless Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xijing Hospital, The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710032
Min Shen, MD, PhD, +86-18099773953, 261726782@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome, Atrioventricular Block
- Being tested
- Aveir VR Leadless Pacemaker
- Keywords
- Leadless pacemaker, Aveir VR, Transjugular approach, Ventricular pacing, Feasibility study
- Medical subject headings
- Bradycardia, Heart Block, Sick Sinus Syndrome, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aveir VR Leadless PacemakerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Aveir VR Leadless Pacemaker | Experimental | 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. Receives: Device: Aveir VR Leadless Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 3 months post-procedure
Acute adverse event rate
Incidence of adverse events within 48 hours post-procedure, measured as a percentage
Measured: Periprocedural and up to 48 hours
Secondary outcomes (13)
Pacing Threshold (measured in volts)
Pacing threshold of the Aveir VR lead, measured in volts, to evaluate threshold stability across follow-up time points.
Measured: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
R-wave amplitude
R-wave amplitude measured in millivolts.
Measured: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
Lead impedance
Lead impedance measured in ohms.
Measured: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
Technical success rate
Rate of technical success measured as a percentage.
Measured: Periprocedural
Duration of the Implantation Procedure (measured in minutes)
Total time duration of the leadless pacemaker implantation procedure, measured in minutes.
Measured: Periprocedural
Fluoroscopy time
Duration of fluoroscopy measured in minutes.
Measured: Periprocedural
Number of puncture attempts
Count of puncture attempts measured in number of times.
Measured: Periprocedural
Number of lead fixation attempts
Count of fixation attempts measured in number of times.
Measured: Periprocedural
Implantation site
Anatomical location of implantation recorded as a categorical variable.
Measured: Periprocedural
Correlation between site and parameters
Pacing parameters by site
Measured: Up to 3 months
Adverse event incidence
Overall incidence of adverse events measured as a percentage.
Measured: Through 3 months post-procedure
Serious adverse event incidence
Incidence of serious adverse events measured as a percentage.
Measured: Through 3 months post-procedure
Device-related complication rate
Rate of device-related complications measured as a percentage.
Measured: Through 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min Shen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min Shen, Xijing Hospital
- Investigators
- Min Shen, MD, PhD, Principal investigator, Department of Cardiovascular Medicine, First Affiliated Hospital of Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802119
- Sponsor's protocol ID
- KY20262201-F-1
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
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.
PubMed 41099983Saleem-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.
PubMed 36031774
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07802119
- Acronym / sponsor ID
- KY20262201-F-1
- Conditions
- Bradycardia, Heart Block, Sick Sinus Syndrome, Atrioventricular Block
- Keywords
- Leadless pacemaker, Aveir VR, Transjugular approach, Ventricular pacing, Feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Min ShenUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Aveir VR Leadless Pacemaker | Experimental | Device: Aveir VR Leadless PacemakerParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- Anatomical feasibility and vascular access assessment:
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aveir VR Leadless PacemakerThe 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. | Device | Experimental: Aveir VR Leadless Pacemaker |
Primary outcome
Rate of Participants with Sustained Successful Aveir VR Lead Implantation (evaluated by fluoroscopy and clinical-electrophysiological follow-up)
Time frame: 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
Time frame: Periprocedural and up to 48 hours
Incidence of adverse events within 48 hours post-procedure, measured as a percentage
13 secondary outcomes
Pacing Threshold (measured in volts)
Time frame: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
R-wave amplitude
Time frame: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
Lead impedance
Time frame: Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure
Technical success rate
Time frame: Periprocedural
Duration of the Implantation Procedure (measured in minutes)
Time frame: Periprocedural
Fluoroscopy time
Time frame: Periprocedural
Number of puncture attempts
Time frame: Periprocedural
Number of lead fixation attempts
Time frame: Periprocedural
Implantation site
Time frame: Periprocedural
Correlation between site and parameters
Time frame: Up to 3 months
Adverse event incidence
Time frame: Through 3 months post-procedure
Serious adverse event incidence
Time frame: Through 3 months post-procedure
Device-related complication rate
Time frame: Through 3 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 41099983Buchanan 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.
- Background: PubMed 36031774Saleem-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Shen, MD, PhD principal investigator
Department of Cardiovascular Medicine, First Affiliated Hospital of Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aveir VR Leadless Pacemaker in people with Bradycardia and Heart Block, run by Min Shen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Shen, MD, PhD (+86-18099773953, 261726782@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Participants with Sustained Successful Aveir VR Lead Implantation (evaluated by fluoroscopy and clinical-electrophysiological follow-up) (time frame: Through 3 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07802119, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.