Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMin Shen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 85 years, regardless of gender.
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;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Aveir VR Leadless Pacemaker
DeviceThe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Experimental: Aveir VR Leadless PacemakerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-procedure2
Acute adverse event rate
Incidence of adverse events within 48 hours post-procedure, measured as a percentage
Time frame
Periprocedural and up to 48 hoursSecondary outcomes
1
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-procedure2
R-wave amplitude
R-wave amplitude measured in millivolts.
Time frame
Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure3
Lead impedance
Lead impedance measured in ohms.
Time frame
Baseline, Post-procedure Day 1-3, 1 month, and 3 months post-procedure4
Technical success rate
Rate of technical success measured as a percentage.
Time frame
PeriproceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Min Shen
Lead sponsor
Xijing Hospital
Sponsor institution
Source ClinicalTrials.gov
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