MedTrace Logo

Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers

NCT07802119 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-09-03

No results posted yet for this study

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. 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.

Conditions

  • Bradycardia
  • Heart Block
  • Sick Sinus Syndrome
  • Atrioventricular Block

Interventions

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.

Sponsors & Collaborators

  • Min Shen

    lead OTHER

Principal Investigators

  • Min Shen, MD, PhD · Department of Cardiovascular Medicine, First Affiliated Hospital of Air Force Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-10
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07802119 on ClinicalTrials.gov