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NOT YET RECRUITING
NCT07802119
NA

Transjugular Approach for Implantation of Active Fixation Leadless Pacemakers

Sponsor: Min Shen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-09-10

Completion Date

2027-12-31

Last Updated

2026-09-03

Healthy Volunteers

No

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.

Locations (1)

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

Xi'an, Shaanxi, China