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Clinical Applicability, Efficacy and Safety of a Novel Anatomical Landmark-Guided Blind Puncture Technique for Axillary Vein Access in Pacemaker Implantation Procedures

Clinical Applicability, Efficacy and Safety of a Novel Anatomical Landmark-Guided Blind Puncture Technique for Axillary Vein Access in Pacemaker Implantation Procedures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113976
Enrollment
Unknown
Registered
2025-12-04
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

nAVP group:nAVP Procedure:The operator performs the puncture using the nAVP technique. During the procedure, all relevant parameters are recorded. Postoperatively, the patient is observed for any adve
SVP group:SVP Procedure: The operator performs the puncture using the traditional SVP technique. During the procedure, all relevant parameters are recorded. Postoperatively, the patient is observed fo

Sponsors

the First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years. 2. Subjects requiring pacemaker (PM) implantation for diagnostic or therapeutic purposes. 3. Subjects or their legally authorized representatives must be competent to understand the purpose, procedures, risks, and benefits of the trial, and voluntarily provide written informed consent. 4. Subjects must have stable resting vital signs:Resting heart rate: 60 - 150 beats per minute Blood pressure:Systolic: 90 - 200 mmHg Diastolic: 60 - 150 mmHg Respiratory rate: 12 - 30 breaths per minute 5. The subject's underlying disease(s) must be in a relatively stable phase, without acute exacerbation or severe complications requiring urgent intervention.

Exclusion criteria

Exclusion criteria: 1. Infection at the puncture site 2. Coagulation dysfunction: Presence of severe impairment in coagulation function 3. Anatomic abnormalities at the puncture site 4. Hypersensitivity to trial-related materials (e.g., contrast agents, antiseptic solutions) 5. Inability to cooperate with procedures due to severe psychiatric disorders or impaired consciousness 6. Subjects with incomplete clinical documentation or premature withdrawal during follow-up 7. Other conditions potentially compromising procedural safety or elevating complication risks

Design outcomes

Primary

MeasureTime frame
Puncture success rate;

Secondary

MeasureTime frame
Time to venous access;Time from venous access to skin closure;Total procedure duration;Fluoroscopy time;X-ray Radiation Dose;First-Attempt Success Rate;Number of Puncture Attempts;

Countries

China

Contacts

Public ContactXu Longwei

the First Affiliated Hospital of Zhengzhou University

dr_xlw@hotmail.com+86 152 3831 1898

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026