Skip to content

A Comparative Study of a Novel Venous Hemostasis Device Utilizing Collagen Patches and the Figure-of-Eight Suture Hemostasis.

Prospective Single-Center Randomized Study Comparing Collagen-Based Local Hemostatic Agent with Figure-of-Eight Suture Hemostasis in Femoral Vein Hemorrhage Control. - Prospective Single-Center Randomized Study Comparing Collagen-Based Local Hemostatic Agent with Figure-of-Eight Suture Hemostasis.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052235
Enrollment
44
Registered
2023-12-01
Start date
2023-11-20
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Arrhythmia

Interventions

A new venous disclosure system. Figure eight suture hemostasis.

Sponsors

Tokyo Medical and Dental University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have undergone cardiac catheter ablation using sheaths with an inner diameter ranging from 6-12 French (maximum outer diameter of 15 French), and who are 20 years of age or older and capable of providing informed consent in writing.

Exclusion criteria

Exclusion criteria: History of previous use of femoral vein hemostasis device (leaving permanent sutures or metal clips). History of allergy to bovine-derived components. History of femoral vein stent placement. If physicians deem the case inappropriate.

Design outcomes

Primary

MeasureTime frame
Time to ambulation (time from sheath removal to the initiation of walking without rebleeding). Time to hemostasis (time from sheath removal until hemostasis is achieved even with manual pressure discontinued). Procedural success rate (successful achievement of ambulation at the scheduled time per patient without complications).

Countries

Japan

Contacts

Public ContactKentaro Goto

Tokyo Medical and Dental University Hospital Department of Cardiovascular Medicine, Advanced Arrhythmia Research.

kentaro-goto.cvm@tmd.ac.jp03-5803-5231

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026