Trials / Enrolling By Invitation
Enrolling By InvitationNCT06837870
Percutaneous Closure Versus Figure-of-eight Suture for Hemostasis in Leadless Pacemaker Implantation.
A Randomized Comparison of Percutaneous Closure to a Figure-of-eight Suture With Manual Compression for Hemostasis of Large-bore Access for Leadless Pacemaker Implantation
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- University of Massachusetts, Worcester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will be a randomized comparison of percutaneous suture-mediated closure (SMC) versus manual compression with a superficial figure-of-eight suture (MC) for large bore venous access used for leadless pacemaker implantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | percutaneous suture mediated closure | Vascular closure with a commercially available SMC device. |
| DEVICE | Figure of Eight Suture | Manual Compression with Figure of Eight Suture (control). |
Timeline
- Start date
- 2025-07-11
- Primary completion
- 2026-12-01
- Completion
- 2027-01-01
- First posted
- 2025-02-20
- Last updated
- 2026-03-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06837870. Inclusion in this directory is not an endorsement.