Trials / Completed
CompletedNCT06386458
Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access
A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Study Evaluating the Safety and Efficacy of the AThrough Radiofrequency Transseptal Puncture System in Atrial Septal Puncture.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 177 (actual)
- Sponsor
- Hangzhou NOYA MedTech Co. Ltm. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, multicenter, randomized controlled trial with a non-inferiority design. Participants are patients scheduled for atrial septal puncture. After signing informed consent, subjects will be randomly assigned to either the radiofrequency transseptal puncture system group (referred to as the trial group) or the traditional mechanical transseptal puncture system group (referred to as the control group). All participants will undergo immediate postoperative and discharge clinical follow-ups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AThrough radiofrequency transseptal puncture system | Utilizing AThrough radiofrequency transseptal puncture system for left atrial access |
| DEVICE | Traditional mechanical transseptal puncture needle | Utilizing Traditional mechanical transseptal puncture needle for left atrial access |
Timeline
- Start date
- 2022-07-08
- Primary completion
- 2023-05-09
- Completion
- 2023-05-11
- First posted
- 2024-04-26
- Last updated
- 2024-04-26
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06386458. Inclusion in this directory is not an endorsement.