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NCT06990230
Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul
NA trial testing Radiofrequency Transseptal Puncture System and Auxiliary Device in Evaluation of the Radiofrequency Transseptal Puncture System in 180 participants. Completed in 30 September 2024.
17 July 2024
Quick facts
| Lead sponsor | First Affiliated Hospital of Ningbo University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 27 May 2024 |
| Primary completion | 17 July 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Radiofrequency Transseptal Puncture System and Auxiliary Device
Conditions studied
- Evaluation of the Radiofrequency Transseptal Puncture System — all drugs for Evaluation of the Radiofrequency Transseptal Puncture System →
- Atrial Septum Puncture — all drugs for Atrial Septum Puncture →
Sponsor
First Affiliated Hospital of Ningbo University
Who can join
Adults 18 to 80, any sex, with Evaluation of the Radiofrequency Transseptal Puncture System or Atrial Septum Puncture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum. Evaluation indicators: Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the contralateral group; Performance evaluation of an RF transseptal puncture system; The incidence of complications related to atrial septal puncture; Rates of adverse events; Rates of serious adverse events.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06990230
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06990230 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by First Affiliated Hospital of Ningbo University
- Last refreshed: 25 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06990230.
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