Skip to content

Clinical Trial for Safety and Effectiveness of TranseeTM Atrial Septal Puncture System

Clinical Trial for Safety and Effectiveness of TranseeTM Atrial Septal Puncture System

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021933
Enrollment
Unknown
Registered
2019-03-16
Start date
2019-04-01
Completion date
Unknown
Last updated
2019-03-18

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

Conditions

atrial fibrillation

Interventions

experimental group:Atrial septal puncture
control group:Atrial septal puncture

Sponsors

Changhai Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) The patient was diagnosed as atrial fibrillation; 2) Radiofrequency catheter ablation for atrial fibrillation; 3) Aged 18 to 75 years; 4) The patient or his legal representative sign the informed consent approved by the ethics committee.

Exclusion criteria

Exclusion criteria: 1) Atrial septal defect occluder or atrial septal patch implant; 2) Thrombus in left atrium; 3) Acute or severe systemic infection; 4) Patients with left atrial myxoma; 5) Myocardial infarction in the last two weeks; 6) Cerebral Vascular Accident (CVA) occurred in the last three months. 7) Cardiac function (NYHA grade) IV; 8) Atrial septal puncture was performed; 9) Patients in any other condition considered inappropriate for this trial by some researchers.

Design outcomes

Primary

MeasureTime frame
Success rate of atrial septal puncture;

Secondary

MeasureTime frame
Interatrial septal puncture time;Total operative fluoroscopy time;To evaluate the success rate of instrumental surgery;Successful operation at discharge;Performance evaluation of atrial septal puncture needle;Performance evaluation of atrial septal puncture sheath;

Countries

China

Contacts

Public ContactJiang Cao

Changhai Hospital of Shanghai

caojohny@hotmail.com+86 13816114576

Outcome results

None listed

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