Clinical trial NCT06386458: Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Atrial Fibrillation
Lead sponsor: Hangzhou NOYA MedTech Co. Ltm.
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patient age ≥ 18 years;
2. Subjects scheduled to undergo cardiology interventional treatment via the transseptal puncture route;
3. Subjects have been informed about the nature of the study, understand the purpose of the clinical trial, and voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. Echocardiogram indicates the presence of intracardiac masses, thrombi, or vegetations; left atrial myxoma;
2. Subjects with an atrial septal defect occluder or atrial septal patch implant;
3. Hemorrhagic disease or coagulopathy; or contraindications to antithrombotic medication treatment;
4. Acute myocardial infarction occurred within the last 4 weeks;
5. End-stage heart failure (ACC/AHA stage D); post-heart transplant; or awaiting heart transplant;
6. Pregnant or breastfeeding women;
7. Acute systemic infection or sepsis;
8. Participation in any drug and/or medical device clinical trial within the last month;
9. Researchers judge the patient's compliance to be poor, unable to complete the study as required; or other situations deemed by the researchers as making the subject unsuitable for participation in the study.

Primary outcomes:
measure: Transseptal puncture success rate.
timeFrame: Intraprocedural assessment
Secondary outcomes:
measure: Initial transseptal puncture success rate.
timeFrame: Intraprocedural assessment
measure: Time required to successfully complete the transseptal puncture.
timeFrame: Intraprocedural assessment
measure: Number of attempts needed to successfully complete the transseptal puncture.
timeFrame: Intraprocedural assessment
measure: Ratio of atrial septal puncture failures that cross over to the opposite group.
timeFrame: Intraprocedural assessment
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The 7th People's Hospital of Zhengzhou
state: Henan
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Wei Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: