Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

NCT ID: NCT06386458

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2023-05-11

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.

Conditions

Heart Diseases; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiofrequency transseptal puncture needle

Utilizing Radiofrequency transseptal puncture system for left atrial access

Group Type: EXPERIMENTAL

AThrough radiofrequency transseptal puncture system

Intervention Type: DEVICE

Utilizing AThrough radiofrequency transseptal puncture system for left atrial access

Traditional mechanical transseptal puncture needle

Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Group Type: ACTIVE_COMPARATOR

Traditional mechanical transseptal puncture needle

Intervention Type: DEVICE

Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Interventions

AThrough radiofrequency transseptal puncture system

Utilizing AThrough radiofrequency transseptal puncture system for left atrial access

Intervention Type: DEVICE

Traditional mechanical transseptal puncture needle

Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou NOYA MedTech Co. Ltm.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Sun, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The 7th People's Hospital of Zhengzhou

Zhengzhou, Henan, China

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Countries

China

Other Identifiers

AT-01

Identifier Type: -

Identifier Source: org_study_id