Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

NCT06386458 | Completed

• 1 other identifier: AT-01
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Transseptal puncture success rate.

  Defined as successfully completing the puncture in the atrial septum and establishing a pathway from the right atrium to the left atrium (with the sheath entering the left atrium) using the transseptal puncture system

  Intraprocedural assessment

Secondary Outcomes (4)

• Initial transseptal puncture success rate.

  Intraprocedural assessment

• Time required to successfully complete the transseptal puncture.

  Intraprocedural assessment

• Number of attempts needed to successfully complete the transseptal puncture.

  Intraprocedural assessment

• Ratio of atrial septal puncture failures that cross over to the opposite group.

  Intraprocedural assessment

Study Arms (2)

Radiofrequency transseptal puncture needle

EXPERIMENTAL

Utilizing Radiofrequency transseptal puncture system for left atrial access

Device: AThrough radiofrequency transseptal puncture system

Traditional mechanical transseptal puncture needle

ACTIVE COMPARATOR

Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Device: Traditional mechanical transseptal puncture needle

Interventions

AThrough radiofrequency transseptal puncture system DEVICE

Utilizing AThrough radiofrequency transseptal puncture system for left atrial access

Radiofrequency transseptal puncture needle

Traditional mechanical transseptal puncture needle DEVICE

Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Traditional mechanical transseptal puncture needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age ≥ 18 years;
• Subjects scheduled to undergo cardiology interventional treatment via the transseptal puncture route;
• 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.

You may not qualify if:

• Echocardiogram indicates the presence of intracardiac masses, thrombi, or vegetations; left atrial myxoma;
• Subjects with an atrial septal defect occluder or atrial septal patch implant;
• Hemorrhagic disease or coagulopathy; or contraindications to antithrombotic medication treatment;
• Acute myocardial infarction occurred within the last 4 weeks;
• End-stage heart failure (ACC/AHA stage D); post-heart transplant; or awaiting heart transplant;
• Pregnant or breastfeeding women;
• Acute systemic infection or sepsis;
• Participation in any drug and/or medical device clinical trial within the last month;
• 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.

Sponsors & Collaborators

• Hangzhou NOYA MedTech Co. Ltm.: lead

Study Sites (4)

The 7th People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

Location

MeSH Terms

Conditions

Heart Diseases; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Sun, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: July 8, 2022
• Primary Completion: May 9, 2023
• Study Completion: May 11, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CN (4)