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Completed

NCT Number: NCT06386458

Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

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.

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Key information

Conditions

Heart Diseases Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 7th People's Hospital of Zhengzhou, Zhengzhou, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

AThrough radiofrequency transseptal puncture system

Device

Utilizing AThrough radiofrequency transseptal puncture system for left atrial access

Traditional mechanical transseptal puncture needle

Device

Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Primary outcomes

  1. Transseptal puncture success rate.

    Time frame: Intraprocedural assessment

    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

Secondary outcomes

  1. Initial transseptal puncture success rate.

    Time frame: Intraprocedural assessment

    Defined as the period from the introduction of the transseptal puncture system into the femoral vein to the entry of transseptal sheath into the left atrium.

  2. Time required to successfully complete the transseptal puncture.

    Time frame: Intraprocedural assessment

    Defined as the time from when the transseptal puncture system is introduced into the femoral vein to when the transseptal sheath enters the left atrium.

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

    Time frame: Intraprocedural assessment

    During the transseptal puncture process, if the transseptal puncture system needs to be readjusted upwards and repositioned for oval fossa puncture, each readjustment should count as an additional attempt.

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

    Time frame: Intraprocedural assessment

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

Sponsors and collaborators

Lead sponsor

Hangzhou NOYA MedTech Co. Ltm.

Industry

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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