Heart DiseasesNCT06386458

Assessing AThrough Radiofrequency Transseptal Puncture System for Left Atrial Access

A study testing AThrough radiofrequency transseptal puncture system and Traditional mechanical transseptal puncture needle in people with Heart Diseases and Atrial Fibrillation, run by Hangzhou NOYA MedTech Co. Ltm. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Diseases, Atrial Fibrillation
What is being tested?: AThrough radiofrequency transseptal puncture system and Traditional mechanical transseptal puncture needle
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 177 participants
Where: 4 sitesChina
Study dates: 8 Jul 2022to 11 May 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
The 7th People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000

Other trials in China

About this study

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.

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
Being tested: AThrough radiofrequency transseptal puncture system, Traditional mechanical transseptal puncture needle
Medical subject headings: Heart Diseases, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AThrough radiofrequency transseptal puncture systemDevice
Utilizing AThrough radiofrequency transseptal puncture system for left atrial access
Traditional mechanical transseptal puncture needleDevice
Utilizing Traditional mechanical transseptal puncture needle for left atrial access

Study groups in NCT06386458
Study group	Role	What they receive
Radiofrequency transseptal puncture needle	Experimental	Utilizing Radiofrequency transseptal puncture system for left atrial access Receives: Device: AThrough radiofrequency transseptal puncture system
Traditional mechanical transseptal puncture needle	Active comparator	Utilizing Traditional mechanical transseptal puncture needle for left atrial access Receives: Device: Traditional mechanical transseptal puncture needle

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Intraprocedural assessment

Secondary outcomes (4)

Initial transseptal puncture success rate.
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.
Measured: Intraprocedural assessment
Time required to successfully complete the transseptal puncture.
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.
Measured: Intraprocedural assessment
Number of attempts needed to successfully complete the transseptal puncture.
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.
Measured: Intraprocedural assessment
Ratio of atrial septal puncture failures that cross over to the opposite group.
Ratio of atrial septal puncture failures that cross over to the opposite group;
Measured: Intraprocedural assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202211 May 2023

First posted26 Apr 2024
Study start8 Jul 2022
Primary completion9 May 2023
Study completion11 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Heart DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06386458
Sponsor's protocol ID: AT-01
Status last verified: Apr 2024
First submitted: 23 Apr 2024
Last updated: 26 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Heart Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT06386458
Acronym / sponsor ID: AT-01
Conditions: Heart Diseases, Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: Hangzhou NOYA MedTech Co. Ltm.Industry (pharma, biotech, devices)
Study start: 8 Jul 2022 (actual)
Primary completion: 9 May 2023 (actual)
Study completion: 11 May 2023 (actual)
First posted: 26 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Radiofrequency transseptal puncture needle	Experimental	Device: AThrough radiofrequency transseptal puncture systemUtilizing Radiofrequency transseptal puncture system for left atrial access
Traditional mechanical transseptal puncture needle	Active comparator	Device: Traditional mechanical transseptal puncture needleUtilizing Traditional mechanical transseptal puncture needle for left atrial access

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AThrough radiofrequency transseptal puncture systemUtilizing AThrough radiofrequency transseptal puncture system for left atrial access	Device	Radiofrequency transseptal puncture needle
Traditional mechanical transseptal puncture needleUtilizing Traditional mechanical transseptal puncture needle for left atrial access	Device	Traditional mechanical transseptal puncture needle

Primary outcome

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

4 secondary outcomes

Initial transseptal puncture success rate.
Time frame: Intraprocedural assessment
Time required to successfully complete the transseptal puncture.
Time frame: Intraprocedural assessment
Number of attempts needed to successfully complete the transseptal puncture.
Time frame: Intraprocedural assessment
Ratio of atrial septal puncture failures that cross over to the opposite group.
Time frame: Intraprocedural assessment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.

Related trials for Heart Diseases

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
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RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wei Sun, MD principal investigator

The First Affiliated Hospital with Nanjing Medical University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transseptal puncture success rate. (time frame: Intraprocedural assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06386458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.