Evaluation of the Radiofrequency Transseptal Puncture SystemNCT06990230
Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul
A study testing Radiofrequency Transseptal Puncture System and Auxiliary Device in people with Evaluation of the Radiofrequency Transseptal Puncture System and Atrial Septum Puncture, run by First Affiliated Hospital of Ningbo University at 1 site in China.
Trial summary
To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum. Evaluation indicators: Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of the Radiofrequency Transseptal Puncture System, Atrial Septum Puncture
- What is being tested?
- Radiofrequency Transseptal Puncture System and Auxiliary Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2024to 30 Sep 2024
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants scheduled to undergo transseptal access interventional cardiology procedure; The subjects were informed of the nature of the study, understood the purpose of the clinical trial, voluntarily participated and signed an informed consent form.
Who cannot join
- The presence of an intracardiac mass, thrombus or vegetation on echocardiography; Left atrial myxoma;
- subjects with ASD occluder or patch implantation;
- hemorrhagic or coagulopathy; Or there is contraindication to antithrombotic drugs;
- acute myocardial infarction within 4 weeks;
- end-stage heart failure (ACC/AHAD stage); Or after heart transplantation; Or waiting for a heart transplant;
- history of cerebrovascular accident within 30 days;
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- pregnant and lactating women;
- acute systemic infection or sepsis;
- patients who have participated in any drug and/or medical device clinical trial within 1 month before this trial;
- atrial septal puncture within 3 months;
- life expectancy less than one year;
- The investigator judged that the patient had poor compliance and could not complete the study according to the requirements; Or other circumstances in which the researcher considers the subject to be unsuitable for the study
Trial locations and contacts
1 site in 1 country.
China1 site
Heayoung Medical Technology (Suzhou) Co., Ltd
Suzhou, Jiangsu, 215000
About this study
To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum.
Evaluation indicators:
Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the contralateral group; Performance evaluation of an RF transseptal puncture system; The incidence of complications related to atrial septal puncture; Rates of adverse events; Rates of serious adverse events.
- Being tested
- Radiofrequency Transseptal Puncture System and Auxiliary Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Transseptal Puncture System and Auxiliary DeviceDevice
The intervention in this study stands out due to its specific focus on evaluating the safety and efficacy of a radiofrequency transseptal puncture system designed exclusively for use in the atrial septum, with the purpose of establishing a passage from the right atrium to the left atrium. This system incorporates an auxiliary radiofrequency puncture device, which serves as a crucial supportive component, enhancing the overall functionality and precision of the primary transseptal puncture system.
What further distinguishes this intervention from others is its utilization of radiofrequency energy to facilitate the transseptal puncture. Unlike traditional mechanical puncture methods, which can have a steep learning curve, potentially cause serious complications such as pericardial tamponade and cardiac rupture, and may be time-consuming and imprecise in predicting the puncture site, the radiofrequency puncture device provides a more controlled and predictable approach. The radiofrequenc
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | RF Cross Receives: Device: Radiofrequency Transseptal Puncture System and Auxiliary Device |
| Control Group | Active comparator | Braidin Cross Receives: Device: Radiofrequency Transseptal Puncture System and Auxiliary Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of atrial septum
Measured: It is expected to last 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start27 May 2024
- Primary completion17 Jul 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of the Radiofrequency Transseptal Puncture SystemStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Yibo Yu, First Affiliated Hospital of Ningbo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990230
- Sponsor's protocol ID
- RF20240131
- Other IDs
- FAHNBU20240581
- Status last verified
- May 2025
- First submitted
- 10 Mar 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul
- ClinicalTrials.gov ID
- NCT06990230
- Acronym / sponsor ID
- RF20240131
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Ningbo UniversityResearch network
- Study start
- 27 May 2024 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 25 May 2025 (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.
To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum.
Evaluation indicators:
Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the contralateral group; Performance evaluation of an RF transseptal puncture system; The incidence of complications related to atrial septal puncture; Rates of adverse events; Rates of serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Radiofrequency Transseptal Puncture System and Auxiliary DeviceRF Cross |
| Control Group | Active comparator | Device: Radiofrequency Transseptal Puncture System and Auxiliary DeviceBraidin Cross |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants scheduled to undergo transseptal access interventional cardiology procedure; The subjects were informed of the nature of the study, understood the purpose of the clinical trial, voluntarily participated and signed an informed consent form.
Key exclusion criteria (12 listed)
- The presence of an intracardiac mass, thrombus or vegetation on echocardiography; Left atrial myxoma;
- subjects with ASD occluder or patch implantation;
- hemorrhagic or coagulopathy; Or there is contraindication to antithrombotic drugs;
- acute myocardial infarction within 4 weeks;
- end-stage heart failure (ACC/AHAD stage); Or after heart transplantation; Or waiting for a 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 |
|---|---|---|
| Radiofrequency Transseptal Puncture System and Auxiliary DeviceThe intervention in this study stands out due to its specific focus on evaluating the safety and efficacy of a radiofrequency transseptal puncture system designed exclusively for use in the atrial septum, with the purpose of establishing a passage from the right atrium to the left atrium. This system incorporates an auxiliary radiofrequency puncture device, which serves as a crucial supportive component, enhancing the overall functionality and precision of the primary transseptal puncture system. What further distinguishes this intervention from others is its utilization of radiofrequency energy to facilitate the transseptal puncture. Unlike traditional mechanical puncture methods, which can have a steep learning curve, potentially cause serious complications such as pericardial tamponade and cardiac rupture, and may be time-consuming and imprecise in predicting the puncture site, the radiofrequency puncture device provides a more controlled and predictable approach. The radiofrequenc | Device | Control Group, Test Group |
Primary outcome
Success rate of atrial septum
Time frame: It is expected to last 18 months
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 25 May 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Transseptal Puncture System and Auxiliary Device in people with Evaluation of the Radiofrequency Transseptal Puncture System and Atrial Septum Puncture, run by First Affiliated Hospital of Ningbo University at 1 site in China.
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 1 inclusion and 12 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Success rate of atrial septum (time frame: It is expected to last 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2025.