Atrial FibrillationNCT06188351
Three Dimensional Navigation IntraCardiac Guidance Kit for Atrial Septal Puncture
A study testing Three-Dimensional Navigation Atrial Septal Puncture and Conventional Atrial Septal Puncture in people with Atrial Fibrillation, run by Tongji Hospital at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of a three-dimensional navigation intracardiac guidance kit to perform atrial septal puncture in patients requiring catheter ablation, which will be compared with procedures using traditional kit for atrial septal puncture. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Three-Dimensional Navigation Atrial Septal Puncture and Conventional Atrial Septal Puncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2023to 1 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with atrial fibrillation.
- Requiring catheter ablation therapy.
- Voluntarily sign the informed consent.
Who cannot join
- Previous atrial septal puncture.
- Blood clots in the left atrium or left atrial appendage
- Left atrial mucinous tumor.
- Atrial septal defect, including previous surgical correction or interventional occlusion.
- Acute or severe systemic infection.
- Cardiac function (NYHA classification) Ⅲ-Ⅳ.
Show all 14Show fewer
- Contraindications to anticoagulation.
- Left ventricular ejection fraction <35%.
- Patients with untreated or uncontrolled hyperthyroidism or hypothyroidism.
- Patients with malignancy with expected survival of less than 1 year.
- Myocardial infarction or any cardiac intervention or open procedure within the last 3 months
- Stroke and other cerebrovascular disease or thromboembolic disease within the last 3 months.
- Participated in clinical trials of other drugs or devices in the past 3 months.
- Any other condition that the investigator deems inappropriate for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Yan Wang, PhD, +86-13697326307, newswangyan@tjh.tjmu.edu.cn
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture
This study aims to evaluate the safety and efficacy of a three-dimensional navigation intracardiac guidance kit to perform atrial septal puncture in patients requiring catheter ablation, which will be compared with procedures using traditional kit for atrial septal puncture.
Read the detailed description
Atrial septal puncture has become a key technique in cardiac interventional procedures. Traditional septal punctures are routinely perfomed under two-dimensioanl guidance, whic are likely to be not acurate sometimes.
This study is aimed to study the safety and efficacy of a novel designed three-dimensional navigation Intracardiac guidance kit for atrial septal puncture in patients with atrial fibrillation requiring catheter ablation and to explore the possibility of transseptal without fluoroscopy using the three-dimensional positioning intracardiac guidance.
- Conditions
- Atrial Fibrillation
- Being tested
- Three-Dimensional Navigation Atrial Septal Puncture, Conventional Atrial Septal Puncture
- Keywords
- Atrial septal puncture, Three dimensional, fluroscopy, Catheter Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Navigation Atrial Septal PunctureDevice
Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit
Conventional Atrial Septal PunctureDevice
Atrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method.
| Study group | Role | What they receive |
|---|---|---|
| Three-Dimensional Navigation Atrial Septal Puncture | Experimental | Atrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit Receives: Device: Three-Dimensional Navigation Atrial Septal Puncture |
| Conventional Atrial Septal Puncture | Active comparator | Atrial septal puncture will be performed using trational atrial septal puncture kit using traditional method. Receives: Device: Conventional Atrial Septal Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of atrial septal puncture
Successful atrial septal puncture is defined as the right and left interatrial pathways are established and the ablation catheter can enter the left atrium smoothly for subsequent ablation operations.
Measured: one day
X-Ray exposure time
X-ray exposure time from the successful femoral vein puncture to the entry of the external sheath into the left atrium (ending with heparin saline flushing of the sheath).
Measured: one day
Secondary outcomes (4)
First puncture success rate of atrial septum
When the first septal puncture is performed, the puncture sheath is passed through the septal puncture from the right atrium into the left atrium.
Measured: one day
Atrial septal puncture duration
Time taken from the time the puncture needle enters the dilator to the time when heparin saline is applied to flush the sheath after the external sheath enters the left atrium.
Measured: one day
Total operation time
Time taken from the start of successful femoral vein puncture to the entry of the external sheath into the left atrium (ending with heparin saline flushing of the sheath).
Measured: one day
Performance evaluation of a three-dimensional positioning intracardiac guidance kit
The investigators evaluated the products in terms of pushing performance, retraction performance, torsional control performance, bending resistance/kinking resistance in dilator, catheter sheath, and blood; and tracking performance of the guidewire, catheter sheath, and puncture needle in the 3D calibration system, respectively.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start24 Apr 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Greenrhythm Medical Technology Co., LTD
- Responsible party
- Principal investigator, Yan Wang, Tongji Hospital
- Investigators
- Yan Wang, PhD, Principal investigator, Tongji Hospital Wuhan, Hubei China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188351
- Sponsor's protocol ID
- 3DASP study
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yu R, Liu N, Lu J, Zhao X, Hu Y, Zhang J, Xu F, Tang R, Bai R, Akar JG, Dong J, Ma C. 3-Dimensional Transseptal Puncture Based on Electrographic Characteristics of Fossa Ovalis: A Fluoroscopy-Free and Echocardiography-Free Method. JACC Cardiovasc Interv. 2020 May 25;13(10):1223-1232. doi: 10.1016/j.jcin.2020.03.015.
PubMed 32438994Graham AJ, Honarbakhsh S, O'Brien B, Schilling RJ. A Simplified Trans-Septal Puncture Technique using a Needle Free Approach for Cryoablation of Atrial Fibrillation. J Atr Fibrillation. 2017 Aug 31;10(2):1628. doi: 10.4022/jafib.1628. eCollection 2017 Aug-Sep.
PubMed 29250235Hang F, Cheng L, Liang Z, Dong R, Wang X, Wang Z, Wang Z, Wu Y. Study on the Curative Effect and Safety of Radiofrequency Catheter Ablation of Paroxysmal Atrial Fibrillation via Zero-Fluoroscopy Transseptal Puncture under the Dual Guidance of Electroanatomical Mapping and Intracardiac Echocardiography. Cardiol Res Pract. 2021 May 24;2021:5561574. doi: 10.1155/2021/5561574. eCollection 2021.
PubMed 34123417Fromentin S, Sarrazin JF, Champagne J, Nault I, Philippon F, Molin F, Blier L, O'Hara G. Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energy. J Interv Card Electrophysiol. 2011 Sep;31(3):237-42. doi: 10.1007/s10840-011-9564-2. Epub 2011 Apr 19.
PubMed 21503731Knecht S, Jais P, Nault I, Wright M, Matsuo S, Madaffari A, Lellouche N, O'Neill MD, Derval N, Deplagne A, Bordachar P, Sacher F, Hocini M, Clementy J, Haissaguerre M. Radiofrequency puncture of the fossa ovalis for resistant transseptal access. Circ Arrhythm Electrophysiol. 2008 Aug;1(3):169-74. doi: 10.1161/CIRCEP.108.788000. Epub 2008 Jun 23.
PubMed 19808411Sawhney V, Breitenstein A, Watts T, Garcia J, Finlay M, Lowe M, Hunter R, Earley MJ, Schilling RJ, Sporton S, Dhinoja M. A novel technique for performing transseptal puncture guided by a non-fluoroscopic 3D mapping system. Pacing Clin Electrophysiol. 2019 Jan;42(1):4-12. doi: 10.1111/pace.13541. Epub 2018 Nov 28.
PubMed 30397922Koektuerk B, Yorgun H, Koektuerk O, Turan CH, Gorr E, Horlitz M, Turan RG. Rotational Angiography Based Three-Dimensional Left Atrial Reconstruction: A New Approach for Transseptal Puncture. Cardiovasc Ther. 2016 Feb;34(1):49-56. doi: 10.1111/1755-5922.12167.
PubMed 26607305Manolis AS. Transseptal Access to the Left Atrium: Tips and Tricks to Keep it Safe Derived from Single Operator Experience and Review of the Literature. Curr Cardiol Rev. 2017;13(4):305-318. doi: 10.2174/1573403X13666170927122036.
PubMed 28969539Rodriguez-Manero M, Martinez-Sande JL, Fandino R, Garcia-Seara J, Chierchia GB, Fernandez-Lopez XA, Osorio I, de Alegria AM, Souto-Bayarri M, Brugada P, Gonzalez-Juanatey JR. Fluoroscopic integration of the cardiac computed tomography as a guide for transseptal puncture during atrial fibrillation ablation: A feasibility study. Int J Cardiol. 2015 Apr 1;184:274-275. doi: 10.1016/j.ijcard.2015.02.035. Epub 2015 Feb 24. No abstract available.
PubMed 25731834Li C, Zhang J, Li S, Sang C, Liu N, Du X, Dong J, Ma C. A novel and easy approach to difficult transseptal puncture during atrial fibrillation ablation. J Interv Card Electrophysiol. 2021 Nov;62(2):269-276. doi: 10.1007/s10840-020-00891-y. Epub 2020 Oct 9.
PubMed 33034794ROSS J Jr, BRAUNWALD E, MORROW AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959 May;3(5):653-5. doi: 10.1016/0002-9149(59)90347-9. No abstract available.
PubMed 13649591Vlastra W, Delewi R, Sjauw KD, Beijk MA, Claessen BE, Streekstra GJ, Bekker RJ, van Hattum JC, Wykrzykowska JJ, Vis MM, Koch KT, de Winter RJ, Piek JJ, Henriques JPS. Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. Circ Cardiovasc Interv. 2017 Nov;10(11):e006058. doi: 10.1161/CIRCINTERVENTIONS.117.006058.
PubMed 29089313Salghetti F, Sieira J, Chierchia GB, Curnis A, de Asmundis C. Recognizing and reacting to complications of trans-septal puncture. Expert Rev Cardiovasc Ther. 2017 Dec;15(12):905-912. doi: 10.1080/14779072.2017.1408411. Epub 2017 Nov 30.
PubMed 29161923
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of a Three Dimensional Navigation Intracardiac Guidance Kit for Atrial Septal Puncture
- ClinicalTrials.gov ID
- NCT06188351
- Acronym / sponsor ID
- 3DASP study
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial septal puncture, Three dimensional, fluroscopy, Catheter Ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Wuhan Greenrhythm Medical Technology Co., LTD
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 3 Jan 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.
This study aims to evaluate the safety and efficacy of a three-dimensional navigation intracardiac guidance kit to perform atrial septal puncture in patients requiring catheter ablation, which will be compared with procedures using traditional kit for atrial septal puncture.
Detailed description
Atrial septal puncture has become a key technique in cardiac interventional procedures. Traditional septal punctures are routinely perfomed under two-dimensioanl guidance, whic are likely to be not acurate sometimes.
This study is aimed to study the safety and efficacy of a novel designed three-dimensional navigation Intracardiac guidance kit for atrial septal puncture in patients with atrial fibrillation requiring catheter ablation and to explore the possibility of transseptal without fluoroscopy using the three-dimensional positioning intracardiac guidance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three-Dimensional Navigation Atrial Septal Puncture | Experimental | Device: Three-Dimensional Navigation Atrial Septal PunctureAtrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit |
| Conventional Atrial Septal Puncture | Active comparator | Device: Conventional Atrial Septal PunctureAtrial septal puncture will be performed using trational atrial septal puncture kit using traditional method. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with atrial fibrillation.
- Requiring catheter ablation therapy.
- Voluntarily sign the informed consent.
Key exclusion criteria (14 listed)
- Previous atrial septal puncture.
- Blood clots in the left atrium or left atrial appendage
- Left atrial mucinous tumor.
- Atrial septal defect, including previous surgical correction or interventional occlusion.
- Acute or severe systemic infection.
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 |
|---|---|---|
| Three-Dimensional Navigation Atrial Septal PunctureAtrial septal puncture will be performed using a three-dimensional navigation intracardiac guidance kit | Device | Three-Dimensional Navigation Atrial Septal Puncture |
| Conventional Atrial Septal PunctureAtrial septal puncture will be performed using traditioanl two-dimensional atrial septal puncture kit using traditional method. | Device | Conventional Atrial Septal Puncture |
Primary outcome
Success rate of atrial septal puncture
Time frame: one day
Successful atrial septal puncture is defined as the right and left interatrial pathways are established and the ablation catheter can enter the left atrium smoothly for subsequent ablation operations.
X-Ray exposure time
Time frame: one day
X-ray exposure time from the successful femoral vein puncture to the entry of the external sheath into the left atrium (ending with heparin saline flushing of the sheath).
4 secondary outcomes
First puncture success rate of atrial septum
Time frame: one day
Atrial septal puncture duration
Time frame: one day
Total operation time
Time frame: one day
Performance evaluation of a three-dimensional positioning intracardiac guidance kit
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 32438994Yu R, Liu N, Lu J, Zhao X, Hu Y, Zhang J, Xu F, Tang R, Bai R, Akar JG, Dong J, Ma C. 3-Dimensional Transseptal Puncture Based on Electrographic Characteristics of Fossa Ovalis: A Fluoroscopy-Free and Echocardiography-Free Method. JACC Cardiovasc Interv. 2020 May 25;13(10):1223-1232. doi: 10.1016/j.jcin.2020.03.015.
- Background: PubMed 29250235Graham AJ, Honarbakhsh S, O'Brien B, Schilling RJ. A Simplified Trans-Septal Puncture Technique using a Needle Free Approach for Cryoablation of Atrial Fibrillation. J Atr Fibrillation. 2017 Aug 31;10(2):1628. doi: 10.4022/jafib.1628. eCollection 2017 Aug-Sep.
- Background: PubMed 34123417Hang F, Cheng L, Liang Z, Dong R, Wang X, Wang Z, Wang Z, Wu Y. Study on the Curative Effect and Safety of Radiofrequency Catheter Ablation of Paroxysmal Atrial Fibrillation via Zero-Fluoroscopy Transseptal Puncture under the Dual Guidance of Electroanatomical Mapping and Intracardiac Echocardiography. Cardiol Res Pract. 2021 May 24;2021:5561574. doi: 10.1155/2021/5561574. eCollection 2021.
- Background: PubMed 21503731Fromentin S, Sarrazin JF, Champagne J, Nault I, Philippon F, Molin F, Blier L, O'Hara G. Prospective comparison between conventional transseptal puncture and transseptal needle puncture with radiofrequency energy. J Interv Card Electrophysiol. 2011 Sep;31(3):237-42. doi: 10.1007/s10840-011-9564-2. Epub 2011 Apr 19.
- Background: PubMed 19808411Knecht S, Jais P, Nault I, Wright M, Matsuo S, Madaffari A, Lellouche N, O'Neill MD, Derval N, Deplagne A, Bordachar P, Sacher F, Hocini M, Clementy J, Haissaguerre M. Radiofrequency puncture of the fossa ovalis for resistant transseptal access. Circ Arrhythm Electrophysiol. 2008 Aug;1(3):169-74. doi: 10.1161/CIRCEP.108.788000. Epub 2008 Jun 23.
- Background: PubMed 30397922Sawhney V, Breitenstein A, Watts T, Garcia J, Finlay M, Lowe M, Hunter R, Earley MJ, Schilling RJ, Sporton S, Dhinoja M. A novel technique for performing transseptal puncture guided by a non-fluoroscopic 3D mapping system. Pacing Clin Electrophysiol. 2019 Jan;42(1):4-12. doi: 10.1111/pace.13541. Epub 2018 Nov 28.
- Background: PubMed 26607305Koektuerk B, Yorgun H, Koektuerk O, Turan CH, Gorr E, Horlitz M, Turan RG. Rotational Angiography Based Three-Dimensional Left Atrial Reconstruction: A New Approach for Transseptal Puncture. Cardiovasc Ther. 2016 Feb;34(1):49-56. doi: 10.1111/1755-5922.12167.
- Background: PubMed 28969539Manolis AS. Transseptal Access to the Left Atrium: Tips and Tricks to Keep it Safe Derived from Single Operator Experience and Review of the Literature. Curr Cardiol Rev. 2017;13(4):305-318. doi: 10.2174/1573403X13666170927122036.
- Background: PubMed 25731834Rodriguez-Manero M, Martinez-Sande JL, Fandino R, Garcia-Seara J, Chierchia GB, Fernandez-Lopez XA, Osorio I, de Alegria AM, Souto-Bayarri M, Brugada P, Gonzalez-Juanatey JR. Fluoroscopic integration of the cardiac computed tomography as a guide for transseptal puncture during atrial fibrillation ablation: A feasibility study. Int J Cardiol. 2015 Apr 1;184:274-275. doi: 10.1016/j.ijcard.2015.02.035. Epub 2015 Feb 24. No abstract available.
- Background: PubMed 33034794Li C, Zhang J, Li S, Sang C, Liu N, Du X, Dong J, Ma C. A novel and easy approach to difficult transseptal puncture during atrial fibrillation ablation. J Interv Card Electrophysiol. 2021 Nov;62(2):269-276. doi: 10.1007/s10840-020-00891-y. Epub 2020 Oct 9.
- Background: PubMed 13649591ROSS J Jr, BRAUNWALD E, MORROW AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959 May;3(5):653-5. doi: 10.1016/0002-9149(59)90347-9. No abstract available.
- Background: PubMed 29089313Vlastra W, Delewi R, Sjauw KD, Beijk MA, Claessen BE, Streekstra GJ, Bekker RJ, van Hattum JC, Wykrzykowska JJ, Vis MM, Koch KT, de Winter RJ, Piek JJ, Henriques JPS. Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. Circ Cardiovasc Interv. 2017 Nov;10(11):e006058. doi: 10.1161/CIRCINTERVENTIONS.117.006058.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
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.
Yan Wang, PhD principal investigator
Tongji Hospital Wuhan, Hubei China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-Dimensional Navigation Atrial Septal Puncture and Conventional Atrial Septal Puncture in people with Atrial Fibrillation, run by Tongji Hospital 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, PhD (+86-13697326307, newswangyan@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of atrial septal puncture (time frame: one day). The study lists 2 primary outcomes in all. 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 NCT06188351, which also lists 13 linked publications.
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 3 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.