Atrial Septal Defect (ASD)Phase 4PANNA-ASDNCT07054541
A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
A Phase 4 study testing Ultrasound-guided intervention with assistance of specialized instruments and fluoroscopy-guided intervention in people with Atrial Septal Defect (ASD), run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment. Traditional percutaneous closure procedures are performed under fluoroscopic guidance and require contrast agents. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atrial Septal Defect (ASD)
- What is being tested?
- Ultrasound-guided intervention with assistance of specialized instruments and fluoroscopy-guided intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 666 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2026to 31 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 2 years
- Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
- The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm
- Age ≥ 2 years
- Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
- The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm
- Contraindications to radiation exposure or refusal to undergo fluoroscopy-guided procedures
Who cannot join
- Pregnant women
- Contrast agent allergy
- Renal insufficiency
- Associated cardiac malformations requiring surgical intervention
- Right-to-left shunt ASD
- Ostium primum ASD and sinus venosus ASD
Show all 14Show fewer
- Any severe infection within one month before the procedure
- Intracardiac thrombus
- Cohort Eligibility Criteria：
- Associated cardiac malformations requiring surgical intervention
- Right-to-left shunt ASD
- Ostium primum ASD and sinus venosus ASD
- Any severe infection within one month before the procedure
- Intracardiac thrombus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100037
Fengwen Zhang, MM, 088396666, Zhangfengwen08@126.com
Fengwen Zhang, MM
About this study
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment. Traditional percutaneous closure procedures are performed under fluoroscopic guidance and require contrast agents. A retrospective analysis of over 20,000 adult patients with congenital heart disease revealed that even low-dose radiation exposure was significantly associated with an increased long-term risk of malignancy. Moreover, the use of contrast agents carries the risk of allergic reactions and kidney injury. Radiation and contrast agents not only pose iatrogenic harm to patients but also limit the use of interventional techniques in special populations, such as pregnant women, patients with contrast agent allergies, or those with renal insufficiency.
To achieve radiation-free and contrast-free interventional closure procedures, researchers have developed ultrasound-guided percutaneous interventional techniques, yielding satisfactory treatment outcomes. In some cases, these techniques have even enabled cardiovascular procedures to be performed on an outpatient basis, significantly reducing hospitalization time and costs.
This project proposes a large-sample, multicenter, prospective randomized controlled study to determine whether ultrasound-guided percutaneous intervention for ASD with the assistance of specialized instruments is non-inferior to traditional fluoroscopy-guided procedures, while also offering shorter hospital stays and lower medical expenses.In addition, patients with radiation contraindications or who refuse radiation therapy, and who are willing to undergo ultrasound-guided percutaneous atrial septal defect (ASD) closure with the assistance of dedicated devices, will be enrolled in a separate observational cohort (observational cohort study).
- Conditions
- Atrial Septal Defect (ASD)
- Being tested
- Ultrasound-guided intervention with assistance of specialized instruments, fluoroscopy-guided intervention
- Keywords
- Ultrasound-guided, Percutaneous Intervention, Atrial Septal Defect, Pannawire, PAN Procedure, ASD closure, non fluoroscopic
- Medical subject headings
- Heart Septal Defects, Atrial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided intervention with assistance of specialized instrumentsProcedure or surgery
After detailed evaluation, patients will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments
fluoroscopy-guided interventionProcedure or surgery
After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided intervention with assistance of specialized instruments group | Experimental | Patients randomized in this group will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments. Receives: Procedure: Ultrasound-guided intervention with assistance of specialized instruments |
| fluoroscopy-guided intervention group | Active comparator | Patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process Receives: Procedure: fluoroscopy-guided intervention |
| cohort | Other | Patients meet requirements but have contraindications to fluoroscopy, such as pregnancy, contrast allergy, malignancy, or thyroid dysfunction, are enrolled in the single-arm observational cohort to undergo echocardiography-guided ASD closure assistead by PannaWire Receives: Procedure: Ultrasound-guided intervention with assistance of specialized instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate
Procedural success is defined as completion of the ASD closure without conversion to another guidance method or surgical repair under cardiopulmonary bypass, and with a residual shunt no greater than 2 mm immediately after implantation. Evaluation of the primary endpoint was done by specialized sonographers blinded to the intervention.
Measured: Immediately after implantation
Secondary outcomes (6)
Successful closure rate
Residual shunt ≤ 2 mm immediately after implantation, at 30 days, at 3 months after implantation
Measured: Immediately after implantation, at 30 days, at 3 months after implantation
Composite of major adverse events
Composite of major adverse events at 3 months, including sudden cardiac death, occluder displacement or dislodgement, pulmonary artery stenosis, descending aortic stenosis, pseudoaneurysm, bleeding requiring blood transfusion, new-onset hypertension, arrhythmia requiring pacemaker implantation or long-term medication, cardiac tamponade, stroke with sequelae.
Measured: At 3 months after implantation
Composite of minor adverse events
Composite of minor adverse events at 3 months, including groin hematoma, transient arrhythmia requiring medication or electrical cardioversion, perioperative allergic reaction, transient ischemic attack (TIA), anemia, postoperative infection.
Measured: At 3 months after implantation
Procedure time
Procedure time is defined as the duration from puncture to withdrawal of the arterial sheath
Measured: At discharge (assessed up to 3 months)
Days of hospital stay
Days of hospital stay
Measured: At discharge (assessed up to 3 months)
Hospitalization cost
cost during hospitalization
Measured: At discharge (assessed up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start14 Mar 2026 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Septal Defect (ASD)Studies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 666 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Fengwen Zhang, MM, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054541
- Sponsor's protocol ID
- 2025-2614
- Acronym
- PANNA-ASD
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire
- ClinicalTrials.gov ID
- NCT07054541
- Acronym / sponsor ID
- PANNA-ASD / 2025-2614
- Conditions
- Atrial Septal Defect (ASD)
- Keywords
- Ultrasound-guided, Percutaneous Intervention, Atrial Septal Defect, Pannawire, PAN Procedure, ASD closure, non fluoroscopic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 666 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 14 Mar 2026 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 8 Jul 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.
Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment. Traditional percutaneous closure procedures are performed under fluoroscopic guidance and require contrast agents. A retrospective analysis of over 20,000 adult patients with congenital heart disease revealed that even low-dose radiation exposure was significantly associated with an increased long-term risk of malignancy. Moreover, the use of contrast agents carries the risk of allergic reactions and kidney injury. Radiation and contrast agents not only pose iatrogenic harm to patients but also limit the use of interventional techniques in special populations, such as pregnant women, patients with contrast agent allergies, or those with renal insufficiency.
To achieve radiation-free and contrast-free interventional closure procedures, researchers have developed ultrasound-guided percutaneous interventional techniques, yielding satisfactory treatment outcomes. In some cases, these techniques have even enabled cardiovascular procedures to be performed on an outpatient basis, significantly reducing hospitalization time and costs.
This project proposes a large-sample, multicenter, prospective randomized controlled study to determine whether ultrasound-guided percutaneous intervention for ASD with the assistance of specialized instruments is non-inferior to traditional fluoroscopy-guided procedures, while also offering shorter hospital stays and lower medical expenses.In addition, patients with radiation contraindications or who refuse radiation therapy, and who are willing to undergo ultrasound-guided percutaneous atrial septal defect (ASD) closure with the assistance of dedicated devices, will be enrolled in a separate observational cohort (observational cohort study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided intervention with assistance of specialized instruments group | Experimental | Procedure: Ultrasound-guided intervention with assistance of specialized instrumentsPatients randomized in this group will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments. |
| fluoroscopy-guided intervention group | Active comparator | Procedure: fluoroscopy-guided interventionPatients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process |
| cohort | Other | Procedure: Ultrasound-guided intervention with assistance of specialized instrumentsPatients meet requirements but have contraindications to fluoroscopy, such as pregnancy, contrast allergy, malignancy, or thyroid dysfunction, are enrolled in the single-arm observational cohort to undergo echocardiography-guided ASD closure assistead by PannaWire |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 2 years
- Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
- The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm
- Age ≥ 2 years
- Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
Key exclusion criteria (14 listed)
- Pregnant women
- Contrast agent allergy
- Renal insufficiency
- Associated cardiac malformations requiring surgical intervention
- Right-to-left shunt ASD
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 |
|---|---|---|
| Ultrasound-guided intervention with assistance of specialized instrumentsAfter detailed evaluation, patients will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments | Procedure or surgery | Ultrasound-guided intervention with assistance of specialized instruments group, cohort |
| fluoroscopy-guided interventionAfter detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process | Procedure or surgery | fluoroscopy-guided intervention group |
Primary outcome
Procedural success rate
Time frame: Immediately after implantation
Procedural success is defined as completion of the ASD closure without conversion to another guidance method or surgical repair under cardiopulmonary bypass, and with a residual shunt no greater than 2 mm immediately after implantation. Evaluation of the primary endpoint was done by specialized sonographers blinded to the intervention.
6 secondary outcomes
Successful closure rate
Time frame: Immediately after implantation, at 30 days, at 3 months after implantation
Composite of major adverse events
Time frame: At 3 months after implantation
Composite of minor adverse events
Time frame: At 3 months after implantation
Procedure time
Time frame: At discharge (assessed up to 3 months)
Days of hospital stay
Time frame: At discharge (assessed up to 3 months)
Hospitalization cost
Time frame: At discharge (assessed up to 3 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Atrial Septal Defect (ASD)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
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Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
Atrial Septal Defect
Enrolling by invitation
Utility of the Perclose ProGlide™ Suture-Mediated Closure Device After Cardiologic Procedures Via the Femoral Vein Approach (Eight-Clover)
Atrial Fibrillation, Atrial Septal Defect
Not yet recruiting
Dapagliflozin and Right Heart Recovery After ASD Device Closure
ASD2(Secundum Atrial Septal Defect)
RecruitingObservational study
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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.
Fengwen Zhang, MM principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound-guided intervention with assistance of specialized instruments and fluoroscopy-guided intervention in people with Atrial Septal Defect (ASD), run by Chinese Academy of Medical Sciences, Fuwai 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 7 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: opening soon, as of the sponsor's last update on 17 Mar 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengwen Zhang, MM (+8688396666, Zhangfengwen08@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success rate (time frame: Immediately after implantation). 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 17 Mar 2026.