Pulmonary Arterial HypertensionFREEFLOWNCT06605794
FreeFlow Percutaneous Atrial Septal Shunt for IPAH
A study testing FreeFlow percutaneous atrial septal shunt in people with Pulmonary Arterial Hypertension, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to explore the safety and efficacy of the FreeFlow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- FreeFlow percutaneous atrial septal shunt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2023to 11 Sep 2027
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18≤ age ≤70 years old, female or male;
- 10 mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg;
- The subjects had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure > 45 mmHg);
- WHO grade III or IV;
- NT-proBNP≥650 ng/L;
- The subjects were informed of the nature of the study and agreed to all the requirements for participating in the study. They signed the informed consent form and agreed to complete the follow-up and the examinations required for the follow-up.
Who cannot join
- Local or systemic sepsis or other acute infection;
- Severe coagulopathy;
- Allergy to nickel and/or titanium and/or nickel/titanium-based materials;
- Patients with contraindications to antiplatelet, coagulant or thrombotic therapy;
- Intolerance to contrast media;
- Have participated in other drug or device clinical trials during the same period;
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- Glomerular filtration rate (GFR) < 50 mL/min;
- Patients with severe liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal);
- The patient had malignant arrhythmia;
- The patient did not receive standardized drug therapy (triple sequential therapy) according to the Chinese guidelines for the diagnosis and treatment of pulmonary hypertension within 3 months;
- Women who are pregnant, planning to become pregnant (within 12 months) or breastfeeding;
- Severe restrictive or obstructive lung disease;
- Implanted atrial septal defect (ASD)/ patent foramen ovale (PFO) closure device;
- Left ventricular ejection fraction (LVEF) <50%;
- SpO2 < 90% without oxygen inhalation (pulse measurement);
- The anatomical structure of the heart is abnormal, and the shunt cannot be implanted on the atrial septum;
- Other circumstances in which the patient was deemed by the investigator to be ineligible for inclusion in the trial.
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, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Dandan CHEN, Dr, +8613788926105, chen.dandan@zs-hospital.sh.cn
Daxin ZHOU, Dr, +8613801641252, zhou.daxin@zs-hospital.sh.cn
About this study
Official title: A Prospective, Multi-center Study to Evaluate the Safety and Efficacy of FreeFlow Percutaneous Atrial Septal Shunt in Patients With Idiopathic Pulmonary Arterial Hypertension
The goal of this clinical trial is to explore the safety and efficacy of the FreeFlow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. The main questions it aims to answer are:
- Is the FreeFlow percutaneous atrial septal shunt safe to use in patients with idiopathic pulmonary arterial hypertension?
- Does the FreeFlow percutaneous atrial septal shunt reduce all-cause mortality and readmission in patients with idiopathic pulmonary arterial hypertension, and how effective is it? Thirty subjects who met the inclusion and exclusion criteria were selected for selective implantation of FreeFlow percutaneous atrial septal shunts after balloon atrial septostomy.
Read more
Participants will:
- underwent balloon atrial septostomy and FreeFlow percutaneous atrial septal shunt implantation.
- will be followed up at 24 hours after shunt implantation or before discharge, 1 month, 3 months, 6 months and 12 months.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- FreeFlow percutaneous atrial septal shunt
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeFlow percutaneous atrial septal shuntDevice
The trial devices included a percutaneous atrial septal shunt and an atrial septal shunt delivery system. The specifications of the atrial septal shunt device were -φ5, φ7, φ9, φ11, and the specifications of the atrial septal shunt delivery system-FFISS-B were 9F and 10F.
| Study group | Role | What they receive |
|---|---|---|
| Device-intervention Group | Experimental | FreeFlow percutaneous atrial septal shunt Receives: Device: FreeFlow percutaneous atrial septal shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at 6 months
All-cause mortality at 6 months
Measured: 6 months
Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension
Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension within 6 months
Measured: 6 months
Secondary outcomes (9)
Effective shunt rate at the end point
Effective shunt was defined as the presence of intra-atrial shunt by echocardiography at 12 months after operation, and the diameter of the shunt was reduced by no more than 2mm compared with the diameter measured by echocardiography before discharge
Measured: 12 months
Shunt Success rate
Successful shunt operation was defined as successful shunt implantation, normal morphology and position, and basically the expected shunt size under fluoroscopy.
Measured: 12 months
The WHO functional class was changed 12 months after operation
The WHO functional class was changed 12 months after operation
Measured: 12 months
Changes in NT-pro BNP at 12 months after surgery
Changes in NT-pro BNP at 12 months after surgery
Measured: 12 months
The change of exercise capacity (6min walking test) was observed 12 months after operation
The change of exercise capacity (6min walking test) was observed 12 months after operation
Measured: 12 months
The change of subjects' Kansas City Cardiomyopathy Quality of Life Questionnaire score at 12 months after surgery
The change of subjects' Kansas City Cardiomyopathy Quality of Life Questionnaire score at 12 months after surgery
Measured: 12 months
Cumulative number of readmissions associated with exacerbation of pulmonary hypertension at 12 months after surgery
Cumulative number of readmissions associated with exacerbation of pulmonary hypertension at 12 months after surgery
Measured: 12 months
Serious Adverse Event Rate (SAE)
Serious adverse event rate (SAE) refers to events occurring during the course of the clinical trial that lead to death or serious deterioration of health status, including fatal illness or injury, permanent defects in body structure or function, and the need for medical or surgical intervention to avoid permanent defects in body structure or function.
Measured: through study completion, an average of 1 year
Device-related Adverse Event Rate (DSAE)
The device-related adverse event rate (DSAE) refers to the adverse medical events related to the use of the device that occurred during the course of the clinical trial.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start11 Sep 2023
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junbo GE, Prof., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605794
- Sponsor's protocol ID
- 2023-111R
- Acronym
- FREEFLOW
- Status last verified
- Sep 2024
- First submitted
- 20 Aug 2024
- Last updated
- 20 Sep 2024
- 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 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Study to Evaluate the Safety and Efficacy of FreeFlow Percutaneous Atrial Septal Shunt in Patients With Idiopathic Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06605794
- Acronym / sponsor ID
- FREEFLOW / 2023-111R
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 20 Sep 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.
The goal of this clinical trial is to explore the safety and efficacy of the FreeFlow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. The main questions it aims to answer are:
- Is the FreeFlow percutaneous atrial septal shunt safe to use in patients with idiopathic pulmonary arterial hypertension?
- Does the FreeFlow percutaneous atrial septal shunt reduce all-cause mortality and readmission in patients with idiopathic pulmonary arterial hypertension, and how effective is it? Thirty subjects who met the inclusion and exclusion criteria were selected for selective implantation of FreeFlow percutaneous atrial septal shunts after balloon atrial septostomy.
Participants will:
- underwent balloon atrial septostomy and FreeFlow percutaneous atrial septal shunt implantation.
- will be followed up at 24 hours after shunt implantation or before discharge, 1 month, 3 months, 6 months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device-intervention Group | Experimental | Device: FreeFlow percutaneous atrial septal shuntFreeFlow percutaneous atrial septal shunt |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18≤ age ≤70 years old, female or male;
- 10 mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg;
- The subjects had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure > 45 mmHg);
- WHO grade III or IV;
- NT-proBNP≥650 ng/L;
Key exclusion criteria (17 listed)
- Local or systemic sepsis or other acute infection;
- Severe coagulopathy;
- Allergy to nickel and/or titanium and/or nickel/titanium-based materials;
- Patients with contraindications to antiplatelet, coagulant or thrombotic therapy;
- Intolerance to contrast media;
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 |
|---|---|---|
| FreeFlow percutaneous atrial septal shuntThe trial devices included a percutaneous atrial septal shunt and an atrial septal shunt delivery system. The specifications of the atrial septal shunt device were -φ5, φ7, φ9, φ11, and the specifications of the atrial septal shunt delivery system-FFISS-B were 9F and 10F. | Device | Device-intervention Group |
Primary outcome
All-cause mortality at 6 months
Time frame: 6 months
All-cause mortality at 6 months
Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension
Time frame: 6 months
Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension within 6 months
9 secondary outcomes
Effective shunt rate at the end point
Time frame: 12 months
Shunt Success rate
Time frame: 12 months
The WHO functional class was changed 12 months after operation
Time frame: 12 months
Changes in NT-pro BNP at 12 months after surgery
Time frame: 12 months
The change of exercise capacity (6min walking test) was observed 12 months after operation
Time frame: 12 months
The change of subjects' Kansas City Cardiomyopathy Quality of Life Questionnaire score at 12 months after surgery
Time frame: 12 months
Cumulative number of readmissions associated with exacerbation of pulmonary hypertension at 12 months after surgery
Time frame: 12 months
Serious Adverse Event Rate (SAE)
Time frame: through study completion, an average of 1 year
Device-related Adverse Event Rate (DSAE)
Time frame: through study completion, an average of 1 year
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 20 Sep 2024.
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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.
Junbo GE, Prof. principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeFlow percutaneous atrial septal shunt in people with Pulmonary Arterial Hypertension, run by Shanghai Zhongshan 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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 20 Sep 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?
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 Daxin ZHOU, Prof. (13801641252, zhou.daxin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at 6 months (time frame: 6 months). 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?
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 20 Sep 2024.