Patent Oval ForamenNCT06793969
Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)
A study testing Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage and Conventional technique to pass the PFO tunnel in people with Patent Oval Foramen, run by RenJi Hospital at 1 site in China.
Trial summary
The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter. In this study, we aim to investigate the efficacy and safety of Swartz sheath with angioplasty guidewire-assisted technique for PFO Closure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patent Oval Foramen
- What is being tested?
- Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage and Conventional technique to pass the PFO tunnel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2023to 30 May 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 65
- Confirmed diagnosis of PFO by transthoracic and transesophageal echocardiography
- A history of cryptogenic stroke (CS) or transient ischemic attack (TIA)
Who cannot join
- Confirmed pregnancy
- Confirmed diagnosis of intracardiac thrombosis
- Confirmed diagnosis of pulmonary hypertension
- Confirmed diagnosis of rheumatic heart disease, or valvular heart disease
- Past medical history of myocardial infarction, unstable angina and intracranial hemorrhage
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
Renji Hospital
Shanghai, 200127
ZHIGUO ZOU, MD, PhD, +86 13524596108, zouzhiguo@renji.com
About this study
Official title: Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial
The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter. In this study, we aim to investigate the efficacy and safety of Swartz sheath with angioplasty guidewire-assisted technique for PFO Closure.
Read the detailed description
In cases of complex PFO, failure of guidewire passage through the septum can occur, rendering closure impossible. The present multicenter, prospective, randomized controlled trial aims to evaluate the efficacy and safety of a novel Swartz sheath with angioplasty guidewire-assisted technique to facilitate PFO tunnel passage.
With written consent, the investigators expect to enrol PFO patients with a history of cryptogenic stroke (CS) or transient ischemic attack (TIA), who requires PFO closure according to current guidelines. A standardized TEE protocol is used to assess the morphologic characteristics of the atrial septum and right-to-left shunting through PFO. Eligible patients are prospectively and randomly assigned to the Swartz sheath + angioplasty guidewire group or the conventional group (1:1 ratio). In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance. In the conventional group, the PFO closure procedure is performed with a multi-functional catheter. After the procedure, safety parameters such as contrast use, procedure time, and severe complications are recorded. All patients are followed up at 1-, 3-, 6-, and 12- month post device implantation. The presence of a residual shunt, device embolization, device migration and residual shunt are recorded.
- Conditions
- Patent Oval Foramen
- Being tested
- Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage, Conventional technique to pass the PFO tunnel
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passageProcedure or surgery
The angioplasty guidewire is advanced into the left atrium and left superior pulmonary vein (LSPV). The Swartz sheath is then delivered to the left atrium along the 0.014" guidewire through the PFO. Next, the Runthrough guidewire is changed to a 0.035" J-tipped guidewire, which is advanced into the LSPV. Finally, the delivery sheath for the PFO closure device is introduced to the left atrium along the guidewire, and all other toolkits are withdrawn.
Conventional technique to pass the PFO tunnelProcedure or surgery
In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and ICE
| Study group | Role | What they receive |
|---|---|---|
| The conventional group | Sham comparator | In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and intracardiac echocardiography (ICE). Receives: Procedure: Conventional technique to pass the PFO tunnel |
| The Swartz sheath + angioplasty guidewire group | Active comparator | In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance and guided by intraprocedural fluoroscopy and ICE. Receives: Procedure: Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of PFO tunnel passage
The total time required to pass the guide across PFO tunnel
Measured: Intraprocedural assessment (measured in minutes )
Secondary outcomes (4)
Procedure Time
The total time required to complete PFO closcure
Measured: Intraprocedural assessment (measured in minutes )
Fluoroscopy Time
The total fluoroscopy time during the procedure
Measured: Intraprocedural assessment (measured in minutes )
Procedural Complications
Complications such as inguinal haematoma and pericardial effusion related to the PFO closure procedure
Measured: Intraprocedural assessment
Radiation Dose
The total dosage of radiation required to complete the PFO closure procedure
Measured: Intraprocedural assessment (measured in mGys)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start24 Dec 2023
- Primary completion30 Mar 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Oval ForamenStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793969
- Sponsor's protocol ID
- STAGE-PFO
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06793969
- Acronym / sponsor ID
- STAGE-PFO
- Conditions
- Patent Oval Foramen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 24 Dec 2023 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 27 Jan 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.
The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter. In this study, we aim to investigate the efficacy and safety of Swartz sheath with angioplasty guidewire-assisted technique for PFO Closure.
Detailed description
In cases of complex PFO, failure of guidewire passage through the septum can occur, rendering closure impossible. The present multicenter, prospective, randomized controlled trial aims to evaluate the efficacy and safety of a novel Swartz sheath with angioplasty guidewire-assisted technique to facilitate PFO tunnel passage.
With written consent, the investigators expect to enrol PFO patients with a history of cryptogenic stroke (CS) or transient ischemic attack (TIA), who requires PFO closure according to current guidelines. A standardized TEE protocol is used to assess the morphologic characteristics of the atrial septum and right-to-left shunting through PFO. Eligible patients are prospectively and randomly assigned to the Swartz sheath + angioplasty guidewire group or the conventional group (1:1 ratio). In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance. In the conventional group, the PFO closure procedure is performed with a multi-functional catheter. After the procedure, safety parameters such as contrast use, procedure time, and severe complications are recorded. All patients are followed up at 1-, 3-, 6-, and 12- month post device implantation. The presence of a residual shunt, device embolization, device migration and residual shunt are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The conventional group | Sham comparator | Procedure: Conventional technique to pass the PFO tunnelIn the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and intracardiac echocardiography (ICE). |
| The Swartz sheath + angioplasty guidewire group | Active comparator | Procedure: Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passageIn the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance and guided by intraprocedural fluoroscopy and ICE. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 65
- Confirmed diagnosis of PFO by transthoracic and transesophageal echocardiography
- A history of cryptogenic stroke (CS) or transient ischemic attack (TIA)
Key exclusion criteria (5 listed)
- Confirmed pregnancy
- Confirmed diagnosis of intracardiac thrombosis
- Confirmed diagnosis of pulmonary hypertension
- Confirmed diagnosis of rheumatic heart disease, or valvular heart disease
- Past medical history of myocardial infarction, unstable angina and intracranial hemorrhage
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 |
|---|---|---|
| Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passageThe angioplasty guidewire is advanced into the left atrium and left superior pulmonary vein (LSPV). The Swartz sheath is then delivered to the left atrium along the 0.014" guidewire through the PFO. Next, the Runthrough guidewire is changed to a 0.035" J-tipped guidewire, which is advanced into the LSPV. Finally, the delivery sheath for the PFO closure device is introduced to the left atrium along the guidewire, and all other toolkits are withdrawn. | Procedure or surgery | The Swartz sheath + angioplasty guidewire group |
| Conventional technique to pass the PFO tunnelIn the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and ICE | Procedure or surgery | The conventional group |
Primary outcome
Time of PFO tunnel passage
Time frame: Intraprocedural assessment (measured in minutes )
The total time required to pass the guide across PFO tunnel
4 secondary outcomes
Procedure Time
Time frame: Intraprocedural assessment (measured in minutes )
Fluoroscopy Time
Time frame: Intraprocedural assessment (measured in minutes )
Procedural Complications
Time frame: Intraprocedural assessment
Radiation Dose
Time frame: Intraprocedural assessment (measured in mGys)
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 27 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage and Conventional technique to pass the PFO tunnel in people with Patent Oval Foramen, run by RenJi 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 5 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 27 Jan 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. Some participants in this study may receive a placebo. 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 ZHIGUO ZOU, MD, PhD (+86 13524596108, zouzhiguo@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of PFO tunnel passage (time frame: Intraprocedural assessment (measured in minutes )). 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 27 Jan 2025.