Iatrogenic ASDIASISNCT07798037
Iatrogenic Atrial Septal Defect Gradient for Intraprocedural Success After M-teer
A study testing M-TEER in people with Iatrogenic ASD and Mitral Regurgitation, run by Hippocration General Hospital at 1 site in Greece.
Trial summary
Transcatheter mitral edge-to-edge repair (M-TEER) has become an established minimally invasive therapy for patients with severe mitral regurgitation (MR) who are at high or prohibitive surgical risk. However, accurate quantification of residual MR after M-TEER remains challenging. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Iatrogenic ASD, Mitral Regurgitation
- What is being tested?
- M-TEER
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 9 Sep 2024to 10 Jun 2028
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with high or prohibitive surgical risk and moderate-to-severe or severe symptomatic MR, despite the administration of maximally tolerated doses of guideline-directed medical therapy and, if appropriate, cardiac resynchronization therapy
- patients undergoing M-TEER as a bridge to heart transplantation
Who cannot join
- Patients with post-procedural transmitral gradient ≥5 mmHg,
- Patients with right-to-left shunt requiring iASD closure,
- Patients, who decline to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
Greece1 site
First Cardiology Department, Hippokration General Hospital
Athens, 11521
About this study
Official title: Iatrogenic ASD Gradient as a Marker of Residual Mitral Regurgitation Severity After M-TEER Procedure
Transcatheter mitral edge-to-edge repair (M-TEER) has become an established minimally invasive therapy for patients with severe mitral regurgitation (MR) who are at high or prohibitive surgical risk. However, accurate quantification of residual MR after M-TEER remains challenging. In this direction, the hemodynamic significance of the post-procedural iatrogenic atrial septal defect (iASD) gradient is unknown. The objective of this study is to assess the relationship between the post-procedural iASD pressure gradient and the severity of residual MR with intraprocedural echocardiographic and hemodynamic parameters.
Read the detailed description
The present study plans to enroll patients with high or prohibitive surgical risk and moderate-to-severe or severe symptomatic MR, despite the administration of maximally tolerated doses of guideline-directed medical therapy and, if appropriate, cardiac resynchronization therapy. Patients with severe tricuspid regurgitation, post-procedural transmitral gradient >5 mmHg, right-to-left shunt requiring iASD closure, or refusal to provide written informed consent will be excluded. All intraoperative transesophageal echo loops will be acquired using an EPIQ ultrasound system (Philips, Eindhoven, Netherlands) with an X8-2t transesophageal probe. At the end of the procedure, in the mid-esophageal aortic valve short-axis view, flow across the iASD will be assessed immediately after catheter withdrawal from the left atrium using continuous-wave Doppler interrogation. Through a cardiac cycle, the mean pressure gradient between the left and right atria will be calculated while maintaining hemodynamic stability. Digitally stored image loops will be analyzed offline. Blinded analysis will be performed by an independent investigator. For assessment of residual MR, multiplanar reconstruction will be used, and the largest systolic 3D-VCA will be measured. When multiple regurgitant jets are present, the total regurgitant orifice area will be calculated as the sum of the individual 3D-VCAs. The primary endpoint is to determine the association and diagnostic performance of the post-procedural mean left-to-right iASD pressure gradient, measured immediately after catheter withdrawal, for identifying moderate-or-greater residual mitral regurgitation after M-TEER, as assessed by blinded offline 3D-VCA analysis.
- Conditions
- Iatrogenic ASD, Mitral Regurgitation
- Being tested
- M-TEER
- Keywords
- iatrogenic ASD, mitral regurgitation, M-TEER
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TEERProcedure or surgery
Hemodynamic and echocardiographic assessment of M-TEER procedural success
| Study group | Role | What they receive |
|---|---|---|
| M-TEER patients | Other | high- or prohibitive-surgical-risk patients with severe mitral regurgitation Receives: Procedure: M-TEER |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-procedural mean left-to-right iASD pressure gradient, measured immediately after catheter withdrawal, for identifying moderate-or-greater residual mitral regurgitation after M-TEER
Measured: The iASD gradient, echocardiographic and hemodynamic markers of procedural success will be assessed immediately after catheter withdrawal at the end of the M-TEER procedure.
the cut-off point of iASD gradient for identifying mild or trivial mitral regurgitation after M-TEER procedure
To determine the cut-off point of the post-procedural iASD gradient for identifying mild or trivial residual mitral regurgitation after M-TEER procedure
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start9 Sep 2024
- Primary completion10 Jun 2028 (estimated)
- Study completion10 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic ASDStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Tsioufis, Hippocration General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798037
- Sponsor's protocol ID
- 22532/19-12-2023
- Acronym
- IASIS
- Status last verified
- Aug 2026
- First submitted
- 11 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sakul S, DiazSaravia S, Berman B, Dominguez AC, Lerakis S, Argulian E. "Echo-derived estimate of peak left atrial pressure in patients with iatrogenic atrial septal defects following transcatheter mitral edge-to-edge repair". Int J Cardiol. 2026 Feb 1;444:133975. doi: 10.1016/j.ijcard.2025.133975. Epub 2025 Oct 25.
PubMed 41591311Zoghbi WA, Asch FM, Bruce C, Gillam LD, Grayburn PA, Hahn RT, Inglessis I, Islam AM, Lerakis S, Little SH, Siegel RJ, Skubas N, Slesnick TC, Stewart WJ, Thavendiranathan P, Weissman NJ, Yasukochi S, Zimmerman KG. Guidelines for the Evaluation of Valvular Regurgitation After Percutaneous Valve Repair or Replacement: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Japanese Society of Echocardiography, and Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2019 Apr;32(4):431-475. doi: 10.1016/j.echo.2019.01.003. Epub 2019 Feb 20. No abstract available.
PubMed 30797660Little SH, Quader N, Brady M, Dillenbeck A, Garcia-Sayan E, Jain R, Mackensen GB, Price MJ, Saric M, Scalia GM, Wang DD, Hahn RT. Guidelines for the Intraprocedural Imaging for Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER): Recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2026 Jun;39(6):529-550. doi: 10.1016/j.echo.2026.03.003.
PubMed 42242827
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iatrogenic ASD Gradient as a Marker of Residual Mitral Regurgitation Severity After M-TEER Procedure
- ClinicalTrials.gov ID
- NCT07798037
- Acronym / sponsor ID
- IASIS / 22532/19-12-2023
- Conditions
- Iatrogenic ASD, Mitral Regurgitation
- Keywords
- iatrogenic ASD, mitral regurgitation, M-TEER
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 10 Jun 2028 (estimated)
- Study completion
- 10 Jun 2028 (estimated)
- First posted
- 1 Sep 2026 (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.
Transcatheter mitral edge-to-edge repair (M-TEER) has become an established minimally invasive therapy for patients with severe mitral regurgitation (MR) who are at high or prohibitive surgical risk. However, accurate quantification of residual MR after M-TEER remains challenging. In this direction, the hemodynamic significance of the post-procedural iatrogenic atrial septal defect (iASD) gradient is unknown. The objective of this study is to assess the relationship between the post-procedural iASD pressure gradient and the severity of residual MR with intraprocedural echocardiographic and hemodynamic parameters.
Detailed description
The present study plans to enroll patients with high or prohibitive surgical risk and moderate-to-severe or severe symptomatic MR, despite the administration of maximally tolerated doses of guideline-directed medical therapy and, if appropriate, cardiac resynchronization therapy. Patients with severe tricuspid regurgitation, post-procedural transmitral gradient >5 mmHg, right-to-left shunt requiring iASD closure, or refusal to provide written informed consent will be excluded. All intraoperative transesophageal echo loops will be acquired using an EPIQ ultrasound system (Philips, Eindhoven, Netherlands) with an X8-2t transesophageal probe. At the end of the procedure, in the mid-esophageal aortic valve short-axis view, flow across the iASD will be assessed immediately after catheter withdrawal from the left atrium using continuous-wave Doppler interrogation. Through a cardiac cycle, the mean pressure gradient between the left and right atria will be calculated while maintaining hemodynamic stability. Digitally stored image loops will be analyzed offline. Blinded analysis will be performed by an independent investigator. For assessment of residual MR, multiplanar reconstruction will be used, and the largest systolic 3D-VCA will be measured. When multiple regurgitant jets are present, the total regurgitant orifice area will be calculated as the sum of the individual 3D-VCAs. The primary endpoint is to determine the association and diagnostic performance of the post-procedural mean left-to-right iASD pressure gradient, measured immediately after catheter withdrawal, for identifying moderate-or-greater residual mitral regurgitation after M-TEER, as assessed by blinded offline 3D-VCA analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M-TEER patients | Other | Procedure: M-TEERhigh- or prohibitive-surgical-risk patients with severe mitral regurgitation |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with high or prohibitive surgical risk and moderate-to-severe or severe symptomatic MR, despite the administration of maximally tolerated doses of guideline-directed medical therapy and, if appropriate, cardiac resynchronization therapy
- patients undergoing M-TEER as a bridge to heart transplantation
Key exclusion criteria (3 listed)
- Patients with post-procedural transmitral gradient ≥5 mmHg,
- Patients with right-to-left shunt requiring iASD closure,
- Patients, who decline to provide written informed consent.
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 |
|---|---|---|
| M-TEERHemodynamic and echocardiographic assessment of M-TEER procedural success | Procedure or surgery | M-TEER patients |
Primary outcome
post-procedural mean left-to-right iASD pressure gradient, measured immediately after catheter withdrawal, for identifying moderate-or-greater residual mitral regurgitation after M-TEER
Time frame: The iASD gradient, echocardiographic and hemodynamic markers of procedural success will be assessed immediately after catheter withdrawal at the end of the M-TEER procedure.
the cut-off point of iASD gradient for identifying mild or trivial mitral regurgitation after M-TEER procedure
Time frame: 4 years
To determine the cut-off point of the post-procedural iASD gradient for identifying mild or trivial residual mitral regurgitation after M-TEER procedure
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 1 Sep 2026.
- Background: PubMed 41591311Sakul S, DiazSaravia S, Berman B, Dominguez AC, Lerakis S, Argulian E. "Echo-derived estimate of peak left atrial pressure in patients with iatrogenic atrial septal defects following transcatheter mitral edge-to-edge repair". Int J Cardiol. 2026 Feb 1;444:133975. doi: 10.1016/j.ijcard.2025.133975. Epub 2025 Oct 25.
- Background: PubMed 30797660Zoghbi WA, Asch FM, Bruce C, Gillam LD, Grayburn PA, Hahn RT, Inglessis I, Islam AM, Lerakis S, Little SH, Siegel RJ, Skubas N, Slesnick TC, Stewart WJ, Thavendiranathan P, Weissman NJ, Yasukochi S, Zimmerman KG. Guidelines for the Evaluation of Valvular Regurgitation After Percutaneous Valve Repair or Replacement: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Angiography and Interventions, Japanese Society of Echocardiography, and Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2019 Apr;32(4):431-475. doi: 10.1016/j.echo.2019.01.003. Epub 2019 Feb 20. No abstract available.
- Background: PubMed 42242827Little SH, Quader N, Brady M, Dillenbeck A, Garcia-Sayan E, Jain R, Mackensen GB, Price MJ, Saric M, Scalia GM, Wang DD, Hahn RT. Guidelines for the Intraprocedural Imaging for Mitral Valve Transcatheter Edge-to-Edge Repair (M-TEER): Recommendations from the American Society of Echocardiography. J Am Soc Echocardiogr. 2026 Jun;39(6):529-550. doi: 10.1016/j.echo.2026.03.003.
- Individual participant dataSharing planned: Undecided
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 M-TEER in people with Iatrogenic ASD and Mitral Regurgitation, run by Hippocration General Hospital at 1 site in Greece.
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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 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 Greece. 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?
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?
post-procedural mean left-to-right iASD pressure gradient, measured immediately after catheter withdrawal, for identifying moderate-or-greater residual mitral regurgitation after M-TEER (time frame: The iASD gradient, echocardiographic and hemodynamic markers of procedural success will be assessed immediately after catheter withdrawal at the end of the M-TEER procedure.). 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 NCT07798037, which also lists 3 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 1 Sep 2026.