Iatrogenic Atrial Septal Defect Gradient for Intraprocedural Success After M-teer (IASIS)

August 29, 2026 updated by: Konstantinos Tsioufis, Hippocration General Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11521
        • First Cardiology Department, Hippokration General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: M-TEER patients
high- or prohibitive-surgical-risk patients with severe mitral regurgitation
Procedure: M-TEER
Hemodynamic and echocardiographic assessment of M-TEER procedural success

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hippocration General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Estimated)

June 10, 2028

Study Completion (Estimated)

June 10, 2028

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

August 29, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 29, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22532/19-12-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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