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Active Not Recruiting
NCT07798037
Iatrogenic Atrial Septal Defect Gradient for Intraprocedural Success After M-teer
Conditions: Iatrogenic ASD, Mitral Regurgitation
Sex: All
Ages: 40 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Hippocration General Hospital
Location: First Cardiology Department, Hippokration General Hospital Athens
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. 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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07798037). StuddyBuddy aggregates publicly available trial information.