Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis: An Expert Statement

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Device Research

Background:

• The Valve Academic Research Consortium (VARC) standardized endpoints for transcatheter aortic valve replacement trials.
• No established standardization exists for clinical endpoints in trials of circumferentially sutured surgical valve paravalvular leak (PVL) closure devices.
• This lack of standardization hinders consistent evaluation of PVL closure device safety and effectiveness.

Purpose of the Study:

• To establish core principles, clinical endpoints, and endpoint definitions for clinical trials focused on PVL closure devices.
• To provide a framework for assessing disease severity and collecting data in PVL closure studies.
• To create a standardized approach for evaluating the efficacy and safety of PVL closure interventions.

Main Methods:

• Convening the PVL Academic Research Consortium to review existing evidence.
• Developing recommendations for the assessment of PVL disease severity.
• Establishing updated endpoint definitions and a 5-class grading scheme for PVL evaluation, aligned with VARC principles.

Main Results:

• A comprehensive set of core principles and recommendations for PVL closure trials has been developed.
• A 5-class grading scheme for PVL assessment was created, harmonizing with VARC standards.
• Key areas requiring further research and unresolved issues in PVL closure were identified.

Conclusions:

• The PVL Academic Research Consortium provides crucial recommendations for standardizing PVL closure device trials.
• Standardized endpoints and assessment methods are essential for reliable evaluation of PVL closure technologies.
• Further research is necessary to address remaining challenges and advance the field of PVL closure.