Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis

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 standards currently exist for clinical trials evaluating paravalvular leak (PVL) closure devices, particularly for circumferentially sutured surgical valves.

Purpose of the Study:

• To establish core principles, clinical endpoints, and endpoint definitions for clinical trials focused on paravalvular leak closure devices.
• To provide a framework for assessing the safety and effectiveness of PVL closure interventions.

Main Methods:

• Convened the PVL Academic Research Consortium to review existing evidence and formulate recommendations.
• Developed a 5-class grading scheme for PVL assessment, aligning with VARC principles.
• Defined core principles, data collection methods, and updated endpoint definitions for PVL closure trials.

Main Results:

• Recommendations for the assessment of disease severity in PVL.
• Standardized definitions for clinical endpoints relevant to PVL closure.
• A novel 5-class grading scheme for PVL evaluation was created.
• Identified and outlined unresolved issues within the field of PVL closure.

Conclusions:

• The PVL Academic Research Consortium provides essential recommendations for conducting clinical trials on PVL closure devices.
• Standardization of endpoints and assessment methods is crucial for evaluating the safety and effectiveness of PVL closure technologies.
• Further research is warranted to address outstanding questions and advance the field of paravalvular leak management.