Paradigm
Research type
Research Study
Full title
PARAvalvular leak closure with the Amplatzer Valvular Plug occluDer for Interventional transcatheter closure for PVL with surgical bioloGical and Mechanical heart valve
IRAS ID
282486
Contact name
David Hildick-Smith
Contact email
Sponsor organisation
Abbott
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
The rationale for conducting the PARADIGM study is to evaluate the safety and effectiveness of the AVP III for closure of PVLs. Until recently, current treatment in the US and OUS included off-label use of various occluder devices. The study will collect safety and effectiveness data to support FDA approval and post market clinical follow-up (PMCF) requirements in Europe as a condition for CE Mark approval.
The principal investigator or authorised designee, will screen the patient against the inclusion and exclusion criteria. The PI or designee will discuss the study with those patients that meet the eligibility criteria and follow the informed consent procedure detailed in ISO 14155.
Standard-of-care data will be collected, and QoL-questionnaires will be administered at the baseline-visit and follow-up visits.
Participants will receive their device as per standard-of-care. Data will be collected on the procedure and at discharge. Participants will be in the study for 12 months years. Participants will be followed-up in clinic as standard-of-care at 30 days, 6 and 12 month time points.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0254
Date of REC Opinion
22 Oct 2020
REC opinion
Further Information Favourable Opinion