ACURATE neo2™ Post Market Clinical Follow up Study

Status Active, not recruiting

Clinical Trial Summary

The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.

Clinical Trial Description

ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study. A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled. Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year. ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04655248
Study type	Observational
Source	Boston Scientific Corporation
Contact
Status	Active, not recruiting
Phase
Start date	December 16, 2020
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03186339` - Validation of the "TASQ" in Patients Undergoing SAVR or TF-TAVI
Recruiting	`NCT03549559` - Imaging Histone Deacetylase in the Heart	N/A
Terminated	`NCT02854319` - REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System	N/A
Recruiting	`NCT05601453` - The ReTAVI Prospective Observational Registry
Withdrawn	`NCT05481814` - CPX in Paradoxical Low Flow Aortic Stenosis
Completed	`NCT02241109` - Predicting Aortic Stenosis Progression by Measuring Serum Calcification Propensity	N/A
Completed	`NCT01700439` - Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve	N/A
Recruiting	`NCT04429035` - SLOW-Slower Progress of caLcificatiOn With Vitamin K2	N/A
Completed	`NCT04103931` - Impact of a Patient Decision Aid for Treatment of Aortic Stenosis	N/A
Completed	`NCT03950440` - Assessing the Incidence of Postoperative Delirium Following Aortic Valve Replacement
Active, not recruiting	`NCT02661451` - Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)	N/A
Completed	`NCT02758964` - Evaluation of Cerebral Thrombembolism After TAVR
Completed	`NCT02847546` - Evaluation of the BARD® True™ Flow Valvuloplasty Perfusion Catheter for Aortic Valve Dilatation	N/A
Completed	`NCT02792452` - Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis
Not yet recruiting	`NCT02541877` - Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve	Phase 3
Not yet recruiting	`NCT02536703` - Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population	Phase 3
Completed	`NCT02249000` - BIOVALVE - I / II Clincial Investigation	N/A
Not yet recruiting	`NCT02221921` - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI	N/A
Active, not recruiting	`NCT02080299` - Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation	Phase 2
Terminated	`NCT01939678` - Characterization and Role of Mutations in Sodium-phosphate Cotransporters in Patients With Calcific Aortic Valve Disease