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Photo for REdireCT TAVI

REdireCT TAVI

Official Title

Remote ECG Monitoring to Reduce Complications following Transcatheter Aortic Valve Implantations

Status

Ongoing

Overview

REdireCT TAVI is a feasibility study of patients booked for an outpatient transcatheter Aortic Valve Implantation (TAVI) procedure to assess implementation of remote loop monitoring as part of a strategy of standardized electrophysiology assessment pre- and post-TAVI. Patients will have continuous home monitoring using m-Health solutions m-CARDSTM system both pre- and post-TAVI procedure, in order to detect intermittent conduction abnormalities, such as heart block and atrial fibrillation. The primary objective of this study is to assess feasibility and patient and clinical team experience and to gather information useful for implementing a larger study for clinical outcomes including length of stay post-TAVR, arrhythmia related re-hospitalizations and cost-effectiveness.

Study Design

Interventional Device Feasibility Study

Primary Endpoint

Feasibility of enrollment; patient adherence to loop monitoring pre and post TAVI; pre-TAVI identification of cohort requiring permanent pacemaker; medical assessment within 24 hours of identified “serious” arrhythmia pre- or post-TAVI; positive rating on patient and clinical team experience surveys.

Number of Patients

240

Number of Sites

3

Number of Countries

1

Study Period

2018-2020

Principal Investigator

Dr. Madhu K. Natarajan (PI), Dr. Jeff Healey, Dr. Tej Sheth, Dr. Jon-David Schwalm, Dr. James Velianou, Dr. Warren Cantor, Dr. Harindra Wijeysundara

Program Manager

Heather Beresh

Research Coordinator

Toni Newman

Collaborators

M-Health Solutions