Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study

N/AActive Not RecruitingNCT04298593

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval200 enrolled

Overview

TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.

Prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the diagnosis of the arrhythmic event. Analyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

TAVI ECG Monitoring

Interventions

CardiostatDEVICE

This is a prospective observational study including patients accepted by the heart team for a TAVI procedure. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. Following the TAVI procedure, the patients will be under telemetry until hospital discharge and, at hospital discharge, they will be monitorized up to 4 more weeks using the CardioSTAT® device.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves. Exclusion Criteria: * Failure to provide informed consent. * Prior or post-procedural pacemaker * In-hospital death * Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure * Participation in another continuous ECG monitoring post-TAVI trial

Locations (1)

IUCPQ

Québec, Quebec, Canada

Outcomes

Primary Outcomes

Incidence of arrhythmic events

Incidence of arrhythmic events after discharge in TAVI recipients.

Time frame: within the first weeks after the procedure, an average of 4 weeks

Type of arrhythmic events

Type of arrhythmic events after discharge in TAVI recipients.

Time frame: within the first weeks after the procedure, an average of 4 weeks

Incidence of arrhythmic events and treatment modification

Incidence of arrhythmic events leading to a specific change in treatment.

Time frame: within the first weeks after the procedure, an average of 4 weeks

Type of arrhythmic events and treatment modification

Type of arrhythmic events leading to a specific change in treatment.

Time frame: within the first weeks after the procedure, an average of 4 weeks

Secondary Outcomes

Number of participants with pacemaker

Incidence of permanent pacemaker implantation after the procedure.

Time frame: Through study completion, an average of 5 years

Number of participants with treatment modification

Number of participants who required change in their medication (anticoagulation, antiarrhythmic) after the procedure.

Time frame: Through study completion, an average of 5 years

Data from ClinicalTrials.gov

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