Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

MicroPort CRM19 sites in 8 countries206 target enrollmentMarch 25, 2022

ConditionsBradycardia Remote Monitoring

Overview

Phase: N/A
Intervention: Not specified
Conditions: Bradycardia
Sponsor: MicroPort CRM
Enrollment: 206
Locations: 19
Primary Endpoint: Technical remote alerts documented at the M1-M3 visit
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.

Detailed Description

All patients will be included just after implantation and will then be followed during 48 months after inclusion. At each on-site or remote follow-up visit (1 to 3 months, 6, 12, 24 and 48 months), performances of the remote monitoring functions and the cardiac pacing system itself will be measured, and safety will be monitored during the whole clinical investigation duration.

Registry

clinicaltrials.gov

Start Date

March 25, 2022

End Date

July 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

MicroPort CRM

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient implanted according to the most recent guidelines from the ESC, for 20 days or less (de novo implantation, device upgrade to dual chamber or device replacement)
•Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM
•Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead
•Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVAT and the remote alerts) accepted by the patient and planned to be activated
•Patient reviewed, signed and dated the ICF

Exclusion Criteria

•Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)
•Patient with permanent AF
•Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
•Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
•Minor age patient (i.e. under 18 years of age)
•Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
•Patient unavailable for the follow-up visits scheduled
•Non-menopausal women

Outcomes

Primary Outcomes

Technical remote alerts documented at the M1-M3 visit

Time Frame: 1 to 3 months post-inclusion visit (M1-M3)

In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function at the inclusion and the M1-M3 visits

Time Frame: 1 to 3 months post-inclusion visit (M1-M3)

Right Atrial Autothreshold values at the inclusion and the M1-M3 visits

Time Frame: 1 to 3 months post-inclusion visit (M1-M3)

Secondary Outcomes

Right Ventricular Autothreshold values up to the M48 visit(48 months post-inclusion visit (M48))
Safety of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit(48 months post-inclusion visit (M48))
Right Atrial Autothreshold values up to the M48 visit(48 months post-inclusion visit (M48))
In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit(48 months post-inclusion visit (M48))
Technical remote alerts documented up to the M48 visit(48 months post-inclusion visit (M48))
Usability of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit(48 months post-inclusion visit (M48))
Electrical performances (pacing thresholds, impedance & minimum sensed amplitude) of ALIZEA, BOREA and CELEA pacemaker systems up to the M48 visit(48 months post-inclusion visit (M48))