Clinical trial NCT05165095: Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Official title: Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bradycardia
Remote Monitoring
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated (class I or II) for a dual chamber pacemaker (de novo implantation, device upgrade to dual chamber or device replacement), according to the most recent guidelines from the ESC.

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.

Eligibility criteria: Inclusion Criteria:

1. 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)
2. Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM
3. Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead
4. 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
5. Patient reviewed, signed and dated the ICF

Exclusion Criteria:

1. Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)
2. Patient with permanent AF
3. Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
4. 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)
5. Minor age patient (i.e. under 18 years of age)
6. Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
7. Patient unavailable for the follow-up visits scheduled
8. Non-menopausal women

Primary outcomes:
measure: Right Atrial Autothreshold values at the inclusion and the M1-M3 visits
timeFrame: 1 to 3 months post-inclusion visit (M1-M3)
measure: In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function at the inclusion and the M1-M3 visits
timeFrame: 1 to 3 months post-inclusion visit (M1-M3)
measure: Technical remote alerts documented at the M1-M3 visit
timeFrame: 1 to 3 months post-inclusion visit (M1-M3)
Secondary outcomes:
measure: Right Atrial Autothreshold values up to the M48 visit
timeFrame: 48 months post-inclusion visit (M48)
measure: In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit
timeFrame: 48 months post-inclusion visit (M48)
measure: Technical remote alerts documented up to the M48 visit
timeFrame: 48 months post-inclusion visit (M48)
measure: Right Ventricular Autothreshold values up to the M48 visit
timeFrame: 48 months post-inclusion visit (M48)
measure: Safety of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit
timeFrame: 48 months post-inclusion visit (M48)
measure: Electrical performances (pacing thresholds, impedance & minimum sensed amplitude) of ALIZEA, BOREA and CELEA pacemaker systems up to the M48 visit
timeFrame: 48 months post-inclusion visit (M48)
measure: Usability of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit
timeFrame: 48 months post-inclusion visit (M48)
Other outcomes:
Locations:
city: Krems
country: Austria
facility: Universitätsklinikum Krems
city: Wien
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Arlon
country: Belgium
facility: Clinique Saint Joseph
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Le Coudray
country: France
facility: CH Chartres
city: Marseille
country: France
facility: CHU Hôpital de la Timone
city: Nantes
country: France
facility: CHU Nantes
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Valence
country: France
facility: CH Valence
city: Hamburg
country: Germany
facility: Cardiologicum Hamburg
city: Pirna
country: Germany
facility: Cardiologicum Pirna
city: Rostock
country: Germany
facility: Kardiologische Praxis Dr. Trautwein & Dr. Placke
city: Venlo
country: Netherlands
facility: Ziekenhuis VieCuri Venlo
city: Amadora
country: Portugal
facility: Hospital Professor Doutor Fernando Fonseca
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
city: London
country: United Kingdom
facility: Kingston Hospital
city: Westcliff-on-Sea
country: United Kingdom
facility: Southend University Hospital
Study officials:
References: