Phase
Condition
Arrhythmia
Heart Defect
Heart Disease
Treatment
Pacemaker implantation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient implanted according to the most recent guidelines from the ESC, for 20 daysor less (de novo implantation, device upgrade to dual chamber or device replacement)
Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker fromMicroPort CRM
Patient implanted with any active or passive CE marked bipolar RA lead, and anyactive or passive CE marked bipolar RV lead
Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVATand the remote alerts) accepted by the patient and planned to be activated
Patient reviewed, signed and dated the ICF
Exclusion
Exclusion Criteria:
Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse widthof 0.5 ms or below)
Patient with permanent AF
Patient already enrolled in another clinical investigation that could confound theresults of this clinical investigation (e.g., clinical investigations involvingintra-cardiac device)
Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a singledose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspidreplacement heart valve or with a significant tricuspid valve disease that may leadto future replacement heart valve surgery)
Minor age patient (i.e. under 18 years of age)
Incapacitated patient, under guardianship, kept in detention, refusing to cooperateor not able to understand the purpose of this clinical investigation
Patient unavailable for the follow-up visits scheduled
Non-menopausal women
Study Design
Study Description
Connect with a study center
Universitätsklinikum Krems
Krems,
AustriaActive - Recruiting
Allgemeines Krankenhaus Wien
Wien,
AustriaActive - Recruiting
Clinique Saint Joseph
Arlon,
BelgiumActive - Recruiting
CHU Bordeaux
Bordeaux,
FranceActive - Recruiting
CH Chartres
Le Coudray,
FranceActive - Recruiting
CHU Hôpital de la Timone
Marseille,
FranceActive - Recruiting
CHU Nantes
Nantes,
FranceActive - Recruiting
Clinique Pasteur Toulouse
Toulouse,
FranceActive - Recruiting
CH Valence
Valence,
FranceActive - Recruiting
Cardiologicum Hamburg
Hamburg,
GermanyActive - Recruiting
Cardiologicum Pirna
Pirna,
GermanyActive - Recruiting
Kardiologische Praxis Dr. Trautwein & Dr. Placke
Rostock,
GermanyActive - Recruiting
Ziekenhuis VieCuri Venlo
Venlo,
NetherlandsActive - Recruiting
Hospital Professor Doutor Fernando Fonseca
Amadora,
PortugalActive - Recruiting
Hospital Arquitecto Marcide
Ferrol,
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda,
SpainActive - Recruiting
Basildon University Hospital
Basildon,
United KingdomSite Not Available
Kingston Hospital
London,
United KingdomActive - Recruiting
Southend University Hospital
Westcliff-on-Sea,
United KingdomActive - Recruiting
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