Clinical trial NCT03922386: Safety and Electrical Performances of XFINE Leads
Official title: ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bradycardia
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2019-04-22
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study.
Primary purpose: OTHER

Brief summary: The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.

Detailed description: All subjects will be followed until 12 months follow-up post implant.

At each follow-up visits (3, 6 and 12 months), electrical performances will be measured and safety will be monitored during the whole study duration.

Eligibility criteria: Inclusion Criteria:

1. Any subject newly implanted according to the most recent guidelines from the European Society of Cardiology (ESC) for less than10 days with:

   * a Single Chamber (SR) or a Dual Chamber (DR) pacemaker from Microport CRM S.r.l.
   * any right atrial and/or right ventricular XFINE lead
2. Have reviewed, signed and dated the informed consent

Exclusion Criteria:

1. Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
2. Contraindication to a maximum single dose of 310 µg Dexamethasone Sodium Phosphate (DSP)
3. Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) only for subject with DR pacemaker
4. Active myocarditis, pocket and/or lead infection
5. Age less than 18 years old or under guardianship or kept in detention
6. Life expectancy less than 1 year
7. Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method
8. Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate

Primary outcomes:
measure: Freedom from XFINE lead-related complications
timeFrame: at 6 months post implant
measure: Electrical performances confirmation
timeFrame: at 6 months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Cahors
country: France
facility: Centre Hospitalier de Cahors
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Firenze
country: Italy
facility: Clinica Medica - Azienda Ospedaliero Universitaria Careggi
city: Firenze
country: Italy
facility: Ospedale Santa Maria Nuova
city: Milano
country: Italy
facility: Clinica San Carlo
city: Pordenone
country: Italy
facility: Azienda Ospedaliera Santa Maria degli Angeli
city: Roma
country: Italy
facility: Ospedale Policlinico Casilino
city: Vigevano
country: Italy
facility: Ospedale Civile di Vigevano
city: Voghera
country: Italy
facility: Ospedale Civile di Voghera
city: Aveiro
country: Portugal
facility: Centro Hospitalar do Baixo Vouga, E.P.E.
city: Creixomil
country: Portugal
facility: Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira
city: Leiria
country: Portugal
facility: Centro Hospitalar de Leiria - Hospital de Santo André
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
city: London
country: United Kingdom
facility: Kingston Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
Study officials:
affiliation: Hospital Universitari Joan XXIII, Tarragona, Spain
name: Alfredo Bardají, Dr.
role: PRINCIPAL_INVESTIGATOR
References: