Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
188 participants
INTERVENTIONAL
2019-09-09
2021-07-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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JX model
Subjects implanted with an RA XFINE lead (JX model)
XFINE leads
Pacemaker subjects with at least one XFINE passive lead
TX model
Subjects implanted with an RV XFINE lead (TX model)
XFINE leads
Pacemaker subjects with at least one XFINE passive lead
Interventions
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XFINE leads
Pacemaker subjects with at least one XFINE passive lead
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
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MicroPort CRM
INDUSTRY
Responsible Party
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Principal Investigators
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Alfredo Bardají, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Joan XXIII, Tarragona, Spain
Locations
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Centre Hospitalier de Cahors
Cahors, , France
CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital de la Croix-Rousse
Lyon, , France
Clinica Medica - Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Ospedale Santa Maria Nuova
Florence, , Italy
Clinica San Carlo
Milan, , Italy
Azienda Ospedaliera Santa Maria degli Angeli
Pordenone, , Italy
Ospedale Policlinico Casilino
Roma, , Italy
Ospedale Civile di Vigevano
Vigevano, , Italy
Ospedale Civile di Voghera
Voghera, , Italy
Centro Hospitalar do Baixo Vouga, E.P.E.
Aveiro, , Portugal
Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira
Creixomil, , Portugal
Centro Hospitalar de Leiria - Hospital de Santo André
Leiria, , Portugal
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, , Portugal
Hospital Universitari Joan XXIII
Tarragona, , Spain
Hospital Doctor Peset
Valencia, , Spain
Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
Leeds, , United Kingdom
Kingston Hospital
London, , United Kingdom
Lister Hospital
Stevenage, , United Kingdom
Countries
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Other Identifiers
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LBFX05 - PERSEPOLIS
Identifier Type: -
Identifier Source: org_study_id
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