Status:
UNKNOWN
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Lead Sponsor:
MicroPort CRM
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
Eligibility Criteria
Inclusion
- Subject has reviewed, signed and dated the informed consent form
- Subject newly implanted (de novo) with a JX XFINE within 10 days, connected to a dual chamber (DR) pacemaker from MicroPort CRM S.r.l and any commercially available IS-1 right ventricular lead
- Subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol.
Exclusion
- Subjects with documented permanent or persistent AF
- Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
- Subject has had any pacing or ICD system implants
- 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)
- Age less than 18 years old, incapacitated or under guardianship or kept in detention
- Life expectancy less than 1 year
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT05440071
Start Date
September 1 2022
End Date
September 1 2024
Last Update
June 30 2022
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