NCT05440071
Not yet recruiting
Not Applicable
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
MicroPort CRM0 sites129 target enrollmentSeptember 2022
ConditionsBradycardia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bradycardia
- Sponsor
- MicroPort CRM
- Enrollment
- 129
- Primary Endpoint
- Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
Time Frame: 3 months
Electrical performances of the right atrial J-shape (JX model) XFINE endovascular at 3 months
Time Frame: 3 months
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