Safety and Electrical Performances of XFINE Leads

Study Overview
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Brief Summary
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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
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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.

Official Title
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ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study

Conditions
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Bradycardia

Intervention / Treatment
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* Device: XFINE leads


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: JX model<br>Subjects implanted with an RA XFINE lead (JX model) | Device: XFINE leads<br>* Pacemaker subjects with at least one XFINE passive lead<br>|
| Other: TX model<br>Subjects implanted with an RV XFINE lead (TX model) | Device: XFINE leads<br>* Pacemaker subjects with at least one XFINE passive lead<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from XFINE lead-related complications | This endpoint will confirm the freedom from XFINE Lead-Related Complications (LRC) up to the 6 months post implant follow-up. The anticipated complication-free rate is 0.95, and will be compared against an a priori performance goal of 0.85. An XFINE Lead-Related Complication (LRC) is defined as any XFINE (RA and/or RV) lead-related Serious Adverse Device Effect (SADE) that resulted in subject death or required an additional invasive intervention (excluding re-programming) and occurred within 6 months post implant. This endpoint will be assessed independently for each lead model. | at 6 months post implant | 
| Electrical performances confirmation | This endpoint will characterize the XFINE lead performances in ensuring adequate Pacing Capture Thresholds (PCT) through 6 months post implant follow-up. The values assessed in this analysis are the PCT measured at 0.50 ms (or less) pulse width at 6 months follow-up visit. The PCT measured at 6 months will be compared against an a priori performance goal of 1.0V/0.5 ms, assuming an expected pacing threshold at 6 months of 0.8V/0.5 ms with a standard deviation of 0.5V. This endpoint will be assessed independently for each lead model. | at 6 months post implant |