Safety and Electrical Performances of XFINE Leads (PERSEPOLIS)

MicroPort

Status: Completed

Conditions: Bradycardia

Treatments: Device: XFINE leads

Study type: Interventional

Funder types: Industry

Identifiers

NCT03922386

LBFX05 - PERSEPOLIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

JX model

Other group

Description:

Subjects implanted with an RA XFINE lead (JX model)

Treatment:

Device: XFINE leads

TX model

Other group

Description:

Subjects implanted with an RV XFINE lead (TX model)

Treatment:

Device: XFINE leads