PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead (SHAPE)

MicroPort

Status: Not yet enrolling

Conditions: Bradycardia

Treatments: Device: JX- XFINE lead

Study type: Observational

Funder types: Industry

Identifiers

NCT05440071

LXFP01 - SHAPE

Details and patient eligibility

About

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.

Enrollment: 129 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has reviewed, signed and dated the informed consent form
2. 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
3. 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

1. Subjects with documented permanent or persistent AF
2. Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
3. Subject has had any pacing or ICD system implants
4. 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)
5. Age less than 18 years old, incapacitated or under guardianship or kept in detention
6. Life expectancy less than 1 year