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

Not yet recruiting

• Conditions: Bradycardia

• Registration Number: NCT05440071
• Lead Sponsor: MicroPort CRM

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-27
• Study First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Study First Posted: 2022-06-30
• Last Update Posted: 2022-06-30
• Study Start: 2022-09
• Primary Completion: 2023-10
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.	3 months
Electrical performances of the right atrial J-shape (JX model) XFINE endovascular at 3 months	3 months