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

Bradycardia Clinical Trial

— SHAPE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05440071
• Other study ID #: LXFP01 - SHAPE
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2022
• Source: MicroPort CRM
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 129
• Est. completion date: September 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• JX- XFINE lead
Pacemaker subjects implanted with one JX - XFINE passive pacing lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.		3 months
Primary	Electrical performances of the right atrial J-shape (JX model) XFINE endovascular at 3 months		3 months