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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05440071

Acronym

SHAPE

Enrollment

129

Registered

2022-06-30

Start date

2022-09-30

Completion date

2024-09-30

Last updated

2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia

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.

Interventions

DEVICEJX- XFINE lead

Pacemaker subjects implanted with one JX - XFINE passive pacing lead

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026