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Status unknownNCT05440071SHAPEUpdated Jun 30, 2022

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

An observational study in Bradycardia, sponsored by MicroPort CRM. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.

Sponsored by MicroPort CRM · Observational

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
129
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Bradycardia

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03

In context

Bradycardia

306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.

This study's planned enrollment of 129 is below the median of 257 across 129 observational studies indexed under Bradycardia.

Browse Bradycardia studies →

Lead sponsor

MicroPort CRM is the lead sponsor of 24 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subject indicated for a de novo implantation of a dual chamber (DR) pacemaker as per Guidelines on cardiac pacing and cardiac resynchronization therapy.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
129 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Interventions

  • DeviceJX- XFINE lead

    Pacemaker subjects implanted with one JX - XFINE passive pacing lead

06

What researchers measure

Primary outcomes

  1. Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.

    Time frame: 3 months

  2. Electrical performances of the right atrial J-shape (JX model) XFINE endovascular at 3 months

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05440071
Lead sponsor
MicroPort CRM
Responsible party
Sponsor
First posted
Jun 30, 2022
Start date
Sep 2022 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jun 30, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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