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

M

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

  • Subject has reviewed, signed and dated the informed consent form
  • 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
  • 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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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