PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
SHAPE
1 other identifier
observational
129
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJune 30, 2022
June 1, 2022
1.1 years
June 27, 2022
June 27, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Interventions
Pacemaker subjects implanted with one JX - XFINE passive pacing lead
Eligibility Criteria
Subject indicated for a de novo implantation of a dual chamber (DR) pacemaker as per Guidelines on cardiac pacing and cardiac resynchronization therapy.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MicroPort CRMlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2022
First Posted
June 30, 2022
Study Start
September 1, 2022
Primary Completion
October 1, 2023
Study Completion
September 1, 2024
Last Updated
June 30, 2022
Record last verified: 2022-06