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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bradycardia
• Intervention / Treatment: Device: JX- XFINE lead

• Study Type: Observational
• Enrollment (Anticipated): 129

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: MicroPort CRM

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: LXFP01 - SHAPE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No