Safety and Electrical Performances of XFINE Leads

The purpose of the study is to confirm the safety and the electrical performances of the XFINE passive pacing leads, for both right ventricular (RV) straight models and right atrial (RA) J-shape models, up to 12 months follow-up post implant.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de Cahors, Cahors, France

About this study

All subjects will be followed until 12 months follow-up post implant.

At each follow-up visits (3, 6 and 12 months), electrical performances will be measured and safety will be monitored during the whole study duration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any subject newly implanted according to the most recent guidelines from the European Society of Cardiology (ESC) for less than10 days with:

a Single Chamber (SR) or a Dual Chamber (DR) pacemaker from Microport CRM S.r.l.
any right atrial and/or right ventricular XFINE lead
Have reviewed, signed and dated the informed consent

Exclusion criteria

Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
Contraindication to a maximum single dose of 310 µg Dexamethasone Sodium Phosphate (DSP)
Tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) only for subject with DR pacemaker
Active myocarditis, pocket and/or lead infection
Age less than 18 years old or under guardianship or kept in detention
Life expectancy less than 1 year
Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method
Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate

Treatment and study plan

XFINE leads

Device

Pacemaker subjects with at least one XFINE passive lead

Primary outcomes

Freedom from XFINE lead-related complications

Time frame: at 6 months post implant

This endpoint will confirm the freedom from XFINE Lead-Related Complications (LRC) up to the 6 months post implant follow-up. The anticipated complication-free rate is 0.95, and will be compared against an a priori performance goal of 0.85.

An XFINE Lead-Related Complication (LRC) is defined as any XFINE (RA and/or RV) lead-related Serious Adverse Device Effect (SADE) that resulted in subject death or required an additional invasive intervention (excluding re-programming) and occurred within 6 months post implant. This endpoint will be assessed independently for each lead model.
Electrical performances confirmation

Time frame: at 6 months post implant

This endpoint will characterize the XFINE lead performances in ensuring adequate Pacing Capture Thresholds (PCT) through 6 months post implant follow-up. The values assessed in this analysis are the PCT measured at 0.50 ms (or less) pulse width at 6 months follow-up visit. The PCT measured at 6 months will be compared against an a priori performance goal of 1.0V/0.5 ms, assuming an expected pacing threshold at 6 months of 0.8V/0.5 ms with a standard deviation of 0.5V. This endpoint will be assessed independently for each lead model.

Sponsors and collaborators

Lead sponsor

MicroPort CRM

Industry

Registry information

Official study title

ProspEctive Record of Safety and Electrical Performances Of XFINE Leads: an International Study

Acronym: PERSEPOLIS

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Apr 22, 2019
Registry last updated: Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed