Safety and Electrical Performances of XFINE Leads (PERSEPOLIS)

April 5, 2023 updated by: MicroPort CRM

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Cahors, France
        • Centre Hospitalier de Cahors
      • Clermont-Ferrand, France
        • CHU de Clermont-Ferrand
      • Lyon, France
        • Hôpital de la Croix-Rousse
  • Italy
      • Firenze, Italy
        • Clinica Medica - Azienda Ospedaliero Universitaria Careggi
      • Firenze, Italy
        • Ospedale Santa Maria Nuova
      • Milano, Italy
        • Clinica San Carlo
      • Pordenone, Italy
        • Azienda Ospedaliera Santa Maria Degli Angeli
      • Roma, Italy
        • Ospedale Policlinico Casilino
      • Vigevano, Italy
        • Ospedale Civile di Vigevano
      • Voghera, Italy
        • Ospedale Civile di Voghera
  • Portugal
      • Aveiro, Portugal
        • Centro Hospitalar do Baixo Vouga, E.P.E.
      • Creixomil, Portugal
        • Centro Hospitalar do Alto Ave - Hospital da Senhora da Oliveira
      • Leiria, Portugal
        • Centro Hospitalar de Leiria - Hospital de Santo André
      • Vila Nova De Gaia, Portugal
        • Centro Hospitalar Vila Nova de Gaia/Espinho
  • Spain
      • Tarragona, Spain
        • Hospital Universitari Joan XXIII
      • Valencia, Spain
        • Hospital Doctor Peset
  • United Kingdom
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
      • London, United Kingdom
        • Kingston Hospital
      • Stevenage, United Kingdom
        • Lister Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. Have reviewed, signed and dated the informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: JX model
Subjects implanted with an RA XFINE lead (JX model)
Device: XFINE leads
Pacemaker subjects with at least one XFINE passive lead
Other: TX model
Subjects implanted with an RV XFINE lead (TX model)
Device: XFINE leads
Pacemaker subjects with at least one XFINE passive lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 6 months post implant
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.
at 6 months post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MicroPort CRM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2019

Primary Completion (Actual)

March 25, 2021

Study Completion (Actual)

July 23, 2021

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBFX05 - PERSEPOLIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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