Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922386
Other study ID # LBFX05 - PERSEPOLIS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2019
Est. completion date July 23, 2021

Study information

Verified date April 2023
Source MicroPort CRM
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 188
Est. completion date July 23, 2021
Est. primary completion date March 25, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
XFINE leads
Pacemaker subjects with at least one XFINE passive lead

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
MicroPort CRM

Countries where clinical trial is conducted

France,  Italy,  Portugal,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom from XFINE lead-related complications 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
Primary Electrical performances confirmation 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
See also
  Status Clinical Trial Phase
Completed NCT03294018 - Heart Rate Changes Following the Administration of Sugammadex
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT05440071 - PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Completed NCT02153242 - The Effects of Selective Site Right Ventricular Pacing
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00950287 - Detection of Neonatal Bradycardia N/A
Completed NCT00721136 - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation N/A
Completed NCT00286858 - Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Completed NCT00158925 - The EASYTRAK EPI Clinical Investigation Phase 3
Completed NCT00180557 - Austria Study - Analysis of Difference Between Active and Passive Fixation Leads Phase 4
Completed NCT01076348 - Model 4965 Post-Approval Study
Completed NCT04198220 - BIO|STREAM.ICM Obesity
Recruiting NCT05298748 - The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants N/A
Recruiting NCT04353960 - The Alaska Oculocardiac Reflex Study
Terminated NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing N/A
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT05935007 - Aveir DR Real-World Evidence Post-Approval Study
Recruiting NCT05932602 - AVEIR DR Coverage With Evidence Development (CED) Study
Recruiting NCT04075084 - Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
Recruiting NCT03008291 - His Bundle Pacing in Bradycardia and Heart Failure