Safety and Electrical Performances of XFINE Leads

Bradycardia Clinical Trial

— PERSEPOLIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922386
• Other study ID #: LBFX05 - PERSEPOLIS
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bradycardia

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