Safety and Electrical Performances of XFINE Leads

Not Applicable

Completed

• Conditions: Bradycardia
• Interventions: Device: XFINE leads

• Registration Number: NCT03922386
• Lead Sponsor: MicroPort CRM

Brief 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.

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 Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-22
• Study Start: 2019-09-09
• Primary Completion: 2021-03-25
• Study Completion: 2021-07-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JX model	XFINE leads	Subjects implanted with an RA XFINE lead (JX model)
TX model	XFINE leads	Subjects implanted with an RV XFINE lead (TX model)

Primary Outcome Measures

Name	Time	Method
Freedom from XFINE lead-related complications	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	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.

Trial Locations

Locations (19)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Clinica Medica - Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

Centre Hospitalier de Cahors; 🇫🇷 Cahors, France

Hôpital de la Croix-Rousse; 🇫🇷 Lyon, France

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, Italy

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, Portugal

Hospital Universitari Joan XXIII; 🇪🇸 Tarragona, Spain

Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Hospital Doctor Peset; 🇪🇸 Valencia, Spain

Kingston Hospital; 🇬🇧 London, United Kingdom

Lister Hospital; 🇬🇧 Stevenage, United Kingdom