Safety and Electrical Performances of XFINE Leads
- Conditions
- Bradycardia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 188
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Centre Hospitalier de Cahors
🇫🇷Cahors, France
CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Hôpital de la Croix-Rousse
🇫🇷Lyon, France
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, Italy
Scroll for more (9 remaining)Centre Hospitalier de Cahors🇫🇷Cahors, France