Bradycardia
Conditions
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.
Interventions
DEVICEXFINE leads
Pacemaker subjects with at least one XFINE passive lead
Sponsors
MicroPort CRM
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France, Italy, Portugal, Spain, United Kingdom
Outcome results
None listed