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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JX model | Other | Subjects implanted with an RA XFINE lead (JX model) |
|
| TX model | Other | Subjects implanted with an RV XFINE lead (TX model) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XFINE leads | Device | Pacemaker subjects with at least one XFINE passive lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Any subject newly implanted according to the most recent guidelines from the European Society of Cardiology (ESC) for less than10 days with:
Have reviewed, signed and dated the informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alfredo BardajÃ, Dr. | Hospital Universitari Joan XXIII, Tarragona, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de Cahors | Cahors | France | ||||
| CHU de Clermont-Ferrand |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Post market, multicenter, international, prospective, open label, two arms and longitudinal non comparative non randomized study.
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| Clermont-Ferrand |
| France |
| Hôpital de la Croix-Rousse | Lyon | France |
| Clinica Medica - Azienda Ospedaliero Universitaria Careggi | Florence | Italy |
| Ospedale Santa Maria Nuova | Florence | Italy |
| Clinica San Carlo | Milan | 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 |
| Hospital Doctor Peset | Valencia | Spain |
| Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary | Leeds | United Kingdom |
| Kingston Hospital | London | United Kingdom |
| Lister Hospital | Stevenage | United Kingdom |
| D013568 |
| Pathological Conditions, Signs and Symptoms |