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Cardiac resynchronization therapy (CRT) has been shown to reduce heart failure (HF), hospitalizations and death in patients with left ventricular ejection fraction (LVEF) <35% and wide QRS. CRT provides electromechanical resynchronization and improves LV systolic function. The induced LV reverse remodeling or near normalization in LVEF to ≥45% is associated with a significant reduction in the risk of subsequent life-threatening ventricular tachyarrhythmias (VTA). And at the time of replacement, the need for defibrillator back-up after an event-free first CRT-D service-life for patients with improved LVEF is a controversy question.
80% of Implantable Cardioverter Defibrillator (ICD) patients implanted for primary prevention do not experience VTA during the life-time of their first device.
So, regarding patients implanted with a CRT-D for primary prevention at the time of first implantation, the question is will they experience VTA after their device replacement by another CRT-D.
The objective of this study is to describe, in a population of patients who had a primary prevention ICD indication at first implantation of a CRT-D, the relevance defibrillator back-up after the replacement of the first CRT-D. For that, the rate of patients with at least one sustained VTA detected by the CRT-D or a conventional surface ECG will be assessed after the device replacement.
Furthermore, the association between the baseline characteristics of the CRT-D population after replacement and the risk of subsequent VTA will be explored after a minimum of two years FU.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-D device replacement | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the rate of patients with at least one sustained VTA after replacement | up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with at least one VTA for 4 specific subgroups | Grp R[1-4]: LVEF ≥40% / <40% at the time of replacement and with / without previous VTA during the lifetime of their first CRT-D device | After the device replacement and after a minimum of two years follow-up (FU) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with ventricular tachycardia or ventricular fibrillation events, with appropriate therapies | After the device replacement and after a minimum of two years FU | |
| Rate of patients with inappropriate therapies/diagnosis | After the device replacement and after a minimum of two years FU |
Inclusion Criteria:
Exclusion Criteria:
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Patients initially implanted with a CRT-D (cardiac resynchronization therapy with defibrillator) device for primary prevention indication for defibrillation, requiring a device replacement by another CRT-D because of battery depletion
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| Name | Affiliation | Role |
|---|---|---|
| Daniel DG Gras, MD | Nouvelles Cliniques Nantaises, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Aalst | Aalst | Belgium | ||||
| CH d'Annecy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36459310 | Derived | Gras D, Clementy N, Ploux S, Guyomar Y, Legallois D, Segreti L, Blangy H, Laurent G, Bizeau O, Fauquembergue S, Lazarus A; BioCONTINUE study Investigators. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol. 2023 Aug;66(5):1201-1209. doi: 10.1007/s10840-022-01440-5. Epub 2022 Dec 2. |
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| Baseline factor predictors of ventricular events | After the device replacement and after a minimum of two years FU |
| Serious adverse events related to ventricular events / inappropriate therapies | After the device replacement and after a minimum of two years FU |
| Annecy |
| France |
| Hôpital de la Cavale Blanche | Brest | France |
| CHU Caen | Caen | France |
| CHU Montpied | Clermont-Ferrand | France |
| CH Du Bocage | Dijon | France |
| CHRU de Lille | Lille | France |
| CHU de Limoges | Limoges | France |
| CH Saint Philibert | Lomme | France |
| Cliniques du Tonkin, de la Sauvegarde et Protestante | Lyon | France |
| Clinique Clairval | Marseille | France |
| Hôpital de la Timone | Marseille | France |
| Hôpital Mercy | Metz | France |
| CHU Montpellier | Montpellier | France |
| CHU Nancy | Nancy | France |
| Nouvelles Cliniques Nantaises | Nantes | France |
| CH de la Pitié Salpétrière | Paris | France |
| CHU Pessac | Pessac | France |
| CHU de Rennes | Rennes | France |
| CHU Hôpital CHarles Nicolle | Rouen | France |
| CH de Saint-Etienne | Saint-Etienne | France |
| CHU Toulouse | Toulouse | 31403 | France |
| CHU Tours | Tours | France |
| Schuechtermann-Klinik | Bad Rothenfelde | Germany |
| Stadtisches Klinikum Brandenburg | Brandenburg | Germany |
| DRK-Krankenhaus Moelln Ratzeburg | Ratzeburg | Germany |
| Cardiological Praxis | Rostock | Germany |
| Semmelweis University | Budapest | Hungary |
| Barzilai Medical Center | Ashkelon | Israel |
| Ospedale Versilia | Lido di Camaiore | Italy |
| Clinica Mediterranea | Naples | Italy |
| Ospedale Santa Chiara | Pisa | Italy |
| Hospital de Santa Maria | Lisbon | Portugal |
| Hospital de Santa Marta | Lisbon | Portugal |
| Hospital Universitario de Burgos | Burgos | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | Spain |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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