Device Replacement Clinical Trial
— BioCONTINUEOfficial title:
BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
NCT number | NCT02323503 |
Other study ID # | CR018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 9, 2015 |
Est. completion date | February 12, 2020 |
Verified date | June 2019 |
Source | Biotronik SE & Co. KG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 289 |
Est. completion date | February 12, 2020 |
Est. primary completion date | February 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient with primary prevention indication for defibrillation at the time of the first CRT-D implantation - Patient implanted as first replacement by a CRT-D device (CRT-D by CRT-D) - Lifetime of the previous CRT-D > 3 years - Patient willing and able to comply with the protocol and who has provided written informed consent - Patient whose medical situation is stable. Exclusion Criteria: - Patient with an ICD lead under advisory (e.g. Fidelis lead) - Right or left ventricular leads exchange during CRT-D replacement - Non functional atrial (except for patient with chronic AF) or right/left ventricular leads - Life expectancy < 1 year - Age < 18 years - Pregnant woman or woman who plan to become pregnant during the trial - Participation in another interventional clinical study |
Country | Name | City | State |
---|---|---|---|
Belgium | OLV Aalst | Aalst | |
France | CH d'Annecy | 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 | |
France | CHU Tours | Tours | |
Germany | Schuechtermann-Klinik | Bad Rothenfelde | |
Germany | Stadtisches Klinikum Brandenburg | Brandenburg | |
Germany | DRK-Krankenhaus Moelln Ratzeburg | Ratzeburg | |
Germany | Cardiological Praxis | Rostock | |
Hungary | Semmelweis University | Budapest | |
Israel | Barzilai Medical Center | Ashkelon | |
Italy | Ospedale Versilia | Lido di Camaiore | |
Italy | Clinica Mediterranea | Napoli | |
Italy | Ospedale Santa Chiara | Pisa | |
Portugal | Hospital de Santa Maria | Lisboa | |
Portugal | Hospital de Santa Marta | Lisboa | |
Spain | Hospital Universitario de Burgos | Burgos | |
Spain | Hospital Universitario Marques de Valdecilla | Santander | |
Spain | Hospital Clinico Universitario de Valladolid | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Biotronik SE & Co. KG |
Belgium, France, Germany, Hungary, Israel, Italy, Portugal, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | ||
Other | Rate of patients with inappropriate therapies/diagnosis | After the device replacement and after a minimum of two years FU | ||
Other | Baseline factor predictors of ventricular events | After the device replacement and after a minimum of two years FU | ||
Other | Serious adverse events related to ventricular events / inappropriate therapies | After the device replacement and after a minimum of two years FU | ||
Primary | Assess the rate of patients with at least one sustained VTA after replacement | up to two years | ||
Secondary | 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) |
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---|---|---|---|
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