Clinical trial NCT02323503: Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
Official title: BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Resynchronization
Biventricular Pacemakers, Artificial
Cardioverter-Defibrillators, Implantable
Device Replacement
Keywords: CRT-D
replacement
primary prevention
ventricular tachyarrhythmias
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess the rate of patients with at least one sustained VTA after replacement
timeFrame: up to two years
Secondary outcomes:
measure: Rate of patients with at least one VTA for 4 specific subgroups
timeFrame: After the device replacement and after a minimum of two years follow-up (FU)
Other outcomes:
measure: Rate of patients with ventricular tachycardia or ventricular fibrillation events, with appropriate therapies
timeFrame: After the device replacement and after a minimum of two years FU
measure: Rate of patients with inappropriate therapies/diagnosis
timeFrame: After the device replacement and after a minimum of two years FU
measure: Baseline factor predictors of ventricular events
timeFrame: After the device replacement and after a minimum of two years FU
measure: Serious adverse events related to ventricular events / inappropriate therapies
timeFrame: After the device replacement and after a minimum of two years FU
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
city: Annecy
country: France
facility: CH d'Annecy
city: Brest
country: France
facility: Hôpital de la Cavale Blanche
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU Montpied
city: Dijon
country: France
facility: CH Du Bocage
city: Lille
country: France
facility: CHRU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Lomme
country: France
facility: CH Saint Philibert
city: Lyon
country: France
facility: Cliniques du Tonkin, de la Sauvegarde et Protestante
city: Marseille
country: France
facility: Clinique Clairval
city: Marseille
country: France
facility: Hôpital de la Timone
city: Metz
country: France
facility: Hôpital Mercy
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Paris
country: France
facility: CH de la Pitié Salpétrière
city: Pessac
country: France
facility: CHU Pessac
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU Hôpital CHarles Nicolle
city: Saint-Etienne
country: France
facility: CH de Saint-Etienne
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Bad Rothenfelde
country: Germany
facility: Schuechtermann-Klinik
city: Brandenburg
country: Germany
facility: Stadtisches Klinikum Brandenburg
city: Ratzeburg
country: Germany
facility: DRK-Krankenhaus Moelln Ratzeburg
city: Rostock
country: Germany
facility: Cardiological Praxis
city: Budapest
country: Hungary
facility: Semmelweis University
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Lido di Camaiore
country: Italy
facility: Ospedale Versilia
city: Napoli
country: Italy
facility: Clinica Mediterranea
city: Pisa
country: Italy
facility: Ospedale Santa Chiara
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
affiliation: Nouvelles Cliniques Nantaises, France
name: Daniel DG Gras, MD
role: PRINCIPAL_INVESTIGATOR
References: