Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication

Device Replacement Clinical Trial

— BioCONTINUE  

Official title:

BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323503
• Other study ID #: CR018
• Status: Completed
• Start date: June 9, 2015
• Est. completion date: February 12, 2020

Study information

• Verified date: June 2019
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Biventricular Pacemakers, Artificial
• Cardiac Resynchronization
• Cardioverter-Defibrillators, Implantable
• Device Replacement

Intervention

Device:
• CRT-D device replacement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Hungary,  Israel,  Italy,  Portugal,  Spain, 

Outcome

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)