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

Biotronik

Status: Completed

Conditions: Cardioverter-Defibrillators, Implantable; Device Replacement; Biventricular Pacemakers, Artificial; Cardiac Resynchronization

Treatments: Device: CRT-D device replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT02323503

CR018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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