NCT Number: NCT02323503
Assessment of Ventricular Arrhythmia Risk After CRT-D Replacement for Patients With Primary Prevention Indication
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
OLV Aalst, Aalst, Belgium
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Assess the rate of patients with at least one sustained VTA after replacement
Time frame: up to two years
Secondary outcomes
-
Rate of patients with at least one VTA for 4 specific subgroups
Time frame: After the device replacement and after a minimum of two years follow-up (FU)
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
Other outcomes
-
Rate of patients with ventricular tachycardia or ventricular fibrillation events, with appropriate therapies
Time frame: After the device replacement and after a minimum of two years FU
-
Rate of patients with inappropriate therapies/diagnosis
Time frame: After the device replacement and after a minimum of two years FU
-
Baseline factor predictors of ventricular events
Time frame: After the device replacement and after a minimum of two years FU
-
Serious adverse events related to ventricular events / inappropriate therapies
Time frame: After the device replacement and after a minimum of two years FU
Sponsors and collaborators
Lead sponsor
Biotronik SE & Co. KG
Industry
Registry information
Official study title
BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias After CRT-D Replacement for Patients With Primary Prevention Indication
Acronym: BioCONTINUE
Important dates
- Study start
- 2015
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Dec 23, 2014
- Registry last updated
- Mar 31, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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