NCT02323503: BioCONTINUE

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

Completed Last updated 31 March 2020

What this trial tests

trial testing CRT-D device replacement in Cardiac Resynchronization in 289 participants. Completed in 12 February 2020.

Timeline

9 June 2015

Primary endpoint
12 February 2020

12 February 2020

Quick facts

Lead sponsor	Biotronik SE & Co. KG
Status	Completed
Study type	OBSERVATIONAL
Enrollment	289
Start date	9 June 2015
Primary completion	12 February 2020
Estimated completion	12 February 2020
Sites	37 locations across France, Italy, Belgium, Israel, Germany, Hungary, Portugal, Spain

Drugs / interventions tested

• CRT-D device replacement

Conditions studied

• Cardiac Resynchronization — all drugs for Cardiac Resynchronization →
• Biventricular Pacemakers, Artificial — all drugs for Biventricular Pacemakers, Artificial →
• Cardioverter-Defibrillators, Implantable — all drugs for Cardioverter-Defibrillators, Implantable →
• Device Replacement — all drugs for Device Replacement →

Sponsor

Biotronik SE & Co. KG — full company profile →

Who can join

18 and older, any sex, with Cardiac Resynchronization or Biventricular Pacemakers, Artificial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. CRT-D replacement strategy: results of the BioCONTINUE study.
   Gras D, Clémenty N, Ploux S, Guyomar Y, et al · · 2023 · cited 4× · PMID 36459310 · DOI 10.1007/s10840-022-01440-5