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

NCT02323503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 289

Last updated 2020-03-31

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

CRT-D device replacement

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Daniel DG Gras, MD · Nouvelles Cliniques Nantaises, France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-09
Primary Completion
2020-02-12
Completion
2020-02-12

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02323503 on ClinicalTrials.gov