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

March 30, 2020 updated by: Biotronik SE & Co. KG

BIOtronik Study to Assess the CONTINUation of Existing Risk of Ventricular Arrhythmias 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

289

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • OLV Aalst
  • France
      • Annecy, France
        • CH d'Annecy
      • Brest, France
        • Hopital De La Cavale Blanche
      • Caen, France
        • CHU caen
      • Clermont-Ferrand, France
        • CHU Montpied
      • Dijon, France
        • CH Du Bocage
      • Lille, France
        • CHRU de Lille
      • Limoges, France
        • CHU de Limoges
      • Lomme, France
        • CH Saint Philibert
      • Lyon, France
        • Cliniques du Tonkin, de la Sauvegarde et Protestante
      • Marseille, France
        • Hopital de la Timone
      • Marseille, France
        • Clinique Clairval
      • Metz, France
        • Hopital Mercy
      • Montpellier, France
        • CHU Montpellier
      • Nancy, France
        • Chu Nancy
      • Nantes, France
        • Nouvelles Cliniques Nantaises
      • Paris, France
        • CH de la Pitié Salpétrière
      • Pessac, France
        • Chu Pessac
      • Rennes, France
        • CHU de Rennes
      • Rouen, France
        • CHU Hôpital Charles Nicolle
      • Saint-Etienne, France
        • CH de Saint-Etienne
      • Toulouse, France, 31403
        • CHU Toulouse
      • Tours, France
        • Chu Tours
  • Germany
      • Bad Rothenfelde, Germany
        • Schuechtermann-Klinik
      • Brandenburg, Germany
        • Städtisches Klinikum Brandenburg
      • Ratzeburg, Germany
        • DRK-Krankenhaus Moelln Ratzeburg
      • Rostock, Germany
        • Cardiological Praxis
  • Hungary
      • Budapest, Hungary
        • Semmelweis University
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
  • Italy
      • Lido di Camaiore, Italy
        • Ospedale Versilia
      • Napoli, Italy
        • Clinica Mediterranea
      • Pisa, Italy
        • Ospedale Santa Chiara
  • Portugal
      • Lisboa, Portugal
        • Hospital de Santa Maria
      • Lisboa, Portugal
        • Hospital De Santa Marta
  • Spain
      • Burgos, Spain
        • Hospital Universitario de Burgos
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Valladolid, Spain
        • Hospital Clínico Universitario de Valladolid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients initially implanted with a CRT-D (cardiac resynchronization therapy with defibrillator) device for primary prevention indication for defibrillation, requiring a device replacement by another CRT-D because of battery depletion

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the rate of patients with at least one sustained VTA after replacement
Time Frame: up to two years
up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After the device replacement and after a minimum of two years follow-up (FU)

Other Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
After the device replacement and after a minimum of two years FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik SE & Co. KG

Investigators

  • Principal Investigator: Daniel DG Gras, MD, Nouvelles Cliniques Nantaises, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2015

Primary Completion (Actual)

February 12, 2020

Study Completion (Actual)

February 12, 2020

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 22, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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