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

NCT ID: NCT02323503

Last Updated: 2020-03-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 289 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-09
• Study Completion Date: 2020-02-12

Brief 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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

CRT-D device replacement

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel DG Gras, MD

Role: PRINCIPAL_INVESTIGATOR

Nouvelles Cliniques Nantaises, France

Locations

OLV Aalst

Aalst, , Belgium

CH d'Annecy

Annecy, , France

Hôpital de la Cavale Blanche

Brest, , France

CHU Caen

Caen, , France

CHU Montpied

Clermont-Ferrand, , France

CH Du Bocage

Dijon, , France

CHRU de Lille

Lille, , France

CHU de Limoges

Limoges, , France

CH Saint Philibert

Lomme, , France

Cliniques du Tonkin, de la Sauvegarde et Protestante

Lyon, , France

Clinique Clairval

Marseille, , France

Hôpital de la Timone

Marseille, , France

Hôpital Mercy

Metz, , France

CHU Montpellier

Montpellier, , France

CHU Nancy

Nancy, , France

Nouvelles Cliniques Nantaises

Nantes, , France

CH de la Pitié Salpétrière

Paris, , France

CHU Pessac

Pessac, , France

CHU de Rennes

Rennes, , France

CHU Hôpital CHarles Nicolle

Rouen, , France

CH de Saint-Etienne

Saint-Etienne, , France

CHU Toulouse

Toulouse, , France

CHU Tours

Tours, , France

Schuechtermann-Klinik

Bad Rothenfelde, , Germany

Stadtisches Klinikum Brandenburg

Brandenburg, , Germany

DRK-Krankenhaus Moelln Ratzeburg

Ratzeburg, , Germany

Cardiological Praxis

Rostock, , Germany

Semmelweis University

Budapest, , Hungary

Barzilai Medical Center

Ashkelon, , Israel

Ospedale Versilia

Lido di Camaiore, , Italy

Clinica Mediterranea

Napoli, , Italy

Ospedale Santa Chiara

Pisa, , Italy

Hospital de Santa Maria

Lisbon, , Portugal

Hospital de Santa Marta

Lisbon, , Portugal

Hospital Universitario de Burgos

Burgos, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Clinico Universitario de Valladolid

Valladolid, , Spain

Countries

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

References

Gras D, Clementy N, Ploux S, Guyomar Y, Legallois D, Segreti L, Blangy H, Laurent G, Bizeau O, Fauquembergue S, Lazarus A; BioCONTINUE study Investigators. CRT-D replacement strategy: results of the BioCONTINUE study. J Interv Card Electrophysiol. 2023 Aug;66(5):1201-1209. doi: 10.1007/s10840-022-01440-5. Epub 2022 Dec 2.

Reference Type: DERIVED

PMID: 36459310 (View on PubMed)

Other Identifiers

CR018

Identifier Type: -

Identifier Source: org_study_id