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

Completed

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

• Registration Number: NCT02323503
• Lead Sponsor: Biotronik SE & Co. KG

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.

Study Timeline

• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Study Start: 2015-06-09
• Status Verified: 2019-06
• Primary Completion: 2020-02-12
• Study Completion: 2020-02-12
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the rate of patients with at least one sustained VTA after replacement	up to two years

Secondary Outcome Measures

Name	Time	Method
Rate of patients with at least one VTA for 4 specific subgroups	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

Trial Locations

Locations (37)

CH de la Pitié Salpétrière; 🇫🇷 Paris, France

CHU Montpied; 🇫🇷 Clermont-Ferrand, France

OLV Aalst; 🇧🇪 Aalst, Belgium

CHU Caen; 🇫🇷 Caen, France

CH Du Bocage; 🇫🇷 Dijon, France

CHRU de Lille; 🇫🇷 Lille, France

CHU de Limoges; 🇫🇷 Limoges, France

CH Saint Philibert; 🇫🇷 Lomme, France

CHU Nancy; 🇫🇷 Nancy, France

Nouvelles Cliniques Nantaises; 🇫🇷 Nantes, France

Cliniques du Tonkin, de la Sauvegarde et Protestante; 🇫🇷 Lyon, France

Hôpital de la Timone; 🇫🇷 Marseille, France

Hôpital Mercy; 🇫🇷 Metz, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Pessac; 🇫🇷 Pessac, France

CHU de Rennes; 🇫🇷 Rennes, France

Schuechtermann-Klinik; 🇩🇪 Bad Rothenfelde, Germany

CHU Hôpital CHarles Nicolle; 🇫🇷 Rouen, France

CH de Saint-Etienne; 🇫🇷 Saint-Etienne, France

CHU Tours; 🇫🇷 Tours, France

Cardiological Praxis; 🇩🇪 Rostock, Germany

Hospital de Santa Marta; 🇵🇹 Lisboa, Portugal

Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

Ospedale Versilia; 🇮🇹 Lido di Camaiore, Italy

CH d'Annecy; 🇫🇷 Annecy, France

Hôpital de la Cavale Blanche; 🇫🇷 Brest, France

Clinique Clairval; 🇫🇷 Marseille, France

CHU Toulouse; 🇫🇷 Toulouse, France

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

DRK-Krankenhaus Moelln Ratzeburg; 🇩🇪 Ratzeburg, Germany

Ospedale Santa Chiara; 🇮🇹 Pisa, Italy

Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal

Semmelweis University; 🇭🇺 Budapest, Hungary

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain

Stadtisches Klinikum Brandenburg; 🇩🇪 Brandenburg, Germany

Clinica Mediterranea; 🇮🇹 Napoli, Italy