Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02323503
Other study ID # CR018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 9, 2015
Est. completion date February 12, 2020

Study information

Verified date June 2019
Source Biotronik SE & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 289
Est. completion date February 12, 2020
Est. primary completion date February 12, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
CRT-D device replacement


Locations

Country Name City State
Belgium OLV Aalst Aalst
France 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
Germany Schuechtermann-Klinik Bad Rothenfelde
Germany Stadtisches Klinikum Brandenburg Brandenburg
Germany DRK-Krankenhaus Moelln Ratzeburg Ratzeburg
Germany Cardiological Praxis Rostock
Hungary Semmelweis University Budapest
Israel Barzilai Medical Center Ashkelon
Italy Ospedale Versilia Lido di Camaiore
Italy Clinica Mediterranea Napoli
Italy Ospedale Santa Chiara Pisa
Portugal Hospital de Santa Maria Lisboa
Portugal Hospital de Santa Marta Lisboa
Spain Hospital Universitario de Burgos Burgos
Spain Hospital Universitario Marques de Valdecilla Santander
Spain Hospital Clinico Universitario de Valladolid Valladolid

Sponsors (1)

Lead Sponsor Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Other Rate of patients with ventricular tachycardia or ventricular fibrillation events, with appropriate therapies After the device replacement and after a minimum of two years FU
Other Rate of patients with inappropriate therapies/diagnosis After the device replacement and after a minimum of two years FU
Other Baseline factor predictors of ventricular events After the device replacement and after a minimum of two years FU
Other Serious adverse events related to ventricular events / inappropriate therapies After the device replacement and after a minimum of two years FU
Primary Assess the rate of patients with at least one sustained VTA after replacement up to two years
Secondary Rate of patients with at least one VTA for 4 specific subgroups 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)
See also
  Status Clinical Trial Phase
Recruiting NCT02076789 - DEtect Long-term Complications After icD rEplacement: a Multicenter Italian Registry N/A
Completed NCT00395447 - REPLACE: Implantable Cardiac Pulse Generator Replacement Registry Phase 4