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

NCT02323503 | Completed DMC

• 1 other identifier: CR018
• Study Type: observational
• Target: 289
• Locations: 8 countries
• Sites: 37

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.

Conditions

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

Keywords

CRT-D; replacement; primary prevention; ventricular tachyarrhythmias

Outcome Measures

Primary Outcomes (1)

• Assess the rate of patients with at least one sustained VTA after replacement

  up to two years

Secondary Outcomes (1)

• 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)

Other Outcomes (4)

• 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

• Rate of patients with inappropriate therapies/diagnosis

  After the device replacement and after a minimum of two years FU

• Baseline factor predictors of ventricular events

  After the device replacement and after a minimum of two years FU

Interventions

CRT-D device replacement DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Sites (37)

OLV Aalst

Aalst, Belgium

Location

CH d'Annecy

Annecy, France

Location

Hôpital de la Cavale Blanche

Brest, France

Location

CHU Caen

Caen, France

Location

CHU Montpied

Clermont-Ferrand, France

Location

CH Du Bocage

Dijon, France

Location

CHRU de Lille

Lille, France

Location

CHU de Limoges

Limoges, France

Location

CH Saint Philibert

Lomme, France

Location

Cliniques du Tonkin, de la Sauvegarde et Protestante

Lyon, France

Location

Clinique Clairval

Marseille, France

Location

Hôpital de la Timone

Marseille, France

Location

Hôpital Mercy

Metz, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nancy

Nancy, France

Location

Nouvelles Cliniques Nantaises

Nantes, France

Location

CH de la Pitié Salpétrière

Paris, France

Location

CHU Pessac

Pessac, France

Location

CHU de Rennes

Rennes, France

Location

CHU Hôpital CHarles Nicolle

Rouen, France

Location

CH de Saint-Etienne

Saint-Etienne, France

Location

CHU Toulouse

Toulouse, 31403, France

Location

CHU Tours

Tours, France

Location

Schuechtermann-Klinik

Bad Rothenfelde, Germany

Location

Stadtisches Klinikum Brandenburg

Brandenburg, Germany

Location

DRK-Krankenhaus Moelln Ratzeburg

Ratzeburg, Germany

Location

Cardiological Praxis

Rostock, Germany

Location

Semmelweis University

Budapest, Hungary

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Ospedale Versilia

Lido di Camaiore, Italy

Location

Clinica Mediterranea

Napoli, Italy

Location

Ospedale Santa Chiara

Pisa, Italy

Location

Hospital de Santa Maria

Lisbon, Portugal

Location

Hospital de Santa Marta

Lisbon, Portugal

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Location

Related Publications (1)

• 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.

  PMID: 36459310 DERIVED

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel DG Gras, MD

  Nouvelles Cliniques Nantaises, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: June 9, 2015
• Primary Completion: February 12, 2020
• Study Completion: February 12, 2020
• Last Updated: March 31, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); HU (1); BE (1); IL (1); IT (3); FR (22); ES (3); PT (2)