Clinical trial NCT04118803: Observational Study on Inappropriate Therapies
Official title: Observational Study on Inappropriate Therapies After Replacement of ICDs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inappropriate Shocks From Implanted Defibrillator
ICD Replacement or Upgrade
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2019-10-08
Enrollment: 881
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated for an ICD or CRT-D implant according to the latest applicable guidelines and requiring a device replacement or system upgrade from a previous ICD (VR/DR/CRT-D).

Brief summary: The purpose of the study is to assess the incidence of inappropriate shocks at 2 years, in a population of patients undergoing a generator replacement (VR/DR/CRT) or upgrade from a previously implanted ICD (VR/DR)

Detailed description: All subjects will be included during an inclusion visit (within 7 days post generator replacement or upgrade), and followed up at a post replacement visit (1 - 6 months post replacement or upgrade), at 12, 18 and 24 months post replacement or upgrade. These follow-up visits will be performed in-clinic except for the 18 months post replacement or upgrade visit, which could be performed through device remote monitoring.

Additional follow-ups can be performed at physician's discretion. Data on reportable adverse events will be collected throughout the study. All study data will be collected using an EDC system.

All delivered anti-tachycardia therapies (shock or ATP) will be reviewed by an independent board of experts in order to evaluate appropriateness.

The programming of the device parameters is at physician's discretion (suggested settings is slow VT monitoring zone 150 - 185 bpm with 30 cycles persistence, VT zone 185 - 230 bpm with 16 cycles persistence, remote monitoring activated).

Eligibility criteria: Inclusion Criteria:

1. Any subject that had an ICD/CRT-D replacement/upgrade according to the latest relevant clinical guidelines with a MicroPort CRM ICD / CRT-D for less than 7 days
2. Signed and dated the informed consent form

Exclusion Criteria:

1. RV lead replacement
2. Previous ICD/CRT-D inactivated or already explanted
3. Active myocarditis
4. Primary prevention for Arrhythmogenic Ventricular Cardiomyopathy, Ion channelopathies, Hypertrophic Cardiomyopathy and Infiltrative or Inherited Cardiomyopathy.
5. Heart transplant (done or on waiting list) or implanted with a ventricular assist device (VAD)
6. Already included in an Interventional study that could confound the results of this study
7. Inability to understand the purpose of the study or to meet follow-up visits as defined in the investigational plan
8. Minor age (\<18 years) or under guardianship or kept in detention
9. Ongoing drug or alcohol addiction or abuse which would interfere with the subject's ability to be compliant with the study.
10. Life expectancy less than 1 year
11. Pregnant or breast feeding

Primary outcomes:
measure: Incidence of inappropriate shocks
timeFrame: 2 years after replacement or upgrade
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medicine Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Langhorne
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck - Kardiologie und Angiologie
city: Vienna
country: Austria
facility: Akademisches Krankenhaus Wien
city: Wiener Neustadt
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Jette
country: Belgium
facility: UZ Brussel
city: Yvoir
country: Belgium
facility: UCL Mont-Godinne
city: Aix-en-Provence
country: France
facility: CH du Pays d'Aix
city: Annecy
country: France
facility: CH Annecy Genevois
city: Avignon
country: France
facility: Clinique Rhône Durance
city: Brest
country: France
facility: CHU Brest
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Grenoble
country: France
facility: CHU de Grenoble
city: Libourne
country: France
facility: CH de Libourne Robert Boulin
city: Limoges
country: France
facility: CHU Dupuytren
city: Marseille
country: France
facility: Hôpital Nord
city: Marseille
country: France
facility: Hôpital Privé Clairval
city: Montpellier
country: France
facility: Clinique du Millénaire
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU Groupe HU Caremeau
city: Perpignan
country: France
facility: CH de Perpignan CHG St Jean
city: Poitiers
country: France
facility: CHU Poitiers
city: Saint-Étienne
country: France
facility: CHU - Hôpital Nord - Saint-Étienne
city: Toulon
country: France
facility: CHI Toulon La Seyne Sur Mer
city: Toulouse
country: France
facility: Centre Hospitalier de Rangueil
city: Valence
country: France
facility: Centre Hospitalier de Valence
city: Kiel
country: Germany
facility: UKSH Schleswig Holstein Campus Kiel
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Pirna
country: Germany
facility: Cardiologicum
city: Unna
country: Germany
facility: Katharinen Hospital Unna
city: Andria
country: Italy
facility: Ospedale L. Bonomo
city: Avellino
country: Italy
facility: Azienda Ospedaliera G. Moscati
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS. Annunziata
city: Chioggia
country: Italy
facility: Presidio Ospedaliero di Chioggia
city: Conegliano
country: Italy
facility: Ospedale Santa Maria dei Battuti
city: L'Aquila
country: Italy
facility: Ospedale San Salvatore
city: Milan
country: Italy
facility: Grande Ospedale Metropolitano Niguarda Ca Granda
city: Monza
country: Italy
facility: Ospedale S. Gerardo
city: Napoli
country: Italy
facility: Ospedale Policlinico Federico II
city: Ragusa
country: Italy
facility: Ospedale Giovanni Paolo II
city: Teramo
country: Italy
facility: Ospedale Giuseppe Mazzini
city: Trieste
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Di Trieste
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Wetzikon
country: Switzerland
facility: GZO Spital Wetzikon AG
city: Belfast
country: United Kingdom
facility: Belfast Health & Social Care Trust
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS TRUST
Study officials:
affiliation: Deutsches Herzzentrum, Lazarettstraße 36, 80636 Munich, Germany
name: Christoff Kolb, Dr.
role: PRINCIPAL_INVESTIGATOR
References: