Clinical trial NCT01170624: Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function
Official title: Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Failure
Keywords: PhD
EGM
CRT-D
The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2010-07-27
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the performance of advanced features, that have been implemented in the PARADYM ICD Platform offering single chamber (VR - model 8250), dual Chamber (DR - 8550) and Cardiac Resynchronization System with defibrillation capabilities (PARADYM CRT System, model 8750) in a general ICD population.

Detailed description: The study will particularly focus on a new sensor-based diagnostic feature, called PhD-Clinical Status (PhD). A dedicated PhD screen shows the trends of patients' ventilation levels at rest (MVR) and under effort (MVE), and the corresponding level of activity, day-by-day, over a period of 6 months.

Eligibility criteria: Inclusion Criteria:

1. Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines.
2. Documented chronic HF (NYHA Class II to IV) at the time of enrollment
3. Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month
4. Signed and dated informed consent

Exclusion Criteria:

1. Any contraindication for ICD therapy
2. Abdominal implantation site
3. Acute myocarditis
4. Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
5. Planned heart transplant
6. Mechanical tricuspid valve
7. Unable to perform the 6 minute Walking Test at time of enrollment
8. Already included in another clinical study
9. Life expectancy less than 13 months
10. Inability to understand the purpose of the study or refusal to cooperate
11. Inability or refusal to provide informed consent
12. Under guardianship
13. Age of less than 18 years
14. Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)

Primary outcomes:
measure: The objective is to demonstrate that agreement correlation is superior to 67%
timeFrame: 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen
city: Albi Cedex 9
country: France
facility: Centre Hospitalier Général
city: Amiens
country: France
facility: Centre Hospitalier Universitaire D'Amiens
city: Annecy
country: France
facility: Chu Annecy
city: Avignon
country: France
facility: CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON
city: Clamart
country: France
facility: Hopital D'Instruction Des Armees
city: Lyon
country: France
facility: Hôpital St Joseph
city: Marseille
country: France
facility: Centre Hospitalier Universitaire de La Timone
city: Montfermeil
country: France
facility: Hopital Le Raincy Montfermeil
city: Montpellier Cedex 5
country: France
facility: HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie
city: Orleans
country: France
facility: Hopital de La Source
city: PAU
country: France
facility: Centre Hospitalier
city: Perpignan
country: France
facility: CLINIQUE ST PIERRE Cardiologie
city: St Denis
country: France
facility: Ccn: Centre Cardiologique Du Nord St Denis
city: Tours
country: France
facility: Chru Hôpital Trousseau
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik Cardiology Department
city: Bad Neuheim
country: Germany
facility: Lerckhoff Klinik
city: Berlin
country: Germany
facility: Praxis Westend Studien GbR, Medianzentrum Haus 9
city: Ebermannstadt
country: Germany
facility: Klinik Frankische Schweiz
city: Lübeck
country: Germany
facility: Med. Univ. Klinik Lübeck
city: Brescia
country: Italy
facility: Spedali Civili Divisione di Cardiologia
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce E Carle
city: Carnaxide
country: Portugal
facility: Hospital de Santa Cruz - Carnaxide (Adragão)
state: Lisbon
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Faro
country: Portugal
facility: Hospital Central Faro
Study officials:
References: