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Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function

NCT ID: NCT01170624

Last Updated: 2015-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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ICD

Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LivaNova

INDUSTRY

Sponsor Role lead

Responsible Party

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Sorin Group

Locations

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Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen

Antwerp, , Belgium

Site Status

Centre Hospitalier Général

Albi, , France

Site Status

Centre Hospitalier Universitaire D'Amiens

Amiens, , France

Site Status

Chu Annecy

Annecy, , France

Site Status

CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON

Avignon, , France

Site Status

Hopital D'Instruction Des Armees

Clamart, , France

Site Status

Hôpital St Joseph

Lyon, , France

Site Status

Centre Hospitalier Universitaire de La Timone

Marseille, , France

Site Status

Hopital Le Raincy Montfermeil

Montfermeil, , France

Site Status

HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie

Montpellier, , France

Site Status

Hopital de La Source

Orléans, , France

Site Status

Centre Hospitalier

Pau, , France

Site Status

CLINIQUE ST PIERRE Cardiologie

Perpignan, , France

Site Status

Ccn: Centre Cardiologique Du Nord St Denis

Saint-Denis, , France

Site Status

Chru Hôpital Trousseau

Tours, , France

Site Status

Kerckhoff Klinik Cardiology Department

Bad Nauheim, , Germany

Site Status

Lerckhoff Klinik

Bad Neuheim, , Germany

Site Status

Praxis Westend Studien GbR, Medianzentrum Haus 9

Berlin, , Germany

Site Status

Klinik Frankische Schweiz

Ebermannstadt, , Germany

Site Status

Med. Univ. Klinik Lübeck

Lübeck, , Germany

Site Status

Spedali Civili Divisione di Cardiologia

Brescia, , Italy

Site Status

Azienda Ospedaliera S. Croce E Carle

Cuneo, , Italy

Site Status

Hospital de Santa Cruz - Carnaxide (Adragão)

Carnaxide, Lisbon District, Portugal

Site Status

Hospital Garcia de Orta

Almada, , Portugal

Site Status

Hospital Central Faro

Faro, , Portugal

Site Status

Countries

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Belgium France Germany Italy Portugal

Other Identifiers

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TUTOR - ITSY04

Identifier Type: -

Identifier Source: org_study_id

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