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

Primary Purpose

Heart Failure

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ICD
Sponsored by
LivaNova
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring PhD, EGM, CRT-D, The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen
  • Centre Hospitalier Général
  • Centre Hospitalier Universitaire D'Amiens
  • Chu Annecy
  • CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON
  • Hopital D'Instruction Des Armees
  • Hôpital St Joseph
  • Centre Hospitalier Universitaire de La Timone
  • Hopital Le Raincy Montfermeil
  • HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie
  • Hopital de La Source
  • Centre Hospitalier
  • CLINIQUE ST PIERRE Cardiologie
  • Ccn: Centre Cardiologique Du Nord St Denis
  • Chru Hôpital Trousseau
  • Kerckhoff Klinik Cardiology Department
  • Lerckhoff Klinik
  • Praxis Westend Studien GbR, Medianzentrum Haus 9
  • Klinik Frankische Schweiz
  • Med. Univ. Klinik Lübeck
  • Spedali Civili Divisione di Cardiologia
  • Azienda Ospedaliera S. Croce E Carle
  • Hospital de Santa Cruz - Carnaxide (Adragão)
  • Hospital Garcia de Orta
  • Hospital Central Faro

Outcomes

Primary Outcome Measures

The objective is to demonstrate that agreement correlation is superior to 67%

Secondary Outcome Measures

Full Information

First Posted
June 16, 2010
Last Updated
January 9, 2015
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT01170624
Brief Title
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) Function
Acronym
TUTOR
Official Title
Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Field Safety Notice related to potential ventricular oversensing associated to the PhD feature on Paradym ICDs
Study Start Date
September 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
LivaNova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
PhD, EGM, CRT-D, The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ICD
Intervention Description
Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250
Primary Outcome Measure Information:
Title
The objective is to demonstrate that agreement correlation is superior to 67%
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient eligible for implantation of an ICD or a CRT-D device according to current available guidelines. Documented chronic HF (NYHA Class II to IV) at the time of enrollment Scheduled for implant of a PARADYM ICD / CRT-D or implanted within the previous month Signed and dated informed consent Exclusion Criteria: Any contraindication for ICD therapy Abdominal implantation site Acute myocarditis Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month Planned heart transplant Mechanical tricuspid valve Unable to perform the 6 minute Walking Test at time of enrollment Already included in another clinical study Life expectancy less than 13 months Inability to understand the purpose of the study or refusal to cooperate Inability or refusal to provide informed consent Under guardianship Age of less than 18 years Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
Facility Information:
Facility Name
Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Centre Hospitalier Général
City
Albi Cedex 9
ZIP/Postal Code
81013
Country
France
Facility Name
Centre Hospitalier Universitaire D'Amiens
City
Amiens
ZIP/Postal Code
80090
Country
France
Facility Name
Chu Annecy
City
Annecy
ZIP/Postal Code
74011
Country
France
Facility Name
CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Hopital D'Instruction Des Armees
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Hôpital St Joseph
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Centre Hospitalier Universitaire de La Timone
City
Marseille
ZIP/Postal Code
13000
Country
France
Facility Name
Hopital Le Raincy Montfermeil
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital de La Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Centre Hospitalier
City
PAU
ZIP/Postal Code
64000
Country
France
Facility Name
CLINIQUE ST PIERRE Cardiologie
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Ccn: Centre Cardiologique Du Nord St Denis
City
St Denis
ZIP/Postal Code
93000
Country
France
Facility Name
Chru Hôpital Trousseau
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Kerckhoff Klinik Cardiology Department
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Lerckhoff Klinik
City
Bad Neuheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Praxis Westend Studien GbR, Medianzentrum Haus 9
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Klinik Frankische Schweiz
City
Ebermannstadt
ZIP/Postal Code
91316 - 91320
Country
Germany
Facility Name
Med. Univ. Klinik Lübeck
City
Lübeck
ZIP/Postal Code
23501 - 23570
Country
Germany
Facility Name
Spedali Civili Divisione di Cardiologia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce E Carle
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
Facility Name
Hospital de Santa Cruz - Carnaxide (Adragão)
City
Carnaxide
State/Province
Lisbon
ZIP/Postal Code
2795
Country
Portugal
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Hospital Central Faro
City
Faro
ZIP/Postal Code
8000
Country
Portugal

12. IPD Sharing Statement

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

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