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

This study has been terminated.
(Field Safety Notice related to potential ventricular oversensing associated to the PhD feature on Paradym ICDs)
Information provided by:
LivaNova Identifier:
First received: June 16, 2010
Last updated: January 9, 2015
Last verified: January 2015
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.

Condition Intervention Phase
Heart Failure
Device: ICD
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Status Monitoring in ICD Patients by Physiological Diagnosis (PhD) Function

Further study details as provided by LivaNova:

Primary Outcome Measures:
  • The objective is to demonstrate that agreement correlation is superior to 67% [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment: 388
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ICD
    Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01170624

Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen
Antwerpen, Belgium, 2020
Centre Hospitalier Général
Albi Cedex 9, France, 81013
Centre Hospitalier Universitaire D'Amiens
Amiens, France, 80090
Chu Annecy
Annecy, France, 74011
Avignon, France, 84000
Hopital D'Instruction Des Armees
Clamart, France, 92141
Hôpital St Joseph
Lyon, France, 69000
Centre Hospitalier Universitaire de La Timone
Marseille, France, 13000
Hopital Le Raincy Montfermeil
Montfermeil, France, 93370
Montpellier Cedex 5, France, 34295
Hopital de La Source
Orleans, France, 45067
Centre Hospitalier
PAU, France, 64000
Perpignan, France, 66000
Ccn: Centre Cardiologique Du Nord St Denis
St Denis, France, 93000
Chru Hôpital Trousseau
Tours, France, 37000
Kerckhoff Klinik Cardiology Department
Bad Nauheim, Germany, 61231
Lerckhoff Klinik
Bad Neuheim, Germany, 61231
Praxis Westend Studien GbR, Medianzentrum Haus 9
Berlin, Germany, 14050
Klinik Frankische Schweiz
Ebermannstadt, Germany, 91316 - 91320
Med. Univ. Klinik Lübeck
Lübeck, Germany, 23501 − 23570
Spedali Civili Divisione di Cardiologia
Brescia, Italy, 25123
Azienda Ospedaliera S. Croce E Carle
Cuneo, Italy, 12100
Hospital de Santa Cruz - Carnaxide (Adragão)
Carnaxide, Lisbon, Portugal, 2795
Hospital Garcia de Orta
Almada, Portugal, 2801-951
Hospital Central Faro
Faro, Portugal, 8000
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Clinical Status Monitoring in ICD Patients by PhD functions, Sorin Group Identifier: NCT01170624     History of Changes
Other Study ID Numbers: TUTOR - ITSY04
Study First Received: June 16, 2010
Last Updated: January 9, 2015
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by LivaNova:
The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD) processed this record on November 25, 2015