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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sorin Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01170624
First received: June 16, 2010
Last updated: July 26, 2010
Last verified: July 2010
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Sorin Group:

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

Estimated Enrollment: 558
Study Start Date: September 2009
Estimated Study Completion Date: September 2011
Estimated 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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 ClinicalTrials.gov identifier: NCT01170624

Contacts
Contact: Martino Maria +39 0161487826 Maria.Martino@sorin.com

Locations
Belgium
Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen Recruiting
Antwerpen, Belgium, 2020
Principal Investigator: DICK STOCKMAN, MD         
France
Centre Hospitalier Général Recruiting
Albi Cedex 9, France, 81013
Principal Investigator: GALLEY, MD         
Centre Hospitalier Universitaire D'Amiens Recruiting
Amiens, France, 80090
Principal Investigator: HERMIDA, MD         
Chu Annecy Recruiting
Annecy, France, 74011
Principal Investigator: DOMPNIER, MD         
CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON Recruiting
Avignon, France, 84000
Principal Investigator: Jean-Paul FAUGIER, MD         
Hopital D'Instruction Des Armees Recruiting
Clamart, France, 92141
Principal Investigator: LERECOUVREUX, MD         
Hôpital St Joseph Recruiting
Lyon, France, 69000
Principal Investigator: LOPEZ, MD         
Centre Hospitalier Universitaire de La Timone Recruiting
Marseille, France, 13000
Principal Investigator: FAUGERE, MD         
Hopital Le Raincy Montfermeil Recruiting
Montfermeil, France, 93370
Principal Investigator: AMARA, MD         
HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie Recruiting
Montpellier Cedex 5, France, 34295
Principal Investigator: PASQUIE, MD         
Hopital de La Source Recruiting
Orleans, France, 45067
Principal Investigator: BIZEAU, MD         
Centre Hospitalier Recruiting
PAU, France, 64000
Principal Investigator: DELARCHE, MD         
CLINIQUE ST PIERRE Cardiologie Recruiting
Perpignan, France, 66000
Principal Investigator: Henri BENKEMOUN, MD         
Ccn: Centre Cardiologique Du Nord St Denis Recruiting
St Denis, France, 93000
Principal Investigator: PIOT, MD         
Chru Hôpital Trousseau Recruiting
Tours, France, 37000
Principal Investigator: RIOUX, MD         
Germany
Kerckhoff Klinik Cardiology Department Recruiting
Bad Nauheim, Germany, 61231
Contact: Martino Maria    +39 0161487826    Maria.Martino@sorin.com   
Principal Investigator: SPERZEL Johannes         
Lerckhoff Klinik Recruiting
Bad Neuheim, Germany, 61231
Principal Investigator: SPERZEL, MD         
Praxis Westend Studien GbR, Medianzentrum Haus 9 Recruiting
Berlin, Germany, 14050
Principal Investigator: SCHLEGL, MD         
Klinik Frankische Schweiz Recruiting
Ebermannstadt, Germany, 91316 - 91320
Principal Investigator: SCHIBGILLA VOLKER, MD         
Med. Univ. Klinik Lübeck Recruiting
Lübeck, Germany, 23501 − 23570
Principal Investigator: POTRATZ, MD         
Italy
Spedali Civili Divisione di Cardiologia Recruiting
Brescia, Italy, 25123
Principal Investigator: Antonio CURNIS, md         
Azienda Ospedaliera S. Croce E Carle Recruiting
Cuneo, Italy, 12100
Principal Investigator: ROSSETTI, MD         
Portugal
Hospital de Santa Cruz - Carnaxide (Adragão) Recruiting
Carnaxide, Lisbon, Portugal, 2795
Principal Investigator: ADRAGÃO, MD         
Hospital Garcia de Orta Recruiting
Almada, Portugal, 2801-951
Principal Investigator: BRANDÃO, MD         
Hospital Central Faro Recruiting
Faro, Portugal, 8000
Principal Investigator: JESUS, MD         
Sponsors and Collaborators
Sorin Group
  More Information

No publications provided

Responsible Party: Clinical Status Monitoring in ICD Patients by PhD functions, Sorin Group
ClinicalTrials.gov Identifier: NCT01170624     History of Changes
Other Study ID Numbers: TUTOR - ITSY04
Study First Received: June 16, 2010
Last Updated: July 26, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Sorin Group:
PhD
EGM
CRT-D
The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014