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
Recruitment status was Recruiting
Sponsor:
Sorin Group
Information provided by:
Sorin Group
ClinicalTrials.gov Identifier:
NCT01170624
First received: June 16, 2010
Last updated: July 26, 2010
Last verified: July 2010
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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:
Detailed Description:
-
Device: ICD
Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250
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:
- 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)
Contacts and Locations
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 May 19, 2013