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

Heart Failure Clinical Trial

— TUTOR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01170624
• Other study ID #: TUTOR - ITSY04
• Status: Terminated
• Phase: Phase 4
• First received: June 16, 2010
• Last updated: January 9, 2015
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: January 2015
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 388
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• ICD
Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen	Antwerpen
France	Centre Hospitalier Général	Albi Cedex 9
France	Centre Hospitalier Universitaire D'Amiens	Amiens
France	Chu Annecy	Annecy
France	CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON	Avignon
France	Hopital D'Instruction Des Armees	Clamart
France	Hôpital St Joseph	Lyon
France	Centre Hospitalier Universitaire de La Timone	Marseille
France	Hopital Le Raincy Montfermeil	Montfermeil
France	HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie	Montpellier Cedex 5
France	Hopital de La Source	Orleans
France	Centre Hospitalier	PAU
France	CLINIQUE ST PIERRE Cardiologie	Perpignan
France	Ccn: Centre Cardiologique Du Nord St Denis	St Denis
France	Chru Hôpital Trousseau	Tours
Germany	Kerckhoff Klinik Cardiology Department	Bad Nauheim
Germany	Lerckhoff Klinik	Bad Neuheim
Germany	Praxis Westend Studien GbR, Medianzentrum Haus 9	Berlin
Germany	Klinik Frankische Schweiz	Ebermannstadt
Germany	Med. Univ. Klinik Lübeck	Lübeck
Italy	Spedali Civili Divisione di Cardiologia	Brescia
Italy	Azienda Ospedaliera S. Croce E Carle	Cuneo
Portugal	Hospital Garcia de Orta	Almada
Portugal	Hospital de Santa Cruz - Carnaxide (Adragão)	Carnaxide	Lisbon
Portugal	Hospital Central Faro	Faro

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The objective is to demonstrate that agreement correlation is superior to 67%		13 months	No