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

Phase 4

Terminated

• Conditions: Heart Failure

• Registration Number: NCT01170624
• Lead Sponsor: LivaNova

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-09
• Last Update Posted: 2015-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 388

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The objective is to demonstrate that agreement correlation is superior to 67%	13 months

Trial Locations

Locations (25)

Hospital de Santa Cruz - Carnaxide (Adragão); 🇵🇹 Carnaxide, Lisbon, Portugal

Med. Univ. Klinik Lübeck; 🇩🇪 Lübeck, Germany

Algemeen Ziekenhuis Middelheim Lindendref 1 2020 Antwerpen; 🇧🇪 Antwerpen, Belgium

Centre Hospitalier Général; 🇫🇷 Albi Cedex 9, France

Chu Annecy; 🇫🇷 Annecy, France

Hôpital St Joseph; 🇫🇷 Lyon, France

CLINIQUE ST PIERRE Cardiologie; 🇫🇷 Perpignan, France

HOPITAL ARNAUD DE VILLENEUVE - Service de Cardiologie; 🇫🇷 Montpellier Cedex 5, France

Hopital de La Source; 🇫🇷 Orleans, France

Chru Hôpital Trousseau; 🇫🇷 Tours, France

Klinik Frankische Schweiz; 🇩🇪 Ebermannstadt, Germany

Kerckhoff Klinik Cardiology Department; 🇩🇪 Bad Nauheim, Germany

Centre Hospitalier Universitaire D'Amiens; 🇫🇷 Amiens, France

CENTRE HOSP. HENRI DUFFAUT - Service de Cardiologie AVIGNON; 🇫🇷 Avignon, France

Centre Hospitalier; 🇫🇷 PAU, France

Azienda Ospedaliera S. Croce E Carle; 🇮🇹 Cuneo, Italy

Hospital Central Faro; 🇵🇹 Faro, Portugal

Hopital D'Instruction Des Armees; 🇫🇷 Clamart, France

Lerckhoff Klinik; 🇩🇪 Bad Neuheim, Germany

Hospital Garcia de Orta; 🇵🇹 Almada, Portugal

Centre Hospitalier Universitaire de La Timone; 🇫🇷 Marseille, France

Hopital Le Raincy Montfermeil; 🇫🇷 Montfermeil, France

Ccn: Centre Cardiologique Du Nord St Denis; 🇫🇷 St Denis, France

Spedali Civili Divisione di Cardiologia; 🇮🇹 Brescia, Italy

Praxis Westend Studien GbR, Medianzentrum Haus 9; 🇩🇪 Berlin, Germany