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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170624

Acronym

TUTOR

Enrollment

388

Registered

2010-07-27

Start date

2009-09-30

Completion date

2011-09-30

Last updated

2015-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

PhD, EGM, CRT-D, The study will particularly focus on a new-based diagnostic feature, called PhD-Clinical Status (PhD)

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.

Interventions

DEVICEICD

Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
The objective is to demonstrate that agreement correlation is superior to 67%	13 months

Countries

Belgium, France, Germany, Italy, Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026