Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device

Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02167789

Acronym

CLEPSYDRA

Enrollment

520

Registered

2014-06-19

Start date

2009-09-30

Completion date

2013-06-30

Last updated

2014-06-19

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

Conditions

Heart Failure

Keywords

HF, diagnosis

Brief summary

This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature Physiological Diagnostic (PhD).

Detailed description

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.

Interventions

DEVICEParadym CRT 8770

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy * Severe HF (NYHA Class III or IV) at the time of enrollment * At least one HF-related event (as defined for primary objective) within the last 6 months before enrolment * Subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure * Scheduled for implant of a PARADYM 8770 * Signed and dated informed consent

Exclusion criteria

* Any contraindication for standard cardiac pacing * Any contraindication for ICD therapy * Abdominal implantation side * Hypertrophic or obstructive cardiomyopathy * Acute myocarditis * Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month * Recent (within the last month) or planned cardiac revascularization or coronary angioplasty * Correctable valvular disease that is the primary cause of heart failure * Mechanical tricuspid valve * Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week * Heart transplant recipient * Renal insufficiency requiring dialysis * Already included in another clinical study * Life expectancy less than 12 months * Inability to understand the purpose of the study or refusal to cooperate * Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization * Unavailability for scheduled follow-up at the implanting center * Known sensitivity to 1 mg dexamethasone sodium phosphate (DSP) * Under guardianship * Age of less than 18 years * Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)

Design outcomes

Primary

Measure	Time frame
Number of HF related events	13 months

Secondary

Measure	Time frame
Co morbidities	13 months

Countries

Canada, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States

Outcome results

None listed

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