Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device (CLEPSYDRA)

LivaNova

Status and phase: Completed; Phase 3

Conditions: Heart Failure

Treatments: Device: Paradym CRT 8770

Study type: Interventional

Funder types: Industry

Identifiers

NCT02167789

ITSY02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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520 participants in 1 patient group

PhD

No Intervention group

Treatment:

Device: Paradym CRT 8770