Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

LivaNova50 sites in 9 countries520 target enrollmentSeptember 2009

ConditionsHeart Failure

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Heart Failure
Sponsor: LivaNova
Enrollment: 520
Locations: 50
Primary Endpoint: Number of HF related events
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

June 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

LivaNova

Responsible Party

Sponsor

Eligibility Criteria

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