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Clinical Trials/NCT02167789
NCT02167789CompletedPhase 3

Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

LivaNova95 sites in 9 countries520 target enrollmentStarted: September 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
LivaNova
Enrollment
520
Locations
95
Primary Endpoint
Number of HF related events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Number of HF related events

Time Frame: 13 months

Secondary Outcomes

  • Co morbidities(13 months)

Investigators

Sponsor
LivaNova
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (95)

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