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

Phase 3

Completed

• Conditions: Heart Failure

• Registration Number: NCT02167789
• Lead Sponsor: LivaNova

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 Timeline

• Study Start: 2009-09
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-06
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-17
• Last Update Submitted: 2014-06-17
• Study First Posted: 2014-06-19
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of HF related events	13 months

Secondary Outcome Measures

Name	Time	Method
Co morbidities	13 months

Trial Locations

Locations (50)

Dr. Haines; 🇺🇸 Kaplan, Phoenix,, Arizona, United States

Drs. Lewis, Garg; 🇺🇸 Siegel, Phoenix,, Arizona, United States

Drs. Jagmeet Singh, Kevin, Hiest; 🇺🇸 Boston, Massachusetts, United States

Drs. John Fisher, Jay Gross; 🇺🇸 Montefiore, Bronx NY, New York, United States

Dr. Gold; 🇺🇸 Charleston, South Carolina, United States

Dr. Champagne, Dr. Philippon; 🇨🇦 Quebec, Canada

Drs. Thibualt, Guerra; 🇨🇦 Quebec, Canada

Dr. Dupuis; 🇫🇷 Angers, France

Dr. Defaye; 🇫🇷 Grenoble, France

Dr. Bru; 🇫🇷 La Rochelle, France

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