Clinical trial NCT02167789: Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
Official title: Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: HF, diagnosis
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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
* 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)

Primary outcomes:
measure: Number of HF related events
timeFrame: 13 months
Secondary outcomes:
measure: Co morbidities
timeFrame: 13 months
Other outcomes:
Locations:
city: Kaplan, Phoenix,
country: United States
facility: Dr. Haines
state: Arizona
city: Siegel, Phoenix,
country: United States
facility: Drs. Lewis, Garg
state: Arizona
city: Boston
country: United States
facility: Drs. Jagmeet Singh, Kevin, Hiest
state: Massachusetts
city: Montefiore, Bronx NY
country: United States
facility: Drs. John Fisher, Jay Gross
state: New York
city: Charleston
country: United States
facility: Dr. Gold
state: South Carolina
city: Quebec
country: Canada
facility: Dr. Champagne, Dr. Philippon
city: Quebec
country: Canada
facility: Drs. Thibualt, Guerra
city: Angers
country: France
facility: Dr. Dupuis
city: Grenoble
country: France
facility: Dr. Defaye
city: La Rochelle
country: France
facility: Dr. Bru
city: Lille
country: France
facility: Pr. Kacet
city: Marseille
country: France
facility: Dr. Pisapia
city: Montpellier
country: France
facility: Pr. Davy
city: Nantes
country: France
facility: Dr. Burban
city: Nantes
country: France
facility: Dr Abbey
city: Paris
country: France
facility: Dr. Jauvert
city: Pessac
country: France
facility: Dr. Ritter
city: Rennes
country: France
facility: Pr. Mabo
city: Rouen
country: France
facility: Pr. Anselme
city: Saint Etienne
country: France
facility: Pr. Da Costa
city: Toulouse
country: France
facility: Dr. Delay
city: Vandoeuvre Les Nancy
country: France
facility: Pr. Sadoul
city: Bad Nauheim
country: Germany
facility: Dr. Sperzel
city: Bad Oeynhausen
country: Germany
facility: Dr. Vogt
city: Berlin
country: Germany
facility: Dr. Fleck - Dr. Goetze
city: Berlin
country: Germany
facility: Dr. Schlegl
city: Bernau
country: Germany
facility: Dr. Butter
city: Coburg
country: Germany
facility: Pr. Brachmann
city: Hannover
country: Germany
facility: Dr. Klein - Dr. Oswald
city: Heidelberg
country: Germany
facility: Pr. Bauer
city: Homburg
country: Germany
facility: Pr. Mewis - Pr. Fröhlig
city: Kiel
country: Germany
facility: Dr. Wieckhorst
city: Lübeck
country: Germany
facility: Dr. Bonnemeier
city: Lüneburg
country: Germany
facility: Pr. Weiss
city: Munchen
country: Germany
facility: Dr. Kolb
city: Münster
country: Germany
facility: Pr. Eckhardt
city: Roma
country: Italy
facility: Dr. Leonardo Calo
city: Treviso
country: Italy
facility: Dr Mantovan
city: Zwolle
country: Netherlands
facility: Dr. Delnoy
city: Alicante
country: Spain
facility: Dr. Martinez
city: Barcelona
country: Spain
facility: Dr. Brugada
city: Madrid
country: Spain
facility: Dr. Peinado
city: Vigo
country: Spain
facility: Dr. Beiras
city: Lugano
country: Switzerland
facility: Dr Auricchio
city: Birmingham
country: United Kingdom
facility: Dr. Leyva
city: Chertsey
country: United Kingdom
facility: Dr Fluck - Dr. Beeton
city: Leicester
country: United Kingdom
facility: Dr. NG
city: London
country: United Kingdom
facility: Dr. Murgatroyd
city: Sheffield
country: United Kingdom
facility: Dr. Bowes
city: Southampton
country: United Kingdom
facility: Dr. Morgan
Study officials:
References: