Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
NCT ID: NCT02167789
Last Updated: 2014-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
520 participants
INTERVENTIONAL
2009-09-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PhD
Paradym CRT 8770
Interventions
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Paradym CRT 8770
Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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Locations
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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
Québec, Quebec, Canada
Drs. Thibualt, Guerra
Québec, Quebec, Canada
Dr. Dupuis
Angers, Angers, France
Dr. Defaye
Grenoble, Grenoble, France
Dr. Bru
La Rochelle, La Rochelle, France
Pr. Kacet
Lille, Lille, France
Dr. Pisapia
Marseille, Marseille, France
Pr. Davy
Montpellier, Montpellier, France
Dr. Burban
Nantes, Nantes, France
Dr Abbey
Nantes, Nantes, France
Dr. Ritter
Pessac, Pessac, France
Pr. Mabo
Rennes, Rennes, France
Pr. Anselme
Rouen, Rouen, France
Pr. Da Costa
Saint-Etienne, Saint Etienne, France
Dr. Delay
Toulouse, Toulouse, France
Pr. Sadoul
Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy, France
Dr. Jauvert
Paris, , France
Dr. Sperzel
Bad Nauheim, Bad Nauheim, Germany
Dr. Vogt
Bad Oeynhausen, Bad Oeynhausen, Germany
Dr. Butter
Bernau, Bernau, Germany
Pr. Brachmann
Coburg, Coburg, Germany
Dr. Klein - Dr. Oswald
Hanover, Hannover, Germany
Pr. Bauer
Heidelberg, Heidelberg, Germany
Pr. Mewis - Pr. Fröhlig
Homburg, Homburg, Germany
Dr. Wieckhorst
Kiel, Kiel, Germany
Dr. Bonnemeier
Lübeck, Lübeck, Germany
Pr. Weiss
Lüneburg, Lüneburg, Germany
Dr. Kolb
München, Munchen, Germany
Pr. Eckhardt
Münster, Münster, Germany
Dr. Fleck - Dr. Goetze
Berlin, State of Berlin, Germany
Dr. Schlegl
Berlin, State of Berlin, Germany
Dr. Leonardo Calo
Roma, Roma, Italy
Dr Mantovan
Treviso, Treviso, Italy
Dr. Delnoy
Zwolle, Zwolle, Netherlands
Dr. Martinez
Alicante, Alicante, Spain
Dr. Brugada
Barcelona, Barcelona, Spain
Dr. Peinado
Madrid, Madrid, Spain
Dr. Beiras
Vigo, Vigo, Spain
Dr Auricchio
Lugano, Lugano, Switzerland
Dr. Leyva
Birmingham, Birmingham, United Kingdom
Dr Fluck - Dr. Beeton
Chertsey, Chertsey, United Kingdom
Dr. NG
Leicester, Leicester, United Kingdom
Dr. Murgatroyd
London, London, United Kingdom
Dr. Bowes
Sheffield, Sheffield, United Kingdom
Dr. Morgan
Southampton, Southampton, United Kingdom
Countries
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Other Identifiers
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ITSY02
Identifier Type: -
Identifier Source: org_study_id
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