Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
- Conditions
- Heart Failure
- Interventions
- Device: Paradym CRT 8770
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
- 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
- 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
- Arm && Interventions
Group Intervention Description PhD Paradym CRT 8770 -
- 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)
Drs. Lewis, Garg
🇺🇸Siegel, Phoenix,, Arizona, United States
Drs. John Fisher, Jay Gross
🇺🇸Montefiore, Bronx NY, New York, United States
Pr. Da Costa
🇫🇷Saint Etienne, France
Dr. Dupuis
🇫🇷Angers, France
Dr. Defaye
🇫🇷Grenoble, France
Pr. Anselme
🇫🇷Rouen, France
Dr. Morgan
🇬🇧Southampton, United Kingdom
Dr. Bonnemeier
🇩🇪Lübeck, Germany
Dr. Jauvert
🇫🇷Paris, France
Dr. Haines
🇺🇸Kaplan, Phoenix,, Arizona, United States
Drs. Jagmeet Singh, Kevin, Hiest
🇺🇸Boston, Massachusetts, United States
Dr. Gold
🇺🇸Charleston, South Carolina, United States
Drs. Thibualt, Guerra
🇨🇦Quebec, Canada
Dr. Champagne, Dr. Philippon
🇨🇦Quebec, Canada
Dr. Bru
🇫🇷La Rochelle, France
Pr. Kacet
🇫🇷Lille, France
Dr. Pisapia
🇫🇷Marseille, France
Pr. Davy
🇫🇷Montpellier, France
Dr. Burban
🇫🇷Nantes, France
Dr Abbey
🇫🇷Nantes, France
Dr. Ritter
🇫🇷Pessac, France
Pr. Mabo
🇫🇷Rennes, France
Dr. Delay
🇫🇷Toulouse, France
Pr. Sadoul
🇫🇷Vandoeuvre Les Nancy, France
Dr. Sperzel
🇩🇪Bad Nauheim, Germany
Dr. Fleck - Dr. Goetze
🇩🇪Berlin, Germany
Dr. Butter
🇩🇪Bernau, Germany
Pr. Brachmann
🇩🇪Coburg, Germany
Dr. Klein - Dr. Oswald
🇩🇪Hannover, Germany
Pr. Mewis - Pr. Fröhlig
🇩🇪Homburg, Germany
Pr. Bauer
🇩🇪Heidelberg, Germany
Dr. Wieckhorst
🇩🇪Kiel, Germany
Pr. Weiss
🇩🇪Lüneburg, Germany
Pr. Eckhardt
🇩🇪Münster, Germany
Dr. Martinez
🇪🇸Alicante, Spain
Dr Mantovan
🇮🇹Treviso, Italy
Dr. Kolb
🇩🇪Munchen, Germany
Dr. Leonardo Calo
🇮🇹Roma, Italy
Dr. Delnoy
🇳🇱Zwolle, Netherlands
Dr. Beiras
🇪🇸Vigo, Spain
Dr. Brugada
🇪🇸Barcelona, Spain
Dr. Peinado
🇪🇸Madrid, Spain
Dr Auricchio
🇨🇭Lugano, Switzerland
Dr. Leyva
🇬🇧Birmingham, United Kingdom
Dr Fluck - Dr. Beeton
🇬🇧Chertsey, United Kingdom
Dr. NG
🇬🇧Leicester, United Kingdom
Dr. Murgatroyd
🇬🇧London, United Kingdom
Dr. Bowes
🇬🇧Sheffield, United Kingdom
Dr. Vogt
🇩🇪Bad Oeynhausen, Germany
Dr. Schlegl
🇩🇪Berlin, Germany