Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
Completed · Phase 3
Conditions studied: Heart Failure
In brief
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).
Key facts
- Study ID
- NCT02167789
- Run by
- LivaNova
- People needed
- 520
- Starts
- 2009-09-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2014-06-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- 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
Full record on ClinicalTrials.gov
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