Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
CLEPSYDRA
1 other identifier
interventional
520
9 countries
50
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 heart-failure
Started Sep 2009
Typical duration for phase_3 heart-failure
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 19, 2014
CompletedJune 19, 2014
June 1, 2014
3.8 years
June 17, 2014
June 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of HF related events
13 months
Secondary Outcomes (1)
Co morbidities
13 months
Study Arms (1)
PhD
NO INTERVENTIONInterventions
Eligibility Criteria
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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
Study Sites (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
Québec, Quebec, G1V 4G5, Canada
Drs. Thibualt, Guerra
Québec, Quebec, H1T 1C8, Canada
Dr. Dupuis
Angers, Angers, 49033, France
Dr. Defaye
Grenoble, Grenoble, 38043, France
Dr. Bru
La Rochelle, La Rochelle, 17019, France
Pr. Kacet
Lille, Lille, 59037, France
Dr. Pisapia
Marseille, Marseille, 13008, France
Pr. Davy
Montpellier, Montpellier, 34000, France
Dr. Burban
Nantes, Nantes, 44000, France
Dr Abbey
Nantes, Nantes, 44093, France
Dr. Ritter
Pessac, Pessac, 33604, France
Pr. Mabo
Rennes, Rennes, 35033, France
Pr. Anselme
Rouen, Rouen, 76031, France
Pr. Da Costa
Saint-Etienne, Saint Etienne, 42055, France
Dr. Delay
Toulouse, Toulouse, 31059, France
Pr. Sadoul
Vandœuvre-lès-Nancy, Vandoeuvre Les Nancy, 54500, France
Dr. Jauvert
Paris, 75016, France
Dr. Sperzel
Bad Nauheim, Bad Nauheim, D-61231, Germany
Dr. Vogt
Bad Oeynhausen, Bad Oeynhausen, D-32545, Germany
Dr. Butter
Bernau, Bernau, 16321, Germany
Pr. Brachmann
Coburg, Coburg, D-48149, Germany
Dr. Klein - Dr. Oswald
Hanover, Hannover, 30625, Germany
Pr. Bauer
Heidelberg, Heidelberg, 69120, Germany
Pr. Mewis - Pr. Fröhlig
Homburg, Homburg, D-66421, Germany
Dr. Wieckhorst
Kiel, Kiel, 24105, Germany
Dr. Bonnemeier
Lübeck, Lübeck, D-23538, Germany
Pr. Weiss
Lüneburg, Lüneburg, 21339, Germany
Dr. Kolb
München, Munchen, 80636, Germany
Pr. Eckhardt
Münster, Münster, D-48149, Germany
Dr. Fleck - Dr. Goetze
Berlin, State of Berlin, 13353, Germany
Dr. Schlegl
Berlin, State of Berlin, 14050, Germany
Dr. Leonardo Calo
Roma, Roma, 00169, Italy
Dr Mantovan
Treviso, Treviso, 31100, Italy
Dr. Delnoy
Zwolle, Zwolle, 10500, Netherlands
Dr. Martinez
Alicante, Alicante, 03010, Spain
Dr. Brugada
Barcelona, Barcelona, 08036, Spain
Dr. Peinado
Madrid, Madrid, 28046, Spain
Dr. Beiras
Vigo, Vigo, 3204, Spain
Dr Auricchio
Lugano, Lugano, CH-6900, Switzerland
Dr. Leyva
Birmingham, Birmingham, B75 7RR, United Kingdom
Dr Fluck - Dr. Beeton
Chertsey, Chertsey, KT160PZ, United Kingdom
Dr. NG
Leicester, Leicester, LE3 9PQ, United Kingdom
Dr. Murgatroyd
London, London, WC2R 2LS, United Kingdom
Dr. Bowes
Sheffield, Sheffield, S5 7AU, United Kingdom
Dr. Morgan
Southampton, Southampton, SO16 9YD, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 19, 2014
Study Start
September 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 19, 2014
Record last verified: 2014-06