Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device (CLEPSYDRA)

June 17, 2014 updated by: LivaNova

Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Dr. Champagne, Dr. Philippon
      • Quebec, Canada, H1T 1C8
        • Drs. Thibualt, Guerra
  • France
      • Angers, France, 49033
        • Dr. Dupuis
      • Grenoble, France, 38043
        • Dr. Defaye
      • La Rochelle, France, 17019
        • Dr. Bru
      • Lille, France, 59037
        • Pr. Kacet
      • Marseille, France, 13008
        • Dr. Pisapia
      • Montpellier, France, 34000
        • Pr. Davy
      • Nantes, France, 44000
        • Dr. Burban
      • Nantes, France, 44093
        • Dr Abbey
      • Paris, France, 75016
        • Dr. Jauvert
      • Pessac, France, 33604
        • Dr. Ritter
      • Rennes, France, 35033
        • Pr. Mabo
      • Rouen, France, 76031
        • Pr. Anselme
      • Saint Etienne, France, 42055
        • Pr. Da Costa
      • Toulouse, France, 31059
        • Dr. Delay
      • Vandoeuvre Les Nancy, France, 54500
        • Pr. Sadoul
  • Germany
      • Bad Nauheim, Germany, D-61231
        • Dr. Sperzel
      • Bad Oeynhausen, Germany, D-32545
        • Dr. Vogt
      • Berlin, Germany, 13353
        • Dr. Fleck - Dr. Goetze
      • Berlin, Germany, 14050
        • Dr. Schlegl
      • Bernau, Germany, 16321
        • Dr. Butter
      • Coburg, Germany, D-48149
        • Pr. Brachmann
      • Hannover, Germany, 30625
        • Dr. Klein - Dr. Oswald
      • Heidelberg, Germany, 69120
        • Pr. Bauer
      • Homburg, Germany, D-66421
        • Pr. Mewis - Pr. Fröhlig
      • Kiel, Germany, 24105
        • Dr. Wieckhorst
      • Lübeck, Germany, D-23538
        • Dr. Bonnemeier
      • Lüneburg, Germany, 21339
        • Pr. Weiss
      • Munchen, Germany, 80636
        • Dr. Kolb
      • Münster, Germany, D-48149
        • Pr. Eckhardt
  • Italy
      • Roma, Italy, 00169
        • Dr. Leonardo Calo
      • Treviso, Italy, 31100
        • Dr Mantovan
  • Netherlands
      • Zwolle, Netherlands, 10500
        • Dr. Delnoy
  • Spain
      • Alicante, Spain, 03010
        • Dr. Martinez
      • Barcelona, Spain, 08036
        • Dr. Brugada
      • Madrid, Spain, 28046
        • Dr. Peinado
      • Vigo, Spain, 3204
        • Dr. Beiras
  • Switzerland
      • Lugano, Switzerland, CH-6900
        • Dr Auricchio
  • United Kingdom
      • Birmingham, United Kingdom, B75 7RR
        • Dr. Leyva
      • Chertsey, United Kingdom, KT160PZ
        • Dr Fluck - Dr. Beeton
      • Leicester, United Kingdom, LE3 9PQ
        • Dr. NG
      • London, United Kingdom, WC2R 2LS
        • Dr. Murgatroyd
      • Sheffield, United Kingdom, S5 7AU
        • Dr. Bowes
      • Southampton, United Kingdom, SO16 9YD
        • Dr. Morgan
  • United States
    • Arizona
      • Kaplan, Phoenix,, Arizona, United States
        • Dr. Haines
      • Siegel, Phoenix,, Arizona, United States
        • Drs. Lewis, Garg
    • Massachusetts
      • Boston, Massachusetts, United States
        • Drs. Jagmeet Singh, Kevin, Hiest
    • New York
      • Montefiore, Bronx NY, New York, United States
        • Drs. John Fisher, Jay Gross
    • South Carolina
      • Charleston, South Carolina, United States
        • Dr. Gold

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: PhD
Device: Paradym CRT 8770

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of HF related events
Time Frame: 13 months
13 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Co morbidities
Time Frame: 13 months
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LivaNova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (ESTIMATE)

June 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITSY02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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