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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
520

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: PhD
Device: Paradym CRT 8770

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of HF related events
Time Frame: 13 months
13 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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