Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device (CLEPSYDRA)

May 14, 2014 updated by: ELA Medical, Inc.

Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients.

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, which has been implemented in a cardiac resynchronization therapy (CRT) device. This trial will study the effectiveness of the diagnostic feature to detect heart failure events in medically stable, ICD-indicated, congestive heart failure patients. The ability of the diagnostic feature to 'detect' and 'predict' heart failure events will be studied.

Study Type

Interventional

Enrollment (Actual)

520

Phase

  • Phase 2

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

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85209
        • Mountain Vista Hospital

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:

  • Subject eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
  • Subject has severe heart failure (NYHA Class III or IV)
  • Subject has experienced at least one heart failure event within six months prior to enrollment
  • Subject continues to have heart failure symptoms despite receiving optimal medical therapy
  • Schedule for implant of a PARADYM CRT-D (Model 8770)
  • Subject has signed and dated an informed consent form

Exclusion Criteria:

  • Any contraindication for standard cardiac pacing
  • Any contraindication for ICD therapy
  • Abdominal implantation site
  • 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 (intravenous 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 or HIPAA
  • Unavailability for scheduled follow-up at the implanting center
  • Known sensitivity to 1mg dexamethasone sodium phosphate (DSP)
  • Under guardianship
  • Age of less than 18 years
  • Pregnancy

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRT Therapy
All patients will receive CRT therapy with the Physiological Diagnosis (PhD) feature enabled.
Device: Paradym CRT + Physiological Diagnosis (PhD)
All subjects will undergo CRT therapy with the Physiological Diagnosis (PhD) feature enabled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of diagnostic feature in detecting heart failure events (using the device) in comparison to clinical heart failure events experienced by the patient (as classified by an independent committee).
Time Frame: Thirteen months
Thirteen months
Mean number of false positives per patient per year.
Time Frame: Thirteen Months
Thirteen Months

Collaborators and Investigators

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

Sponsor

ELA Medical, Inc.

Collaborators

LivaNova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2011

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 15, 2014

Last Update Submitted That Met QC Criteria

May 14, 2014

Last Verified

May 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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