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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00957541
First Posted: August 12, 2009
Last Update Posted: May 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
LivaNova
Information provided by (Responsible Party):
ELA Medical, Inc.
  Purpose
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.

Condition Intervention Phase
Congestive Heart Failure Device: Paradym CRT + Physiological Diagnosis (PhD) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Physiological Diagnosis Function in the Paradym CRT Device

Resource links provided by NLM:


Further study details as provided by ELA Medical, Inc.:

Primary Outcome Measures:
  • 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 ]
  • Mean number of false positives per patient per year. [ Time Frame: Thirteen Months ]

Enrollment: 520
Study Start Date: September 2009
Study Completion Date: April 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957541


Locations
United States, Arizona
Mountain Vista Hospital
Mesa, Arizona, United States, 85209
Sponsors and Collaborators
ELA Medical, Inc.
LivaNova
  More Information

Publications:
Responsible Party: ELA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00957541     History of Changes
Other Study ID Numbers: ITSY02
First Submitted: August 10, 2009
First Posted: August 12, 2009
Last Update Posted: May 15, 2014
Last Verified: May 2014

Keywords provided by ELA Medical, Inc.:
NYHA Class III or IV
Implantable Cardiac Defibrillator
Cardiac Resynchronization Therapy

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases