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

This study has been completed.
Sponsor:
Collaborator:
Sorin Group
Information provided by (Responsible Party):
ELA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00957541
First received: August 10, 2009
Last updated: May 14, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Mean number of false positives per patient per year. [ Time Frame: Thirteen Months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957541

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

Publications:
Responsible Party: ELA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00957541     History of Changes
Other Study ID Numbers: ITSY02
Study First Received: August 10, 2009
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014