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

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. Identifier: NCT02167789
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : June 19, 2014
Information provided by (Responsible Party):

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Heart Failure Device: Paradym CRT 8770 Phase 3

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  (Clinical Trial)
Actual Enrollment : 520 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT
Study Start Date : September 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
No Intervention: PhD Device: Paradym CRT 8770

Primary Outcome Measures :
  1. Number of HF related events [ Time Frame: 13 months ]

Secondary Outcome Measures :
  1. Co morbidities [ Time Frame: 13 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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)

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 identifier (NCT number): NCT02167789

  Show 50 Study Locations
Sponsors and Collaborators

Responsible Party: LivaNova Identifier: NCT02167789     History of Changes
Other Study ID Numbers: ITSY02
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: June 19, 2014
Last Verified: June 2014

Keywords provided by LivaNova:
HF, diagnosis

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases