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

This study has been completed.
Information provided by (Responsible Party):
LivaNova Identifier:
First received: June 17, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
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 Intervention Phase
Heart Failure
Device: Paradym CRT 8770
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

Further study details as provided by LivaNova:

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

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

Enrollment: 520
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: PhD Device: Paradym CRT 8770

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.

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT02167789

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Sponsors and Collaborators
  More Information

Responsible Party: LivaNova Identifier: NCT02167789     History of Changes
Other Study ID Numbers: ITSY02
Study First Received: June 17, 2014
Last Updated: June 17, 2014

Keywords provided by LivaNova:
HF, diagnosis

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on April 28, 2017