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Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device | Clinical Trials | Clareo Health

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

Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

NCT02167789•LivaNova

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).

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+11 more criteria

Locations (50)

Dr. Haines

Kaplan, Phoenix,, Arizona, United States

Drs. Lewis, Garg

Siegel, Phoenix,, Arizona, United States

Drs. Jagmeet Singh, Kevin, Hiest

Boston, Massachusetts, United States

Drs. John Fisher, Jay Gross

Montefiore, Bronx NY, New York, United States

Dr. Gold

Charleston, South Carolina, United States

Dr. Champagne, Dr. Philippon

Québec, Quebec, Canada

Drs. Thibualt, Guerra

Québec, Quebec, Canada

Dr. Dupuis

Angers, Angers, France

Dr. Defaye

Grenoble, Grenoble, France

Dr. Bru

La Rochelle, La Rochelle, France

Key Dates

Start Date

September 1, 2009

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

June 19, 2014

Enrollment

520

ACTUAL participants

Conditions

Heart Failure

Interventions

Paradym CRT 8770

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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