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

Heart Failure Clinical Trial

— CLEPSYDRA  

Official title:

Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167789
• Other study ID #: ITSY02
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2014
• Last updated: June 17, 2014
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Paradym CRT 8770

Locations

Country	Name	City	State
Canada	Dr. Champagne, Dr. Philippon	Quebec
Canada	Drs. Thibualt, Guerra	Quebec
France	Dr. Dupuis	Angers
France	Dr. Defaye	Grenoble
France	Dr. Bru	La Rochelle
France	Pr. Kacet	Lille
France	Dr. Pisapia	Marseille
France	Pr. Davy	Montpellier
France	Dr Abbey	Nantes
France	Dr. Burban	Nantes
France	Dr. Jauvert	Paris
France	Dr. Ritter	Pessac
France	Pr. Mabo	Rennes
France	Pr. Anselme	Rouen
France	Pr. Da Costa	Saint Etienne
France	Dr. Delay	Toulouse
France	Pr. Sadoul	Vandoeuvre Les Nancy
Germany	Dr. Sperzel	Bad Nauheim
Germany	Dr. Vogt	Bad Oeynhausen
Germany	Dr. Fleck - Dr. Goetze	Berlin
Germany	Dr. Schlegl	Berlin
Germany	Dr. Butter	Bernau
Germany	Pr. Brachmann	Coburg
Germany	Dr. Klein - Dr. Oswald	Hannover
Germany	Pr. Bauer	Heidelberg
Germany	Pr. Mewis - Pr. Fröhlig	Homburg
Germany	Dr. Wieckhorst	Kiel
Germany	Dr. Bonnemeier	Lübeck
Germany	Pr. Weiss	Lüneburg
Germany	Dr. Kolb	Munchen
Germany	Pr. Eckhardt	Münster
Italy	Dr. Leonardo Calo	Roma
Italy	Dr Mantovan	Treviso
Netherlands	Dr. Delnoy	Zwolle
Spain	Dr. Martinez	Alicante
Spain	Dr. Brugada	Barcelona
Spain	Dr. Peinado	Madrid
Spain	Dr. Beiras	Vigo
Switzerland	Dr Auricchio	Lugano
United Kingdom	Dr. Leyva	Birmingham
United Kingdom	Dr Fluck - Dr. Beeton	Chertsey
United Kingdom	Dr. NG	Leicester
United Kingdom	Dr. Murgatroyd	London
United Kingdom	Dr. Bowes	Sheffield
United Kingdom	Dr. Morgan	Southampton
United States	Drs. Jagmeet Singh, Kevin, Hiest	Boston	Massachusetts
United States	Dr. Gold	Charleston	South Carolina
United States	Dr. Haines	Kaplan, Phoenix,	Arizona
United States	Drs. John Fisher, Jay Gross	Montefiore, Bronx NY	New York
United States	Drs. Lewis, Garg	Siegel, Phoenix,	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HF related events		13 months
Secondary	Co morbidities		13 months