Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
310 participants
INTERVENTIONAL
2005-11-30
2008-02-29
Brief Summary
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PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.
Detailed Description
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The objective of the study is to compare the clinical benefits of Cardiac Resynchronisation Therapy (CRT) optimised by automatic PEA sensor features (PEA-CRT), with those obtained by standard optimisation procedure (STD-CRT).
The patient candidate for inclusion in the study has a severe chronic Heart Failure, indicated for the implantation of a Biventricular pacing system according to updated ESC guidelines (2005).
All patients included in the study will be followed-up for 1 year; patient's follow-ups are scheduled during hospitalisation, at one month, 3 months, 6 months and one year after implantation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
PEA optimized CRT
New Living CHF
PEA CRT optimization
2
Standard optimized CRT
New Living CHF
Standard optimized CRT.
Interventions
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New Living CHF
PEA CRT optimization
New Living CHF
Standard optimized CRT.
Eligibility Criteria
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Inclusion Criteria
* Severe Heart Failure (NYHA Class III or IV)
* Cardiomyopathy of any etiology
* Sinus rhythm
* Reduced Left-Ventricular Ejection Fraction
* Left-Ventricular End Diastolic Diameter greater than or equal to 30 mm/m2 (LVEDD\>30 mm/m2)
* QRS Duration:
* \> 150 ms or
* \> 120 ms and documented Mechanical Dissynchrony (by ECHO) meeting two out of three of the following criteria:
* Aortic Pre-Ejection Delay \> 140 ms
* Interventricular Mechanical Delay \> 40 ms
* Delayed activation of postero-lateral Left Ventricular wall (after mitral valve opening)
* Optimal and stable (1 month before inclusion) pharmacological treatment, including, if tolerated, Beta Blockers, Angiotensin-Converting Enzyme (ACE) Inhibitors or ACE Inhibitor substitutes, Spironolactone, and diuretics
Exclusion Criteria
* ICD indication (Life-threatening ventricular arrhythmias)
* Persistent or permanent Atrial Arrhythmia without possibility to restore sinus rhythm (spontaneous termination, anti-tachycardia pacing, pharmacological or electrical cardioversion).
* Patient already implanted with a conventional pacemaker device
* Myocardial infarction within the last three months
* Heart surgery, or revascularization within the last three months, or expected
* Heart surgery refused because of co-morbidity factors
* Included in transplantation list
* Already enrolled in other study
* Life expectancy less than 1 year
* Pregnancy
* Age less than 18
* Forfeiture of freedom or under guardianship
* Not able to understand the aim of the study and its procedures
* Refusing to cooperate
18 Years
ALL
No
Sponsors
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LivaNova
INDUSTRY
Responsible Party
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InParys
Principal Investigators
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P Ritter, Dr
Role: PRINCIPAL_INVESTIGATOR
InParys Cardiologie
Locations
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CH Albi
Albi, , France
CHU Angers
Angers, , France
CHU Bordeaux
Bordeaux, , France
CH Lomme
Lomme, , France
CHU Montpellier
Montpellier, , France
NC Nantaises
Nantes, , France
CH Pau
Pau, , France
CHU Poitiers
Poitiers, , France
CHR Cardiologie A
Rennes, , France
CHU Rouen
Rouen, , France
CH Yves le Foll
Saint-Brieuc, , France
InParys Cardiology
Saint-Cloud, , France
UKB Unfallkrankenhaus
Berlin, , Germany
Univ Saarland
Homburg, , Germany
Stiftsklinikum Augustinum
München, , Germany
St.Adolfstift
Reinbek, , Germany
Osp. B. Ramazzini
Carpi, , Italy
Osp. Civile
Desio, , Italy
Osp. S. Maria Nuova
Florence, , Italy
Osp. Univ. Careggi
Florence, , Italy
Osp. Niguarda
Milan, , Italy
Osp. Civile
Rieti, , Italy
Osp. S. Filippo Neri
Rome, , Italy
Medisch Centrum Rijnmond-Zuid
Rotterdam, , Netherlands
Diaconessenhuis
Utrecht, , Netherlands
Vlietland Ziekenhuis
Vlaardingen, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
H. General Universit.
Alicante, , Spain
H. Virgen de las Nieves
Granada, , Spain
H. General Universit.
Valencia, , Spain
Hosp. Clinico
Valencia, , Spain
Royal Hospital
Bournemouth, , United Kingdom
Saint Peter's Hospital
Chertsey, , United Kingdom
General Hospital
Eastbourne, , United Kingdom
Nothern General
Sheffield, , United Kingdom
University Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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CLEAR - IPEA01
Identifier Type: -
Identifier Source: org_study_id