Clinical Evaluation on Advanced Resynchronization
- Conditions
- Heart FailureCardiomyopathy
- Interventions
- Device: New Living CHF
- Registration Number
- NCT00658203
- Lead Sponsor
- LivaNova
- Brief Summary
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.
PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.
- Detailed Description
The study is a prospective, multicentre, controlled and randomised clinical investigation, with two single-blinded arms.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
The patient candidate for inclusion in the study must be indicated for implantation of a Biventricular pacing system, with the following clinical conditions:
-
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
Any patient who has one of the following characteristics will be excluded from the study:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 New Living CHF PEA optimized CRT 2 New Living CHF Standard optimized CRT
- Primary Outcome Measures
Name Time Method The primary endpoint will be evaluated at 1 year (M12), in term of improved, unchanged or worsened patient's conditions, with a composite analysis of NYHA class evolution, heart-failure-related hospitalisations and Quality of Life evaluation. 12 months
- Secondary Outcome Measures
Name Time Method PEA-CRT optimisation is at least effective as the standard optimisation in term of efficacy of the therapy and patients' quality of life. 12 months PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms. 12 months Efficacy of the therapy comparing the two arms in terms of NYHA 12 months Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality 12 months Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score 12 months Efficacy of the therapy comparing the two arms in terms of BNP dosage 12 months Efficacy of the therapy comparing the two arms in terms of Number and duration of heart-failure-related patient's hospitalisations, during the study period. 12 months Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter 12 months Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter 12 months Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction 12 months Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval 12 months Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval 12 months Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole 12 months Efficacy of the therapy comparing the two arms in terms of E velocity 12 months Efficacy of the therapy comparing the two arms in terms of A velocity 12 months Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval 12 months Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval 12 months Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation. 12 months Time spent to achieve the CRT optimal configuration during each follow-up 12 months PEA monitoring and prognostic relevance correlating the PEA diagnostic trends with the parameters used to asses the efficacy of the therapy and patients' quality of life (NYHA class, mortality, HF-hospitalisation, EuroQoL-5D score, BNP dosage, Echo 12 months (LVEF) comparing the changes Left Ventricular Ejection Fraction in the two arms with an intermediate analysis at 6 months done by a Core Centre. 6 and 12 months
Trial Locations
- Locations (34)
CHU Angers
🇫🇷Angers, France
NC Nantaises
🇫🇷Nantes, France
CHU Montpellier
🇫🇷Montpellier, France
InParys Cardiology
🇫🇷St Cloud, France
Univ Saarland
🇩🇪Homburg, Germany
St.Adolfstift
🇩🇪Reinbek, Germany
UKB Unfallkrankenhaus
🇩🇪Berlin, Germany
CHR Cardiologie A
🇫🇷Rennes, France
CHU Rouen
🇫🇷Rouen, France
Osp. B. Ramazzini
🇮🇹Carpi, Italy
Osp. Civile
🇮🇹Rieti, Italy
Osp. S. Maria Nuova
🇮🇹Florence, Italy
Osp. Univ. Careggi
🇮🇹Florence, Italy
Osp. Niguarda
🇮🇹Milan, Italy
Osp. S. Filippo Neri
🇮🇹Rome, Italy
Medisch Centrum Rijnmond-Zuid
🇳🇱Rotterdam, Netherlands
Diaconessenhuis
🇳🇱Utrecht, Netherlands
Vlietland Ziekenhuis
🇳🇱Vlaardingen, Netherlands
Isala Klinieken
🇳🇱Zwolle, Netherlands
Hosp. Clinico
🇪🇸Valencia, Spain
General Hospital
🇬🇧Eastbourne, United Kingdom
H. General Universit.
🇪🇸Valencia, Spain
Saint Peter's Hospital
🇬🇧Chertsey, United Kingdom
CH Albi
🇫🇷Albi, France
H. Virgen de las Nieves
🇪🇸Granada, Spain
University Hospital
🇬🇧Southampton, United Kingdom
Royal Hospital
🇬🇧Bournemouth, United Kingdom
Nothern General
🇬🇧Sheffield, United Kingdom
CH Yves le Foll
🇫🇷Saint-Brieuc, France
Stiftsklinikum Augustinum
🇩🇪Munchen, Germany
CHU Bordeaux
🇫🇷Bordeaux, France
CH Lomme
🇫🇷Lomme, France
CHU Poitiers
🇫🇷Poitiers, France
CH Pau
🇫🇷Pau, France