Clinical Evaluation on Advanced Resynchronization
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- LivaNova
- Enrollment
- 310
- Locations
- 34
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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.
Time Frame: 12 months
Secondary Outcomes
- 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)