Clinical trial NCT00658203: Clinical Evaluation on Advanced Resynchronization
Official title: Clinical Evaluation on Advanced Resynchronization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Cardiomyopathy
Keywords: CRT-P
PEA
Severe Heart Failure (NYHA Class III or IV)
Cardiomyopathy of any etiology
Sinus rhythm
Reduced Left-Ventricular Ejection Fraction
LVEDD>30 mm/m2
QRS Duration: > 150 ms or > 120 ms
Aortic Pre-Ejection Delay > 140 ms
Interventricular Mechanical Delay > 40 ms
Delayed activation of postero-lateral Left Ventricular wall
Optimal and stable pharmacological treatment
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
    * 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:

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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: PEA-CRT optimisation is at least effective as the standard optimisation in term of efficacy of the therapy and patients' quality of life.
timeFrame: 12 months
measure: PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of NYHA
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of BNP dosage
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of E velocity
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of A velocity
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval
timeFrame: 12 months
measure: Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation.
timeFrame: 12 months
measure: Time spent to achieve the CRT optimal configuration during each follow-up
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: (LVEF) comparing the changes Left Ventricular Ejection Fraction in the two arms with an intermediate analysis at 6 months done by a Core Centre.
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Albi
country: France
facility: CH Albi
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lomme
country: France
facility: CH Lomme
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: NC Nantaises
city: Pau
country: France
facility: CH Pau
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: CHR Cardiologie A
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Brieuc
country: France
facility: CH Yves le Foll
city: St Cloud
country: France
facility: InParys Cardiology
city: Berlin
country: Germany
facility: UKB Unfallkrankenhaus
city: Homburg
country: Germany
facility: Univ Saarland
city: Munchen
country: Germany
facility: Stiftsklinikum Augustinum
city: Reinbek
country: Germany
facility: St.Adolfstift
city: Carpi
country: Italy
facility: Osp. B. Ramazzini
city: Desio
country: Italy
facility: Osp. Civile
city: Florence
country: Italy
facility: Osp. S. Maria Nuova
city: Florence
country: Italy
facility: Osp. Univ. Careggi
city: Milan
country: Italy
facility: Osp. Niguarda
city: Rieti
country: Italy
facility: Osp. Civile
city: Rome
country: Italy
facility: Osp. S. Filippo Neri
city: Rotterdam
country: Netherlands
facility: Medisch Centrum Rijnmond-Zuid
city: Utrecht
country: Netherlands
facility: Diaconessenhuis
city: Vlaardingen
country: Netherlands
facility: Vlietland Ziekenhuis
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Alicante
country: Spain
facility: H. General Universit.
city: Granada
country: Spain
facility: H. Virgen de las Nieves
city: Valencia
country: Spain
facility: H. General Universit.
city: Valencia
country: Spain
facility: Hosp. Clinico
city: Bournemouth
country: United Kingdom
facility: Royal Hospital
city: Chertsey
country: United Kingdom
facility: Saint Peter's Hospital
city: Eastbourne
country: United Kingdom
facility: General Hospital
city: Sheffield
country: United Kingdom
facility: Nothern General
city: Southampton
country: United Kingdom
facility: University Hospital
Study officials:
affiliation: InParys Cardiologie
name: P Ritter, Dr
role: PRINCIPAL_INVESTIGATOR
References: