Clinical Evaluation on Advanced Resynchronization

Heart Failure Clinical Trial

Official title:

Clinical Evaluation on Advanced Resynchronization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658203
• Other study ID #: CLEAR - IPEA01
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2008
• Last updated: April 7, 2008
• Start date: November 2005
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeGermany: Ethics CommissionItaly: Ethics CommitteeSpain: Ethics CommitteeUnited Kingdom: Research Ethics CommitteeSlovenia: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure

Intervention

Device:
• New Living CHF
PEA CRT optimization
• New Living CHF
Standard optimized CRT.

Locations

Country	Name	City	State
France	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	St Cloud
Germany	UKB Unfallkrankenhaus	Berlin
Germany	Univ Saarland	Homburg
Germany	Stiftsklinikum Augustinum	Munchen
Germany	St.Adolfstift	Reinbek
Italy	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
Netherlands	Medisch Centrum Rijnmond-Zuid	Rotterdam
Netherlands	Diaconessenhuis	Utrecht
Netherlands	Vlietland Ziekenhuis	Vlaardingen
Netherlands	Isala Klinieken	Zwolle
Spain	H. General Universit.	Alicante
Spain	H. Virgen de las Nieves	Granada
Spain	H. General Universit.	Valencia
Spain	Hosp. Clinico	Valencia
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of NYHA		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of BNP dosage		12 months	No
Secondary	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	Yes
Secondary	Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of E velocity		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of A velocity		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval		12 months	No
Secondary	Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation.		12 months	No
Secondary	Time spent to achieve the CRT optimal configuration during each follow-up		12 months	No
Secondary	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	No
Secondary	(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	No