Clinical Evaluation on Advanced Resynchronization

LivaNova

Status and phase

Completed

Phase 4

Conditions

Cardiomyopathy

Heart Failure

Treatments

Device: New Living CHF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00658203

CLEAR - IPEA01

Details and patient eligibility

About

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.

Full 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.

Enrollment

310 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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