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Clinical Evaluation on Advanced Resynchronization

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ClinicalTrials.gov Identifier: NCT00658203
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : April 14, 2008
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Heart Failure Cardiomyopathy Device: New Living CHF Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Evaluation on Advanced Resynchronization
Study Start Date : November 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: 1
PEA optimized CRT
Device: New Living CHF
PEA CRT optimization

2
Standard optimized CRT
Device: New Living CHF
Standard optimized CRT.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. PEA-CRT optimisation is at least effective as the standard optimisation in term of efficacy of the therapy and patients' quality of life. [ Time Frame: 12 months ]
  2. PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms. [ Time Frame: 12 months ]
  3. Efficacy of the therapy comparing the two arms in terms of NYHA [ Time Frame: 12 months ]
  4. Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality [ Time Frame: 12 months ]
  5. Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score [ Time Frame: 12 months ]
  6. Efficacy of the therapy comparing the two arms in terms of BNP dosage [ Time Frame: 12 months ]
  7. 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. [ Time Frame: 12 months ]
  8. Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter [ Time Frame: 12 months ]
  9. Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter [ Time Frame: 12 months ]
  10. Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction [ Time Frame: 12 months ]
  11. Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval [ Time Frame: 12 months ]
  12. Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval [ Time Frame: 12 months ]
  13. Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole [ Time Frame: 12 months ]
  14. Efficacy of the therapy comparing the two arms in terms of E velocity [ Time Frame: 12 months ]
  15. Efficacy of the therapy comparing the two arms in terms of A velocity [ Time Frame: 12 months ]
  16. Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval [ Time Frame: 12 months ]
  17. Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval [ Time Frame: 12 months ]
  18. Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation. [ Time Frame: 12 months ]
  19. Time spent to achieve the CRT optimal configuration during each follow-up [ Time Frame: 12 months ]
  20. 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 [ Time Frame: 12 months ]
  21. (LVEF) comparing the changes Left Ventricular Ejection Fraction in the two arms with an intermediate analysis at 6 months done by a Core Centre. [ Time Frame: 6 and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658203


Locations
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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, France
Germany
UKB Unfallkrankenhaus
Berlin, Germany
Univ Saarland
Homburg, Germany
Stiftsklinikum Augustinum
Munchen, Germany
St.Adolfstift
Reinbek, Germany
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, Italy
Netherlands
Medisch Centrum Rijnmond-Zuid
Rotterdam, Netherlands
Diaconessenhuis
Utrecht, Netherlands
Vlietland Ziekenhuis
Vlaardingen, Netherlands
Isala Klinieken
Zwolle, Netherlands
Spain
H. General Universit.
Alicante, Spain
H. Virgen de las Nieves
Granada, Spain
H. General Universit.
Valencia, Spain
Hosp. Clinico
Valencia, Spain
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, United Kingdom
Sponsors and Collaborators
LivaNova
Investigators
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Principal Investigator: P Ritter, Dr InParys Cardiologie

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Responsible Party: P. RITTER - Principal investigator, InParys
ClinicalTrials.gov Identifier: NCT00658203     History of Changes
Other Study ID Numbers: CLEAR - IPEA01
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: April 2008
Keywords provided by LivaNova:
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
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases