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Clinical Evaluation on Advanced Resynchronization

Primary Purpose

Heart Failure, Cardiomyopathy

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
New Living CHF
New Living CHF
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CH Albi
  • CHU Angers
  • CHU Bordeaux
  • CH Lomme
  • CHU Montpellier
  • NC Nantaises
  • CH Pau
  • CHU Poitiers
  • CHR Cardiologie A
  • CHU Rouen
  • CH Yves le Foll
  • InParys Cardiology
  • UKB Unfallkrankenhaus
  • Univ Saarland
  • Stiftsklinikum Augustinum
  • St.Adolfstift
  • Osp. B. Ramazzini
  • Osp. Civile
  • Osp. S. Maria Nuova
  • Osp. Univ. Careggi
  • Osp. Niguarda
  • Osp. Civile
  • Osp. S. Filippo Neri
  • Medisch Centrum Rijnmond-Zuid
  • Diaconessenhuis
  • Vlietland Ziekenhuis
  • Isala Klinieken
  • H. General Universit.
  • H. Virgen de las Nieves
  • H. General Universit.
  • Hosp. Clinico
  • Royal Hospital
  • Saint Peter's Hospital
  • General Hospital
  • Nothern General
  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm Description

PEA optimized CRT

Standard optimized CRT

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PEA-CRT optimisation is at least effective as the standard optimisation in term of efficacy of the therapy and patients' quality of life.
PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.
Efficacy of the therapy comparing the two arms in terms of NYHA
Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality
Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score
Efficacy of the therapy comparing the two arms in terms of BNP dosage
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.
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter
Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction
Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval
Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval
Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole
Efficacy of the therapy comparing the two arms in terms of E velocity
Efficacy of the therapy comparing the two arms in terms of A velocity
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval
Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation.
Time spent to achieve the CRT optimal configuration during each follow-up
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
(LVEF) comparing the changes Left Ventricular Ejection Fraction in the two arms with an intermediate analysis at 6 months done by a Core Centre.

Full Information

First Posted
March 28, 2008
Last Updated
April 7, 2008
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT00658203
Brief Title
Clinical Evaluation on Advanced Resynchronization
Official Title
Clinical Evaluation on Advanced Resynchronization
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
LivaNova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
PEA optimized CRT
Arm Title
2
Arm Type
Other
Arm Description
Standard optimized CRT
Intervention Type
Device
Intervention Name(s)
New Living CHF
Intervention Description
PEA CRT optimization
Intervention Type
Device
Intervention Name(s)
New Living CHF
Intervention Description
Standard optimized CRT.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of NYHA
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of BNP dosage
Time Frame
12 months
Title
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
Title
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of E velocity
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of A velocity
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval
Time Frame
12 months
Title
Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation.
Time Frame
12 months
Title
Time spent to achieve the CRT optimal configuration during each follow-up
Time Frame
12 months
Title
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
Title
(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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
P Ritter, Dr
Organizational Affiliation
InParys Cardiologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Albi
City
Albi
Country
France
Facility Name
CHU Angers
City
Angers
Country
France
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Facility Name
CH Lomme
City
Lomme
Country
France
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Facility Name
NC Nantaises
City
Nantes
Country
France
Facility Name
CH Pau
City
Pau
Country
France
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Name
CHR Cardiologie A
City
Rennes
Country
France
Facility Name
CHU Rouen
City
Rouen
Country
France
Facility Name
CH Yves le Foll
City
Saint-Brieuc
Country
France
Facility Name
InParys Cardiology
City
St Cloud
Country
France
Facility Name
UKB Unfallkrankenhaus
City
Berlin
Country
Germany
Facility Name
Univ Saarland
City
Homburg
Country
Germany
Facility Name
Stiftsklinikum Augustinum
City
Munchen
Country
Germany
Facility Name
St.Adolfstift
City
Reinbek
Country
Germany
Facility Name
Osp. B. Ramazzini
City
Carpi
Country
Italy
Facility Name
Osp. Civile
City
Desio
Country
Italy
Facility Name
Osp. S. Maria Nuova
City
Florence
Country
Italy
Facility Name
Osp. Univ. Careggi
City
Florence
Country
Italy
Facility Name
Osp. Niguarda
City
Milan
Country
Italy
Facility Name
Osp. Civile
City
Rieti
Country
Italy
Facility Name
Osp. S. Filippo Neri
City
Rome
Country
Italy
Facility Name
Medisch Centrum Rijnmond-Zuid
City
Rotterdam
Country
Netherlands
Facility Name
Diaconessenhuis
City
Utrecht
Country
Netherlands
Facility Name
Vlietland Ziekenhuis
City
Vlaardingen
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
Country
Netherlands
Facility Name
H. General Universit.
City
Alicante
Country
Spain
Facility Name
H. Virgen de las Nieves
City
Granada
Country
Spain
Facility Name
H. General Universit.
City
Valencia
Country
Spain
Facility Name
Hosp. Clinico
City
Valencia
Country
Spain
Facility Name
Royal Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
Saint Peter's Hospital
City
Chertsey
Country
United Kingdom
Facility Name
General Hospital
City
Eastbourne
Country
United Kingdom
Facility Name
Nothern General
City
Sheffield
Country
United Kingdom
Facility Name
University Hospital
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Clinical Evaluation on Advanced Resynchronization

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