Clinical Evaluation on Advanced Resynchronization
1 other identifier
interventional
310
6 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 heart-failure
Started Nov 2005
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedApril 14, 2008
April 1, 2008
2.3 years
March 28, 2008
April 7, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 months
Secondary Outcomes (21)
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
PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.
12 months
Efficacy of the therapy comparing the two arms in terms of NYHA
12 months
Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality
12 months
Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score
12 months
- +16 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORPEA optimized CRT
2
OTHERStandard optimized CRT
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LivaNovalead
Study Sites (36)
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
Saint-Cloud, France
UKB Unfallkrankenhaus
Berlin, Germany
Univ Saarland
Homburg, Germany
Stiftsklinikum Augustinum
München, Germany
St.Adolfstift
Reinbek, Germany
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
Medisch Centrum Rijnmond-Zuid
Rotterdam, Netherlands
Diaconessenhuis
Utrecht, Netherlands
Vlietland Ziekenhuis
Vlaardingen, Netherlands
Isala Klinieken
Zwolle, Netherlands
H. General Universit.
Alicante, Spain
H. Virgen de las Nieves
Granada, Spain
H. General Universit.
Valencia, Spain
Hosp. Clinico
Valencia, Spain
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
P Ritter, Dr
InParys Cardiologie
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 14, 2008
Study Start
November 1, 2005
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 14, 2008
Record last verified: 2008-04