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Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure. (EPI-ENDO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01260402
First received: December 8, 2010
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

Biventricular pacing is a validated treatment for patients suffering from heart failure resistant to medical treatment. However, up to 30% of the patients are non responsive to this strategy using the coronary sinus approach to pace the Left Ventricle (LV).

It has been demonstrated that the magnitude of the improvement was highly dependant on the LV pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing sites. Resynchronisation using a transeptal approach to pace the left ventricle on the cardiology has been shown feasible on small series. We therefore would like to compare these two approached in a randomised prospective study to confirm the hypotheses that endocardial LV pacing by offering multiple choices for the pacing sites reduces the number of non responders and is associated with greater hemodynamic benefit when compared to the conventional coronary sinus approach.


Condition Intervention
Heart Failure
Cardiomyopathy, Dilated
Coronary Disease
Device: Resynchronization using a transeptal approach
Device: Resynchronization using a coronary sinus approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • the acute hemodynamic response judged by dP/dt max [ Time Frame: Visit 3 : implantation day, during pacing procedure ] [ Designated as safety issue: No ]
    The primary outcome will be the acute hemodynamic response of the randomized pacing modality (endocardial vs epicardial Left Ventricle pacing) as judged by the highest gain in dP/dt max


Secondary Outcome Measures:
  • Implant success rate [ Time Frame: Visit 3 : implantation day, end of pacing procedure ] [ Designated as safety issue: No ]
  • number of left ventricular pacing sites assessed [ Time Frame: Visit 3 : implantation day, end of pacing procedure ] [ Designated as safety issue: No ]
  • Pacing Procedure duration [ Time Frame: Visit 3 : implantation day, end of pacing procedure ] [ Designated as safety issue: No ]
  • Per and post implantation complications rate [ Time Frame: Visit 4 : within 7 days after pacing procedure ] [ Designated as safety issue: Yes ]
  • Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for left ventricle ejection fraction [ Time Frame: within 7 days after pacing procedure ] [ Designated as safety issue: No ]
  • Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for mitral regurgitation [ Time Frame: within 7 days after pacing procedure ] [ Designated as safety issue: No ]
  • Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for atrioventricular asynchronism [ Time Frame: within 7 days after pacing procedure ] [ Designated as safety issue: No ]
  • Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for inter and intra-ventricular asynchronism [ Time Frame: within 7 days after pacing procedure ] [ Designated as safety issue: No ]
  • sensing performances of left ventricle pacing leads [ Time Frame: within 7 days after pacing procedure ] [ Designated as safety issue: No ]
  • pacing threshold performances of left ventricle pacing leads [ Time Frame: within 7 days after pacing procedure ] [ Designated as safety issue: No ]
  • impedances performances of left ventricle pacing leads [ Time Frame: within 7 days after pacing procedure ] [ Designated as safety issue: No ]
  • Complications rate at 6 month Follow up [ Time Frame: Visit 6 : 6-months after pacing procedure ] [ Designated as safety issue: Yes ]
  • Clinical benefit at 6 month Follow up: Gain in NYHA [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • Clinical benefit at 6 month Follow up: 6 minutes walk test [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • Clinical benefit at 6 month Follow up: quality of life questionnaire as compared to pre implantation [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricular Ejection Fraction [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricle volumes [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • Echocardiography at 6 month Follow up: as compared to pre implantation for mitral regurgitation [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • Echocardiography at 6 month Follow up: as compared to pre implantation for atrioventricular asynchronism [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • Echocardiography at 6 month Follow up: as compared to pre implantation for inter and intra-ventricular asynchronism [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • sensing performances of Left Ventricle pacing leads at 6 month Follow up [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • pacing threshold performances of Left Ventricle pacing leads at 6 month Follow up [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]
  • impedances performances of Left Ventricle pacing leads at 6 month Follow up [ Time Frame: 6-months after pacing procedure ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epicardial Device: Resynchronization using a coronary sinus approach

Cardiac resynchronization with one in the right ventricle and one in the left ventricle via the coronary sinus.

Devices used for procedure : RADI PressureWire, routine catheters chosen by operator

Experimental: Endocardial Device: Resynchronization using a transeptal approach

Cardiac resynchronization with one in the right ventricle and one in the left ventricle via a transeptal puncture.

Devices used for procedure : Medtronic C304 or 6227DEF, Nykanen RF Wire, RADI PressureWire


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (aged 18 or above)
  • Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
  • Left ventricular ejection fraction <35%
  • NYHA Class III or IV with optimal medical treatment
  • QRS duration > 120 ms
  • Sinus rhythm
  • Patient must have signed informed consent
  • Patient must be registered in the national health care system

Exclusion Criteria:

  • Aged under 18
  • Patient with a mitral or aortic prosthesis
  • Patient with contraindication to anti-coagulants
  • Pregnant women
  • Participation in another study
  • Patient with contraindication for left ventricle catheterization by retrograde aortic approach , as a severe aortic stenosis requiring surgery, or an ascending aorta aneurism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260402

Contacts
Contact: Pierre JAIS, MD (0)5 57 65 64 71 ext +33 pierre.jais@chu-bordeaux.fr

Locations
France
Cardiologic Hospital Haut l'évêque Recruiting
Pessac, France, 33604
Contact: Pierre JAIS, MD    (0)5 57 65 64 71 ext +33    pierre.jais@chu-bordeaux.fr   
Contact: Maïder PIQUET    (0)5 56 79 56 79 ext +33    maider.piquet@chu-bordeaux.fr   
Principal Investigator: Pierre JAIS, MD         
Sub-Investigator: Pierre BORDACHAR, MD         
Sub-Investigator: Philippe RITTER, MD         
Sub-Investigator: Arnaud DENIS, MD         
Sub-Investigator: Maxime DE GUILLEBON, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Pierre JAIS, MD University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01260402     History of Changes
Other Study ID Numbers: CHUBX 2010/12
Study First Received: December 8, 2010
Last Updated: August 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
heart failure
Cardiomyopathy, dilated
Coronary disease
Cardiac Pacing, Artificial
cardiac resynchronization therapy
Hemodynamics
Randomized Controlled Trials
Open Study

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Coronary Artery Disease
Coronary Disease
Heart Failure
Arterial Occlusive Diseases
Arteriosclerosis
Cardiomegaly
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014