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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

December 8, 2010
August 20, 2014
March 2011
March 2016   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01260402 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.
Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Cardiomyopathy, Dilated
  • Coronary Disease
  • 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

  • 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

  • Active Comparator: Epicardial
    Intervention: Device: Resynchronization using a coronary sinus approach
  • Experimental: Endocardial
    Intervention: Device: Resynchronization using a transeptal approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
September 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Pierre JAIS, MD (0)5 57 65 64 71 ext +33 pierre.jais@chu-bordeaux.fr
France
 
NCT01260402
CHUBX 2010/12
Yes
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Pierre JAIS, MD University Hospital Bordeaux, France
University Hospital, Bordeaux
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP