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.

Verified June 2012 by University Hospital, Bordeaux

Sponsor:

Information provided by (Responsible Party):

University Hospital, Bordeaux

ClinicalTrials.gov Identifier:

NCT01260402

First received: December 8, 2010

Last updated: June 13, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 8, 2010

Last Updated Date

June 13, 2012

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01260402 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure
Cardiomyopathy, Dilated
Coronary Disease

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Epicardial
Intervention: Device: Resynchronization using a coronary sinus approach
Experimental: Endocardial
Intervention: Device: Resynchronization using a transeptal approach

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pierre JAIS, MD

(0)5 57 65 64 71 ext +33

pierre.jais@chu-bordeaux.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01260402

Other Study ID Numbers ^ICMJE

CHUBX 2010/12

Has Data Monitoring Committee

Yes

Responsible Party

University Hospital, Bordeaux

Study Sponsor ^ICMJE

University Hospital, Bordeaux

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pierre JAIS, MD

University Hospital Bordeaux, France

Information Provided By

University Hospital, Bordeaux

Verification Date

June 2012

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

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