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Completed

NCT Number: NCT01260402

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.

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Key information

Conditions

Heart Failure Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Disease Genetic Diseases, Inborn Heart Diseases Laminopathies Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiologic Hospital Haut l'évêque

Pessac, 33604, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resynchronization using a transeptal approach

Device

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

Resynchronization using a coronary sinus approach

Device

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

Primary outcomes

  1. the acute hemodynamic response judged by dP/dt max

    Time frame: Visit 3 : implantation day, during pacing procedure

    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 outcomes

  1. Implant success rate

    Time frame: Visit 3 : implantation day, end of pacing procedure

  2. number of left ventricular pacing sites assessed

    Time frame: Visit 3 : implantation day, end of pacing procedure

  3. Pacing Procedure duration

    Time frame: Visit 3 : implantation day, end of pacing procedure

  4. Per and post implantation complications rate

    Time frame: Visit 4 : within 7 days after pacing procedure

  5. Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for left ventricle ejection fraction

    Time frame: within 7 days after pacing procedure

  6. Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for mitral regurgitation

    Time frame: within 7 days after pacing procedure

  7. Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for atrioventricular asynchronism

    Time frame: within 7 days after pacing procedure

  8. Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for inter and intra-ventricular asynchronism

    Time frame: within 7 days after pacing procedure

  9. sensing performances of left ventricle pacing leads

    Time frame: within 7 days after pacing procedure

  10. pacing threshold performances of left ventricle pacing leads

    Time frame: within 7 days after pacing procedure

  11. impedances performances of left ventricle pacing leads

    Time frame: within 7 days after pacing procedure

  12. Complications rate at 6 month Follow up

    Time frame: Visit 6 : 6-months after pacing procedure

  13. Clinical benefit at 6 month Follow up: Gain in NYHA

    Time frame: 6-months after pacing procedure

  14. Clinical benefit at 6 month Follow up: 6 minutes walk test

    Time frame: 6-months after pacing procedure

  15. Clinical benefit at 6 month Follow up: quality of life questionnaire as compared to pre implantation

    Time frame: 6-months after pacing procedure

  16. Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricular Ejection Fraction

    Time frame: 6-months after pacing procedure

  17. Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricle volumes

    Time frame: 6-months after pacing procedure

  18. Echocardiography at 6 month Follow up: as compared to pre implantation for mitral regurgitation

    Time frame: 6-months after pacing procedure

  19. Echocardiography at 6 month Follow up: as compared to pre implantation for atrioventricular asynchronism

    Time frame: 6-months after pacing procedure

  20. Echocardiography at 6 month Follow up: as compared to pre implantation for inter and intra-ventricular asynchronism

    Time frame: 6-months after pacing procedure

  21. sensing performances of Left Ventricle pacing leads at 6 month Follow up

    Time frame: 6-months after pacing procedure

  22. pacing threshold performances of Left Ventricle pacing leads at 6 month Follow up

    Time frame: 6-months after pacing procedure

  23. impedances performances of Left Ventricle pacing leads at 6 month Follow up

    Time frame: 6-months after pacing procedure

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: EPI-ENDO

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 15, 2010
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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