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Heart FailureEPI-ENDONCT01260402

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

A study testing Resynchronization using a transeptal approach and Resynchronization using a coronary sinus approach in people with Heart Failure and Cardiomyopathy, Dilated, run by University Hospital, Bordeaux at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resynchronization using a transeptal approach and Resynchronization using a coronary sinus approach
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteFrance
Study dates
3 Mar 2011to 30 Jul 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Cardiologic Hospital Haut l'évêque

    Pessac, 33604

Other trials in France

About this study

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.

Being tested
Resynchronization using a transeptal approach, Resynchronization using a coronary sinus approach
Keywords
heart failure, Cardiomyopathy, dilated, Coronary disease, Cardiac Pacing, Artificial, cardiac resynchronization therapy, Hemodynamics, Randomized Controlled Trials, Open Study
Medical subject headings
Heart Failure, Cardiomyopathy, Dilated, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resynchronization using a transeptal approachDevice

    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 approachDevice

    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 groups in NCT01260402
Study groupRoleWhat they receive
EpicardialActive comparatorNot described
Receives: Device: Resynchronization using a coronary sinus approach
EndocardialExperimentalNot described
Receives: Device: Resynchronization using a transeptal approach

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: Visit 3 : implantation day, during pacing procedure

Secondary outcomes (23)

  1. Implant success rate

    Measured: Visit 3 : implantation day, end of pacing procedure

  2. number of left ventricular pacing sites assessed

    Measured: Visit 3 : implantation day, end of pacing procedure

  3. Pacing Procedure duration

    Measured: Visit 3 : implantation day, end of pacing procedure

  4. Per and post implantation complications rate

    Measured: Visit 4 : within 7 days after pacing procedure

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

    Measured: within 7 days after pacing procedure

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

    Measured: within 7 days after pacing procedure

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

    Measured: within 7 days after pacing procedure

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

    Measured: within 7 days after pacing procedure

  9. sensing performances of left ventricle pacing leads

    Measured: within 7 days after pacing procedure

  10. pacing threshold performances of left ventricle pacing leads

    Measured: within 7 days after pacing procedure

  11. impedances performances of left ventricle pacing leads

    Measured: within 7 days after pacing procedure

  12. Complications rate at 6 month Follow up

    Measured: Visit 6 : 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

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

    Measured: 6-months after pacing procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2010 (estimated)
  2. Study start3 Mar 2011
  3. Primary completionJan 2015
  4. Study completion30 Jul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01260402
Sponsor's protocol ID
CHUBX 2010/12
Other IDs
2010-A00772-37
Acronym
EPI-ENDO
Status last verified
Feb 2022
First submitted
8 Dec 2010
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Kitamura T, Martin R, Frontera A, Jais P. Atrial tachycardia originating from deep septum following catheter ablation for persistent atrial fibrillation. Europace. 2018 Oct 1;20(10):1590. doi: 10.1093/europace/euy060. No abstract available.

    PubMed 29889232

Questions about this trial

What is this clinical trial studying?

A study testing Resynchronization using a transeptal approach and Resynchronization using a coronary sinus approach in people with Heart Failure and Cardiomyopathy, Dilated, run by University Hospital, Bordeaux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the acute hemodynamic response judged by dP/dt max (time frame: Visit 3 : implantation day, during pacing procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01260402, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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