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

NCT01260402 | Completed DMC

• 2 other identifiers: CHUBX 2010/122010-A00772-37
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Cardiomyopathy, Dilated; Coronary Disease

Keywords

heart failure; Cardiomyopathy, dilated; Coronary disease; Cardiac Pacing, Artificial; cardiac resynchronization therapy; Hemodynamics; Randomized Controlled Trials; Open Study

Outcome Measures

Primary Outcomes (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

  Visit 3 : implantation day, during pacing procedure

Secondary Outcomes (23)

• Implant success rate

  Visit 3 : implantation day, end of pacing procedure

• number of left ventricular pacing sites assessed

  Visit 3 : implantation day, end of pacing procedure

• Pacing Procedure duration

  Visit 3 : implantation day, end of pacing procedure

• Per and post implantation complications rate

  Visit 4 : within 7 days after pacing procedure

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

  within 7 days after pacing procedure

Study Arms (2)

Epicardial

ACTIVE COMPARATOR

Device: Resynchronization using a coronary sinus approach

Endocardial

EXPERIMENTAL

Device: Resynchronization using a transeptal approach

Interventions

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

Endocardial

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

Epicardial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Cardiologic Hospital Haut l'évêque

Pessac, 33604, France

Location

Related Publications (1)

• 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.

  PMID: 29889232 RESULT

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated; Coronary Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myocardial Ischemia; Vascular Diseases

Study Officials

• Pierre JAIS, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 15, 2010
• Study Start: March 3, 2011
• Primary Completion: January 1, 2015
• Study Completion: July 30, 2015
• Last Updated: May 14, 2026

Record last verified: 2022-02

Locations

FR (1)