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:
University Hospital, Bordeaux
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure Cardiomyopathy, Dilated Coronary Disease |
Device: Resynchronization using a transeptal approach Device: Resynchronization using a coronary sinus approach |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Bordeaux:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Epicardial |
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 |
| Experimental: Endocardial |
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260402
Contacts
| Contact: Pierre JAIS, MD | (0)5 57 65 64 71 ext +33 | pierre.jais@chu-bordeaux.fr |
Locations
| France | |
| Cardiologic Hospital Haut l'évêque | Recruiting |
| Pessac, France, 33604 | |
| Contact: Pierre JAIS, MD (0)5 57 65 64 71 ext +33 pierre.jais@chu-bordeaux.fr | |
| Contact: Maïder PIQUET (0)5 56 79 56 79 ext +33 maider.piquet@chu-bordeaux.fr | |
| Principal Investigator: Pierre JAIS, MD | |
| Sub-Investigator: Pierre BORDACHAR, MD | |
| Sub-Investigator: Philippe RITTER, MD | |
| Sub-Investigator: Arnaud DENIS, MD | |
| Sub-Investigator: Maxime DE GUILLEBON, MD | |
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
| Principal Investigator: | Pierre JAIS, MD | University Hospital Bordeaux, France |
More Information
No publications provided
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT01260402 History of Changes |
| Other Study ID Numbers: | CHUBX 2010/12 |
| Study First Received: | December 8, 2010 |
| Last Updated: | June 13, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Bordeaux:
|
heart failure Cardiomyopathy, dilated Coronary disease Cardiac Pacing, Artificial |
cardiac resynchronization therapy Hemodynamics Randomized Controlled Trials Open Study |
Additional relevant MeSH terms:
|
Cardiomyopathy, Dilated Coronary Disease Coronary Artery Disease Heart Failure Cardiomyopathies Cardiomegaly |
Heart Diseases Cardiovascular Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on June 18, 2013