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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01270646
Other study ID # CHUBX 2010/29
Secondary ID
Status Completed
Phase Phase 2
First received January 4, 2011
Last updated March 5, 2015
Start date January 2011
Est. completion date November 2014

Study information

Verified date March 2015
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

Impact of intraventricular electrical activation in resynchronization therapy. We seek to evaluate the impact of Cardiac Resynchronization Therapy (CRT) on electrical activation of the Left Ventricle (LV). The first goal of the study is to evaluate if CRT is able to decrease the heterogeneity of LV activation in heart failure patients. A second goal is to evaluate the electrical determinant of clinical response to CRT using invasive and non-invasive mapping technology.


Description:

Comprehensive study, prospective, monocentric and cohort study.

Biventricular pacing is an effective therapy to improve end stage heart failure patients, however up to 30% of patients are unresponsive to this therapy. Among others, optimization of Left Ventricle (LV) pacing site location is critical to optimize response to Cardiac Resynchronization Therapy (CRT). Whether a better comprehension of baseline LV electrical activation can help to determine optimal LV lead location remains to be investigated.

After informed consent patients are included in the sudy. Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the LV cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Quantitative parameters: Global LV activation time (LVATG) (primary outcome); septal activation time (LVTAS); Global intra-LV dispersion time and Qualitative parameters: presence of intraLV line of block, area of late activation. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping. A 3 and 6 months follow-up visit including clinical, biological evaluation (NYHA status, 6-min walking test, BNP) of the patients will be performed with an additional transthoracic echocardiography at 6 months.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date November 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult (aged 18 or above)

- Sinus rhythm

- Patient must have signed informed consent

- Cardiac insufficiency of whatever cause (ischemic or non-ischemic)

- Patient eligible for implantation of a ventricular resynchronization device or patient with a ventricular resynchronization device having a procedure of ventricular tachycardia ablation

- Left ventricular ejection fraction <35%

- NYHA Class II to IV with optimal medical treatment

- Patient covered by national healthcare insurance

Exclusion Criteria:

- Pregnant woman

- Sequel of transmural myocardial infarction

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Invasive mapping with CARTO3 system and Non-Invasive mapping with CardioInsight Atlas EC Mapping system
Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the Left Ventricle (LV) cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT. Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping.

Locations

Country Name City State
France Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor Pessac

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of the Global Left Ventricle activation time (LVATG) with and without Cardiac Resynchronization Therapy (CRT). Day 1 : End of CRT device implantation No
Secondary Number, area and location of line of conduction block in the Left Ventricle Day 1 : End of CRT device implantation No
Secondary Area of the latest activated region of the Left Ventricle Day 1 : End of CRT device implantation No
Secondary Number, area and location of LV region activated after the end of surface QRS Day 1 : End of CRT device implantation No
Secondary Septal activation time (LVTAS) Day 1 : End of CRT device implantation No
Secondary Global intra-Left Ventricular dispersion time Day 1 : End of CRT device implantation No
Secondary Determination of the electrical parameters associated with good clinical response to CRT at 6 months. 6 months after CRT device implantation No
Secondary Non-invasive mapping: Same criteria evaluated non-invasively using CardioInsight ® with and without Cardiac Resynchronization Therapy activated. Between 3 to 7 days after CRT device implantation No
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