Impact of Intraventricular Electrical Activation in Resynchronization Therapy

Heart Failure Clinical Trial

— CARTO-CRT  

Official title:

Study of the Role of Intraventricular Electrical Activation in the Treatment of Congestive Heart Failure by Cardiac Resynchronization Therapy: Invasive Evaluation and Validation of Non-Invasive Strategy Using CardioInsight ®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270646
• Other study ID #: CHUBX 2010/29
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Coronary Artery Disease
• Coronary Disease
• Heart Failure

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