Impact of Intraventricular Electrical Activation in Resynchronization Therapy (CARTO-CRT)

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 ®

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Coronary Disease; Cardiomyopathy, Dilated
• Intervention / Treatment: Device: Invasive mapping with CARTO3 system and Non-Invasive mapping with CardioInsight Atlas EC Mapping system

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intraventricular Electrical Activation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution of the Global Left Ventricle activation time (LVATG) with and without Cardiac Resynchronization Therapy (CRT).	Day 1 : End of CRT device implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Number, area and location of line of conduction block in the Left Ventricle	Day 1 : End of CRT device implantation
Area of the latest activated region of the Left Ventricle	Day 1 : End of CRT device implantation
Number, area and location of LV region activated after the end of surface QRS	Day 1 : End of CRT device implantation
Septal activation time (LVTAS)	Day 1 : End of CRT device implantation
Global intra-Left Ventricular dispersion time	Day 1 : End of CRT device implantation
Determination of the electrical parameters associated with good clinical response to CRT at 6 months.	6 months after CRT device implantation
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Publications and helpful links

General Publications

• Huntjens PR, Ploux S, Strik M, Walmsley J, Ritter P, Haissaguerre M, Prinzen FW, Delhaas T, Lumens J, Bordachar P. Electrical Substrates Driving Response to Cardiac Resynchronization Therapy: A Combined Clinical-Computational Evaluation. Circ Arrhythm Electrophysiol. 2018 Apr;11(4):e005647. doi: 10.1161/CIRCEP.117.005647.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: January 4, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Estimate): March 6, 2015
• Last Update Submitted That Met QC Criteria: March 5, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Heart Failure; Hemodynamics; Congestive Heart Failure; Mapping; Cardiac resynchronisation therapy; Cardiac insufficiency; Open study; Invasive procedure; Noninvasive procedure; Cardiac Pacings, Artificial
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Heart Failure; Coronary Disease; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: CHUBX 2010/29