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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01270646
First received: January 4, 2011
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure
Cardiomyopathy, Dilated
Coronary Disease
Device: Invasive mapping with CARTO3 system and Non-Invasive mapping with CardioInsight Atlas EC Mapping system
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ®

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Evolution of the Global Left Ventricle activation time (LVATG) with and without Cardiac Resynchronization Therapy (CRT). [ Time Frame: Day 1 : End of CRT device implantation ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270646

Contacts
Contact: Nicolas DERVAL, MD (0)5 57 65 64 71 ext +33 dervalnicolas@gmail.com

Locations
France
Hôpital cardiologique du Haut-Lévêque, Pr. Haïssaguerre's department, 3rd Floor Recruiting
Pessac, France, 33604
Contact: Nicolas DERVAL, MD    (0)5 57 65 64 71 ext +33    dervalnicolas@gmail.com   
Contact: Hélène VIDEAU    (0)5 57 62 31 19 ext +33    helene.videau@chu-bordeaux.fr   
Principal Investigator: Nicolas DERVAL, MD         
Sub-Investigator: Michel HAÎSSAGUERRE, MD-PhD         
Sub-Investigator: Pierre JAÏS, MD-PhD         
Sub-Investigator: Mélèze HOCINI, MD         
Sub-Investigator: Pierre BORDACHAR, MD         
Sub-Investigator: Phillipe RITTER, MD         
Sub-Investigator: Frédéric SACHER, MD         
Sub-Investigator: Arnaud DENIS, MD         
Sub-Investigator: Maxime De GUILLEBON, MD         
Sub-Investigator: Jean-Benoit THAMBO, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01270646     History of Changes
Other Study ID Numbers: CHUBX 2010/29
Study First Received: January 4, 2011
Last Updated: April 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Cardiac insufficiency
Invasive procedure
Heart Failure
Noninvasive procedure
Congestive Heart Failure
Mapping
Cardiac resynchronisation therapy
Open study
Cardiac Pacings, Artificial
Hemodynamics

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Coronary Disease
Coronary Artery Disease
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiomegaly

ClinicalTrials.gov processed this record on September 18, 2014