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

January 4, 2011
April 1, 2014
January 2011
July 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01270646 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Impact of Intraventricular Electrical Activation in Resynchronization Therapy
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure
  • Cardiomyopathy, Dilated
  • Coronary Disease
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.

Experimental: Intraventricular Electrical Activation
Intervention: Device: Invasive mapping with CARTO3 system and Non-Invasive mapping with CardioInsight Atlas EC Mapping system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2015
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nicolas DERVAL, MD (0)5 57 65 64 71 ext +33 dervalnicolas@gmail.com
France
 
NCT01270646
CHUBX 2010/29
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Not Provided
University Hospital, Bordeaux
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP