Impact of Intraventricular Electrical Activation in Resynchronization Therapy (CARTO-CRT)
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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 ® |
- 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 ]
- 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: | 40 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (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 |
Inclusion Criteria:
- Adult (aged 18 or above)
- Sinus rhythm
- Patient must have signed informed consent
- Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
- Left ventricular ejection fraction <35%
- NYHA Class III or IV with optimal medical treatment
- Patient covered by national healthcare insurance
Exclusion Criteria:
- Pregnant woman
- Participation in another study
- Sequel of transmural myocardial infarction
Contacts and Locations| Contact: Nicolas DERVAL, MD | (0)5 57 65 64 71 ext +33 | dervalnicolas@gmail.com |
| 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 | |
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: | June 13, 2012 |
| 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:
|
Cardiomyopathy, Dilated Coronary Disease Coronary Artery Disease Heart Failure Cardiomyopathies Cardiomegaly |
Heart Diseases Cardiovascular Diseases Myocardial Ischemia Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 22, 2013