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Completed

NCT Number: NCT01270646

Impact of Intraventricular Electrical Activation in Resynchronization Therapy

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.

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Key information

Conditions

Heart Failure Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Coronary Disease Genetic Diseases, Inborn Heart Diseases Laminopathies Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Pessac, 33604, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Invasive mapping with CARTO3 system and Non-Invasive mapping with CardioInsight Atlas EC Mapping system

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Number, area and location of line of conduction block in the Left Ventricle

    Time frame: Day 1 : End of CRT device implantation

  2. Area of the latest activated region of the Left Ventricle

    Time frame: Day 1 : End of CRT device implantation

  3. Number, area and location of LV region activated after the end of surface QRS

    Time frame: Day 1 : End of CRT device implantation

  4. Septal activation time (LVTAS)

    Time frame: Day 1 : End of CRT device implantation

  5. Global intra-Left Ventricular dispersion time

    Time frame: Day 1 : End of CRT device implantation

  6. Determination of the electrical parameters associated with good clinical response to CRT at 6 months.

    Time frame: 6 months after CRT device implantation

  7. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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 ®

Acronym: CARTO-CRT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 5, 2011
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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