Revisit the Value of Imaging in Best Using CArdiac Resynchronization Therapy

NCT02528032 | Completed

• 1 other identifier: 35RC14-9767
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Many studies have shown the benefits of cardiac resynchronization therapy (CRT) with biventricular pacing in patients with heart failure with left ventricular dysfunction. CRT restores contraction coordination between different regions of the left ventricle, which yields a significant improvement in LV systolic function, symptoms, exercise tolerance and quality of life. In the longer term, treatment with resynchronization induces a reverse remodeling of the left ventricle and a decrease in mortality and morbidity (hospitalization for heart failure). Nevertheless, even if a majority of patients treated with CRT feel the benefit, some (up to 40% depending on the response criteria of CRT) do not experience significant improvement (nonresponders). Echocardiography and imaging have not so far demonstrated their added value to optimize delivery of CRT. Monocentric promising work on limited numbers of patients, however, were carried out. Meanwhile, equipment for delivering CRT evolves and new probes with four poles stimulation of the left ventricle are now used. The objective of this research is to validate new sequences of ultrasound processing estimating the CRT. These tools are based on usual echocardiographic examination of patients

Conditions

Cardiac Resynchronization Therapy

Keywords

Left ventricular dysfunction; Other cardiac dysrhythmias

Outcome Measures

Primary Outcomes (1)

• Measuring the prognostic value of a package of new ultrasonic signal processing tools

  To evaluate the prognostic value of a package of new tools quantitatively measuring mechanical dyssynchrony prior to implantation of a resynchronization pacemaker in terms of favorable response at 6 months.

  pre-implantation

Secondary Outcomes (4)

• Compare pre and post-implantation asynchrony characterisation

  pre-implantation, and within three day post implantation

• Characterization of the pre-implantation mechanical asynchrony by package of new tools

  pre-implantation

• Analysis and comparison of cardiac mechanical asynchrony characterization tools with other asynchronism criteria already describe

  at 6 month

• Prediction score

  at 6 month

Study Arms (1)

Echocardiographic evaluation

OTHER

Echocardiographic evaluation of heart function with new processing tools

Other: Echographic evaluation of heart function

Interventions

Echographic evaluation of heart function OTHER

Echocardiographic data collection and analysis, not fully exploited at present

Echocardiographic evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with sinus rhythm sent to hospital for a cardiac resynchronization according to ESC criteria and implanted with a left ventricular pacing lead quadrupole

You may not qualify if:

• Patients with an acoustic window is incompatible with the accurate echographic assessment of heart function
• Patients with spontaneous one year prognosis is not dependent on his heart or another disease to the forefront (eg neoplasia)
• Contra-indications to MRI (pacemaker or implantable defibrillator, intracranial ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body, Starr-Edwards heart valve prosthesis pre 6000, biomedical device type pump insulin or neurostimulator) or against -indications to iodinated contrast injection (severe renal impairment, allergy).
• Patient not giving free and informed consent.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Pontchaillou

Rennes, 35000, France

Location

Related Publications (7)

• Galli E, Le Rolle V, Smiseth OA, Duchenne J, Aalen JM, Larsen CK, Sade EA, Hubert A, Anilkumar S, Penicka M, Linde C, Leclercq C, Hernandez A, Voigt JU, Donal E. Importance of Systematic Right Ventricular Assessment in Cardiac Resynchronization Therapy Candidates: A Machine Learning Approach. J Am Soc Echocardiogr. 2021 May;34(5):494-502. doi: 10.1016/j.echo.2020.12.025. Epub 2021 Jan 7.

  PMID: 33422667 RESULT

• Aalen JM, Donal E, Larsen CK, Duchenne J, Lederlin M, Cvijic M, Hubert A, Voros G, Leclercq C, Bogaert J, Hopp E, Fjeld JG, Penicka M, Linde C, Aalen OO, Kongsgard E, Galli E, Voigt JU, Smiseth OA. Imaging predictors of response to cardiac resynchronization therapy: left ventricular work asymmetry by echocardiography and septal viability by cardiac magnetic resonance. Eur Heart J. 2020 Oct 14;41(39):3813-3823. doi: 10.1093/eurheartj/ehaa603.

  PMID: 32918449 RESULT

• Donal E, Hubert A, Le Rolle V, Leclercq C, Martins R, Mabo P, Galli E, Hernandez A. New Multiparametric Analysis of Cardiac Dyssynchrony: Machine Learning and Prediction of Response to CRT. JACC Cardiovasc Imaging. 2019 Sep;12(9):1887-1888. doi: 10.1016/j.jcmg.2019.03.009. Epub 2019 Apr 17. No abstract available.

  PMID: 31005538 RESULT

• Galli E, Hubert A, Le Rolle V, Hernandez A, Smiseth OA, Mabo P, Leclercq C, Donal E. Myocardial constructive work and cardiac mortality in resynchronization therapy candidates. Am Heart J. 2019 Jun;212:53-63. doi: 10.1016/j.ahj.2019.02.008. Epub 2019 Mar 4.

  PMID: 30951976 RESULT

• Donal E, Galli E, Cosyns B. Twenty years after starting cardiac resynchronization therapy, do we understand the electromechanical coupling? Eur Heart J Cardiovasc Imaging. 2019 Mar 1;20(3):257-259. doi: 10.1093/ehjci/jey152. No abstract available.

  PMID: 30371762 RESULT

• Galli E, Leclercq C, Hubert A, Bernard A, Smiseth OA, Mabo P, Samset E, Hernandez A, Donal E. Role of myocardial constructive work in the identification of responders to CRT. Eur Heart J Cardiovasc Imaging. 2018 Sep 1;19(9):1010-1018. doi: 10.1093/ehjci/jex191.

  PMID: 28954293 RESULT

• Galli E, Leclercq C, Fournet M, Hubert A, Bernard A, Smiseth OA, Mabo P, Samset E, Hernandez A, Donal E. Value of Myocardial Work Estimation in the Prediction of Response to Cardiac Resynchronization Therapy. J Am Soc Echocardiogr. 2018 Feb;31(2):220-230. doi: 10.1016/j.echo.2017.10.009. Epub 2017 Dec 13.

  PMID: 29246513 RESULT

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Erwan Donal, MD/PH/Prof

  Rennes UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 19, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (1)