Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)

NCT02986633 | Unknown

• 1 other identifier: OBS-009
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT

Conditions

Heart Failure; Cardiac Resynchronization Therapy

Keywords

Cardiac Resynchronization Therapy; Echocardiography; Biventricular Pacing

Outcome Measures

Primary Outcomes (1)

• Changes in left ventricular end-systolic volume measured by echocardiography

  9 months after implantation

Secondary Outcomes (5)

• Death rate

  2, 4, 6, 8 and 10 years after implantation

• re-hospitalisation rate

  2, 4, 6, 8 and 10 years after implantation

• Changes in left ventricular ejection fraction measured by echocardiography

  9 months after implantation

• Changes in left ventricular end-diastolic volume measured by echocardiography

  9 months after implantation

• Changes in left ventricular longitudinal strain measured by echocardiography

  9 months after implantation

Study Arms (1)

Patients with heart failure and CRT

Heart failure with left ventricular ejection fraction less than 35 % treated with CRT

Other: Echocardiography

Interventions

Echocardiography OTHER

Patients with heart failure and CRT

Eligibility Criteria

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

Study Population

Patient with LV systolic dysfunction and QRS duration \> 120 ms receiving CRT at GHICL.

You may qualify if:

• Heart failure with left ventricular ejection fraction less than 35 %
• QRS duration over than 120 ms
• Clinical indication for CRT

You may not qualify if:

• Rythmologic indication of CRT for atrial fibrillation control
• Rythmologic indication of CRT for left ventricular ejection fraction between 35% and 45%

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (1)

Hospitals of Lille Catholic University (GHICL)

Lomme, 59462, France

RECRUITING

Related Publications (2)

• Layec J, Decroocq M, Delelis F, Appert L, Guyomar Y, Riolet C, Dumortier H, Mailliet A, Tribouilloy C, Marechaux S, Menet A. Dyssynchrony and Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Unfavorable Electrical Characteristics. JACC Cardiovasc Imaging. 2023 Jul;16(7):873-884. doi: 10.1016/j.jcmg.2022.12.023. Epub 2023 Mar 8.

  PMID: 37038875 DERIVED

• Appert L, Menet A, Altes A, Ennezat PV, Bardet-Bouchery H, Binda C, Guyomar Y, Delelis F, Castel AL, Le Goffic C, Guerbaai RA, Graux P, Tribouilloy C, Marechaux S. Clinical Significance of Electromechanical Dyssynchrony and QRS Narrowing in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy. Can J Cardiol. 2019 Jan;35(1):27-34. doi: 10.1016/j.cjca.2018.10.019. Epub 2018 Nov 14.

  PMID: 30595180 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sylvestre Maréchaux, MD, PhD

  Hospital of Lille Catholic University (GHICL)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lansiaux, MD, PhD

CONTACT

00 33 3 20 52 69; lansiaux.amelie@ghicl.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 8, 2016
• Study Start: December 1, 2014
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

FR (1)