LV Endocardial CRT for Patients With Intermediate QRS Width (EndoCRT)

This pilot study is designed as a multi-centre cohort study determining the degree of LV reverse remodeling in patients with intermediate QRS widths (120-149ms) who undergo CRT implant with transseptal LV leads, and comparing to the average expected reverse remodeling rate in patients with standard transvenous coronary sinus leads and QRS widths ≥150ms.

Study Overview

• Status: Withdrawn
• Conditions: Left Bundle-Branch Block; Left Ventricular Dysfunction; Heart Failure，Congestive
• Intervention / Treatment: Device: Trans-atrial septal placement LV lead for CRT

Detailed Description

This is a multi-centre prospective cohort trial to establish the feasibility of endocardial CRT implants.This trial will assess feasibility of a larger scale randomized controlled study.

Patients consented to the study will receive a CRT device with or without ICD, placed in the same time frame, and will have RA and RV leads implanted as the standard of care. The device will be implanted in a facility that has the capacity to perform trans-atrial septal puncture with ultrasound guidance (TEE or ICE) at the time of implantation. The LV lead will be placed using a trans-atrial septal approach, using specially designed puncture tools and LVendo delivery tool kits specifically designed for this study. Special care will be taken to avoid the LV apex and transmural scar identified by pre-implant imaging. Electrical testing, and programming of the device will be standardized.

• Study Type: Observational

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Vancouver General Hospital
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Science
  • Ontario
    • London, Ontario, Canada
      • London Health Science Centre
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
  • Quebec
    • Montréal, Quebec, Canada
      • Centre Hospitalier de l'Universite de Montreal
    • Montréal, Quebec, Canada
      • McGill University Health Centre
    • Montréal, Quebec, Canada
      • Montreal Heart Institute
    • Sherbrooke, Quebec, Canada
      • Sherbrooke CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with left bundle branch block (LBBB) and a QRS width of 120-149 ms; ambulatory NYHA class II-IV heart failure symptoms; and a LV ejection fraction ≤ 35%

Description

Inclusion Criteria:

• Patients with NYHA Class II-IV ambulatory HF symptoms
• Optimal HF Medical Therapy of at least 3 months (2009 ACCF/AHA, ESC 2012)
• LVEF less than or equal to 35%
• Sinus rhythm (can have paroxysmal atrial fibrillation)
• QRS morphology is non-RBBB
• QRS duration 120-149 ms
• Patients with pacemaker or ICD that meet the above criteria may be upgraded to CRT-D or CRT-P
• Patients are able to receive oral anticoagulation

Exclusion Criteria:

• Patients with atrial septal defect closure
• Planned atrial fibrillation ablation within 12 months
• Patients with mitral prosthetic valve that precludes the placement of an LV lead trans-septally
• Patients with RBBB
• Patients with intra-cardiac thrombi
• Patients with permanent atrial fibrillation
• Patients with contraindications to oral anti-coagulation
• In-hospital patients with acute cardiac or non-cardiac illness that requires intensive care
• Acute coronary syndrome (including MI) < 4 weeks
• Coronary revascularization (CABG or PCI) < 3 months
• Uncorrected or uncorrectable primary valvular disease
• Restrictive, hypertrophic or reversible form of cardiomyopathy
• Severe primary pulmonary disease such as cor pulmonale
• Patients with a life expectancy of less than one year from non-cardiac cause.
• Patients included in other clinical trials that will affect the objectives of this study
• Those unable or unwilling to provide informed consent
• Those with a history of noncompliance to medical therapy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LV end-systolic volume	Echocardiogram	Change from Baseline measure to 6 months
LVEF improvement	Echocardiogram	Change from Baseline measure to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thromboembolic Events	Adverse Event	Through study completion, an average of 1 year
Specific system placement procedure related adverse events	Device Implant	Through study completion, an average of 1 year
Lead(s) dislodgement requiring repositioning or cessation of CRT	Chest xray, device interrogation	Through study completion, an average of 1 year
Cardiac tamponade requiring intervention	Device Implant	Through study completion, an average of 1 year
Ventricular Arrhythmias	Device interrogation	6 months, 12 months
Mitral Regurgitation	Echocardiogram	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Jaimie Manlucu
• Investigators: Principal Investigator: Jaimie Manlucu, MD FRCPC, Schulich School of Medicine, Western University, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): April 28, 2016
• Primary Completion (Anticipated): April 28, 2019
• Study Completion (Actual): July 22, 2019

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Block; Heart Failure; Bundle-Branch Block; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: V27Mar17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No