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WithdrawnNCT03573427EndoCRTUpdated Jul 24, 2019

LV Endocardial CRT for Patients With Intermediate QRS Width

An observational study in Heart Failure，Congestive, Left Ventricular Dysfunction and Left Bundle-Branch Block, sponsored by Jaimie Manlucu. Withdrawn at 8 sites in Canada. Per ClinicalTrials.gov, last updated 2019-07-24.

Sponsored by Jaimie Manlucu · Observational

Why this study was withdrawn
No patients enrolled; Executive Committee Decision;Feasibility of recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Heart Failure，Congestive
  • Left Ventricular Dysfunction
  • Left Bundle-Branch Block
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

Browse Heart Failure studies →

Lead sponsor

This is the only study on the registry with Jaimie Manlucu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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%

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Interventions

  • DeviceTrans-atrial septal placement LV lead for CRT
06

What researchers measure

Primary outcomes

  1. LV end-systolic volume

    Echocardiogram

    Time frame: Change from Baseline measure to 6 months

  2. LVEF improvement

    Echocardiogram

    Time frame: Change from Baseline measure to 6 months

Secondary outcomes

  1. Thromboembolic Events

    Adverse Event

    Time frame: Through study completion, an average of 1 year

  2. Specific system placement procedure related adverse events

    Device Implant

    Time frame: Through study completion, an average of 1 year

  3. Lead(s) dislodgement requiring repositioning or cessation of CRT

    Chest xray, device interrogation

    Time frame: Through study completion, an average of 1 year

  4. Cardiac tamponade requiring intervention

    Device Implant

    Time frame: Through study completion, an average of 1 year

  5. Ventricular Arrhythmias

    Device interrogation

    Time frame: 6 months, 12 months

  6. Mitral Regurgitation

    Echocardiogram

    Time frame: Baseline, 6 months

07

Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03573427
Lead sponsor
Jaimie Manlucu
Responsible party
Jaimie Manlucu (MD, FRCPC, London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's) — Sponsor-investigator
First posted
Jun 29, 2018
Start date
Apr 28, 2016 (estimated)
Primary completion
Apr 28, 2019 (estimated)
Completion
Jul 22, 2019
Last update
Jul 24, 2019

Study contacts

Jaimie Manlucu, MD FRCPC
principal investigator · Schulich School of Medicine, Western University, London Health Sciences Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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