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Heart Failure，CongestiveEndoCRTNCT03573427

LV Endocardial CRT for Patients With Intermediate QRS Width

An observational study of Heart Failure，Congestive and Left Ventricular Dysfunction, run by Jaimie Manlucu at 8 sites in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Trans-atrial septal placement LV lead for CRT
Type of treatment
Medical device
How many people
0 participants
Where
8 sitesCanada
Study dates
28 Apr 2016to 22 Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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%

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites

  • Queen Elizabeth II Health Science

    Halifax, Nova Scotia

  • London Health Science Centre

    London, Ontario

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec

  • McGill University Health Centre

    Montreal, Quebec

  • Montreal Heart Institute

    Montreal, Quebec

  • Sherbrooke CHUS

    Sherbrooke, Quebec

  • St. Michael's Hospital

    Toronto, Ontario

  • Vancouver General Hospital

    Vancouver, British Columbia

Other trials in Canada

About this study

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.

Being tested
Trans-atrial septal placement LV lead for CRT
Medical subject headings
Heart Failure, Ventricular Dysfunction, Left, Bundle-Branch Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trans-atrial septal placement LV lead for CRTDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LV end-systolic volume

    Echocardiogram

    Measured: Change from Baseline measure to 6 months

  2. LVEF improvement

    Echocardiogram

    Measured: Change from Baseline measure to 6 months

Secondary outcomes (6)

  1. Thromboembolic Events

    Adverse Event

    Measured: Through study completion, an average of 1 year

  2. Specific system placement procedure related adverse events

    Device Implant

    Measured: Through study completion, an average of 1 year

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

    Chest xray, device interrogation

    Measured: Through study completion, an average of 1 year

  4. Cardiac tamponade requiring intervention

    Device Implant

    Measured: Through study completion, an average of 1 year

  5. Ventricular Arrhythmias

    Device interrogation

    Measured: 6 months, 12 months

  6. Mitral Regurgitation

    Echocardiogram

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2018
  2. Study start28 Apr 2016 (estimated)
  3. Primary completion28 Apr 2019 (estimated)
  4. Study completion22 Jul 2019

Why it stopped: No patients enrolled; Executive Committee Decision;Feasibility of recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03573427
Sponsor's protocol ID
V27Mar17
Acronym
EndoCRT
Status last verified
Jul 2019
First submitted
5 Jun 2018
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure，Congestive and Left Ventricular Dysfunction, run by Jaimie Manlucu at 8 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LV end-systolic volume (time frame: Change from Baseline measure to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03573427.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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