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.
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
- Conditions the study is for
- Heart Failure，Congestive, Left Ventricular Dysfunction, Left Bundle-Branch Block
- 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
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.
LV end-systolic volume
Echocardiogram
Measured: Change from Baseline measure to 6 months
LVEF improvement
Echocardiogram
Measured: Change from Baseline measure to 6 months
Secondary outcomes (6)
Thromboembolic Events
Adverse Event
Measured: Through study completion, an average of 1 year
Specific system placement procedure related adverse events
Device Implant
Measured: Through study completion, an average of 1 year
Lead(s) dislodgement requiring repositioning or cessation of CRT
Chest xray, device interrogation
Measured: Through study completion, an average of 1 year
Cardiac tamponade requiring intervention
Device Implant
Measured: Through study completion, an average of 1 year
Ventricular Arrhythmias
Device interrogation
Measured: 6 months, 12 months
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.
- First posted29 Jun 2018
- Study start28 Apr 2016 (estimated)
- Primary completion28 Apr 2019 (estimated)
- Study completion22 Jul 2019
Why it stopped: No patients enrolled; Executive Committee Decision;Feasibility of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure，CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jaimie Manlucu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaimie Manlucu, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Jaimie Manlucu, MD FRCPC, Principal investigator, Schulich School of Medicine, Western University, London Health Sciences Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LV Endocardial CRT for Patients With Intermediate QRS Width
- ClinicalTrials.gov ID
- NCT03573427
- Acronym / sponsor ID
- EndoCRT / V27Mar17
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients enrolled; Executive Committee Decision;Feasibility of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jaimie ManlucuUniversity, hospital or other
- Study start
- 28 Apr 2016 (estimated)
- Primary completion
- 28 Apr 2019 (estimated)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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%
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-atrial septal placement LV lead for CRT | Device | – |
Primary outcome
LV end-systolic volume
Time frame: Change from Baseline measure to 6 months
Echocardiogram
LVEF improvement
Time frame: Change from Baseline measure to 6 months
Echocardiogram
6 secondary outcomes
Thromboembolic Events
Time frame: Through study completion, an average of 1 year
Specific system placement procedure related adverse events
Time frame: Through study completion, an average of 1 year
Lead(s) dislodgement requiring repositioning or cessation of CRT
Time frame: Through study completion, an average of 1 year
Cardiac tamponade requiring intervention
Time frame: Through study completion, an average of 1 year
Ventricular Arrhythmias
Time frame: 6 months, 12 months
Mitral Regurgitation
Time frame: Baseline, 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaimie Manlucu, MD FRCPC principal investigator
Schulich School of Medicine, Western University, London Health Sciences Centre
8 sites in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 26 Oct 2026.