Heart Failure, Left Ventricular Dysfunction Clinical Trial
— RAFT-LVendoOfficial title:
Resynchronization for Ambulatory Heart Failure Trial - LV Endocardial
| NCT number | NCT02757976 |
| Other study ID # | 252410 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 8, 2018 |
| Est. completion date | June 20, 2019 |
| Verified date | September 2020 |
| Source | Lawson Health Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This trial will compare two strategies for patients with Heart Failure, Left Ventricular systolic dysfunction, and intermediate QRS durations. The control group is conventional CRT. The experimental group is LVendo CRT
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | June 20, 2019 |
| Est. primary completion date | June 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with NYHA Class II or III or ambulatory IV 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 durations more than or equal to 120 ms, but less than 150 ms - Patients are able to receive chronic oral anticoagulation - Patients with pacemaker or ICD that meet the above criteria may be upgraded to CRT-D or CRT-P Exclusion Criteria: - Planned Atrial Fibrillation Ablation within 12 months - Patients with mitral or tricuspid prosthetic valve that precludes the placement of an LV lead transvenously or trans-septally - Patients with RBBB - Patients with LV thrombus - 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 - Expected to undergo cardiac transplantation within one year (status I) - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Libin Cardiovascular Institute | Calgary | Alberta |
| Canada | Queen Elizabeth II Health Science | Halifax | Nova Scotia |
| Canada | London Health Science Centre | London | Ontario |
| Canada | McGill University Health Centre | Montréal | Quebec |
| Canada | Montreal Heart Institute | Montréal | Quebec |
| Canada | Royal Columbia Hospital | New Westminster | British Columbia |
| Canada | University of Ottawa Heart Institute | Ottawa | Ontario |
| Canada | Institut Univ.cardiologie/pneumologie de Québec | Quebec City | Quebec |
| Canada | CHUS Le Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
| Canada | St. Michael Hospital | Toronto | Ontario |
| Canada | Vancouver General Hospital | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Lawson Health Research Institute | Medtronic |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Thromboembolic Events Investigator deemed to be directly related to the therapy | Safety | Baseline to 12 months | |
| Other | Safety: LVendo CRT: specific system placement procedure related adverse events | Safety | Baseline to 12 months | |
| Other | Safety:Pocket infection requiring extending hospitalization > 24 hours or requiring surgical intervention | Baseline to 12 months | ||
| Other | Safety:Lead(s) dislodgement requiring repositioning or cessation of CRT | Baseline to 12 months | ||
| Other | Safety:Cardiac tamponade requiring intervention | Baseline to 12 months | ||
| Other | Safety:Phrenic nerve stimulation | Baseline to 12 months | ||
| Primary | Assessment of LVESVi | LV reverse remodeling as measured by the difference of LVESVi on echocardiography (echo) | Baseline to 6 months & 12 months | |
| Secondary | Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation. | Baseline to 6 months & 12 months | ||
| Secondary | NT-proBNP measurement | Baseline to 6 months & 12 months | ||
| Secondary | 6 Minute Hall Walk Distance | Baseline to 6 months & 12 months | ||
| Secondary | Quality of Life Measure | EQ5D-5L & Minnesota Living with HF | Baseline to 6 months & 12 months | |
| Secondary | Mortality | Baseline to 6 months & 12 months | ||
| Secondary | Heart Failure Admissions | Baseline to 6 months & 12 months | ||
| Secondary | Reduction of LVEF | Baseline to 6 months & 12 months |