Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function

Resynchronization for Ambulatory Heart Failure Trial in Patients With Preserved LV Function (RAFT-Preserved)

This trial will compare two management strategies for HF patients with preserved LV function in sinus rhythm and LBBB. The control group will be treated with practice guideline optimal medical therapy for HF. The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT.

This is a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (PROBE) design.

The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT.

The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive Conduction System(CS)-CRT.

The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT

The co-primary outcome measure is quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score. The MLHFQ consists of 21 questions answered on a 0-5 likert scale, with higher scores indicating a stronger impact of heart failure on QoL.

Ventricular arrhythmia burden determined by the device capture of arrhythmias and adjudication by a device review committee blinded to patient's treatment allocation

The secondary outcome measure is Ventricular arrhythmia burden determined by the device as measured at 6 months.

The secondary outcome measure is LV reverse remodeling as measured by LVESVi on echocardiography at 6 months.

Inclusion Criteria: Patients with NYHA class II-IVa HF symptoms and are on diuretic therapy LVEF > 35% (stratify by LVEF 36-49% and LVEF ≥ 50%), and recovered LVEF (previously LVEF ≤ 35%, but improved to LVEF > 35% with medical therapy) Patients with LVEF ≥ 50% must also have either left atrial enlargement (any of the following: LA diameter ≥3.8 cm, LA length ≥5.0 cm, LA volume ≥55 ml, LA volume index (LAVi) ≥29 mL/m2) or LV hypertrophy (LV mass index (LVMI) ≥115 g/m2 for males and ≥ 95g/m2 for females) LBBB and QRS duration ≥ 140 msec. for men or ≥ 130 msec. for women, and with mid-QRS notching or slurring in ≥ 2 leads Patients may have permanent RV pacing with a QRS duration ≥180ms Patients may have permanent atrial fibrillation with good rate control defined as a resting heart rate of ≤80 bpm at rest and ≤110 bpm with 6-minute walk test NT-proBNP ≥ 600 pg/ml on stable medical therapy without previous heart failure hospitalization in the last 12 months, or ≥400 pg/ml on stable medical therapy if there was a heart failure hospitalization within the previous 12 months Appropriate pharmacological treatment of HF and co-morbidities. Stable diuretic and other HF medications for at least four weeks Exclusion Criteria: Serum creatinine >180 μmol/L; or estimated glomerular filtration rate [eGFR] ≤30 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease formula 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 TAVI < 3 months Restrictive, or reversible form of cardiomyopathy, cardiac amyloidosis Severe primary pulmonary disease such as cor pulmonale, primary pulmonary hypertension (may include secondary pulmonary hypertension, if mean pulmonary pressure is ≤ 70 mm Hg) 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 Patients who are pregnant/intend to get pregnant Those unable or unwilling to provide informed consent