Resynchronization/defibrillation for Ambulatory Heart Failure Trial (RAFT)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

(Protocol p.10)
• NYHA Class II
• LV EF <= 30%
• Intrinsic QRS Complex Width >= 120 ms OR Paced QRS measurement >= 200 ms
• ICD indication for primary or secondary prevention (single or dual chamber system)
• Optimal heart failure pharmacological therapy
• Normal Sinus Rhythm OR
- Chronic persistent Atrial Tachyarrhythmia with resting Ventricular Heart Rate <= 60 bpm and 6 Minute Hall Walk Ventricular Heart Rate of <= 90 bpm OR
- Chronic persistent Atrial Tachyarrhythmia with resting Ventricular Heart Rate > 60 bpm and 6 Minute Hall Walk Ventricular Heart Rate of > 90 bpm and booked for Atrio-Ventricular Junction Ablation

Exclusion Criteria

(Protocol p.10-11)
• Intra-venous inotropic agent in the last 4 days
• Patients with a life expectancy of less than one year from non-cardiac cause
• Expected to undergo cardiac transplantation within one year (status I)
• Patients with an acute coronary syndrome including MI1 can be included if the patient has had a previous MI with LV dysfunction (LVEF <= 30% )
• In hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
• Uncorrected or uncorrectable primary valvular disease
• Restrictive, hypertrophic or reversible form of cardiomyopathy
• Severe primary pulmonary disease such as cor pulmonale
• Tricuspid prosthetic valve
• Patients with an existing ICD (Patients with an existing pacemaker may be included if the patients satisfies all other inclusion/exclusion criteria)
• Coronary revascularization (CABG3 or PCI4) < 1 month if previously determined LVEF > 30%
Patients with a more recent revascularization can be included if a previous determined LVEF was <= 30%
• Patients included in other clinical trial that will affect the objectives of this study
• History of noncompliance of medical therapy
• Unable or unwilling to provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is a composite of total mortality and heart failure<br /><br>hospitalization. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures include total mortality, cardiovascular mortality,<br /><br>sudden arrhythmic death, hospitalization, health related quality of life, and<br /><br>health economics. Other outcome measures: 6 minute hall walk distance, NYHA<br /><br>Class changes, development of new atrial fibrillation, and non-fatal<br /><br>ventricular tachycardia. </p><br>