News | March 20, 2009

Trial of CRT Device Use in Heart Failure Patients with Milder Symptoms Completes Enrollment

March 19, 2009 – The enrollment phase of the RAFT clinical trial (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial) is complete, announced Medtronic Inc.
The trial studies the impact of cardiac resynchronization therapy (CRT) in mildly symptomatic heart failure patients, or those at risk of worsening heart failure, but not currently indicated under medical guidelines to receive treatment with the device.
“This study is important to guide therapy for heart failure patients with milder heart failure symptoms who have a dilated heart and poor heart function. These patients have a tendency to develop worsening symptoms, to require hospitalization, and they may die prematurely. This study will determine if cardiac resynchronization therapy, when used earlier in the disease, can delay or prevent the progression of heart failure,” said Anthony Tang, M.D., RAFT Nominated Principal Investigator and Adjunct Professor of Medicine, University of Ottawa.
CRT is a proven treatment for some patients with moderate to severe heart failure (New York Heart Association, or NYHA Class III and ambulatory Class IV) that improves the heart’s pumping efficiency, may help to reduce heart failure symptoms as well as hospitalizations and may improve quality of life and reduce mortality. The RAFT trial is one of several clinical trials underway to determine whether patients with mild or fewer symptoms (NYHA Class II) also may benefit from cardiac resynchronization therapy.
RAFT is a double-blinded, randomized, controlled trial led by the University of Ottawa Heart Institute and jointly supported by a peer-reviewed grant from Medtronic and the Canadian Institutes of Health Research (CIHR). It involves 1,800 patients with mild to moderate heart failure (NYHA Class II and III), left ventricular ejection fraction (LVEF, a measure of the heart’s pumping effectiveness) less than or equal to 30 percent and QRS duration of greater than or equal to 120 milliseconds. Patients in the control group received either a single or dual chamber ICD; patients in the “experimental” arm received a cardiac resynchronization therapy-defibrillator. The primary outcome is a composite of total mortality and heart failure hospitalization; secondary outcomes include total mortality, cardiovascular mortality, sudden arrhythmic death, health related quality of life, and cost economics. Patients will be followed for a minimum of 18 months.
Similar studies to RAFT, using CRT devices in this patient population, are being conducted in the U. S. The use of CRT devices is limited by federal law for this indication.
For more information:

Related Content

Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Overlay Init