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

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init