Feature | January 18, 2013

CardioKinetix Initiates Landmark Study of First-of-Its-Kind Treatment for Heart Failure in the United States

Randomized multicenter PARACHUTE IV clinical trial to compare minimally invasive device to optimal medical therapy

CardioKinetics PARACHUTE IV Clinical Trial Heart Failure Treatments

January 18, 2013 — CardioKinetix Inc. announced the enrollment of the first patients in PARACHUTE IV, the randomized pivotal U.S. clinical trial of the minimally invasive Parachute Ventricular Partitioning Device for the treatment of heart failure.

PARACHUTE IV is a multi-center pivotal trial designed to evaluate the PARACHUTE implant vs. optimal medical therapy (randomized 1:1) in approximately 500 patients with ischemic heart failure at up to 65 centers. The event-driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include functional outcomes, quality of life and hemodynamic measures by echocardiography.

The first implant with the Parachute device was performed by David Mego, M.D., assistant medical director at Arkansas Heart Hospital in Little Rock, Ark., who treated a 39-year-old female with NYHA class III heart failure referred by Carl Leding, M.D., director of the Congestive Heart Failure Clinic at Arkansas Heart Hospital.

Marco Costa, M.D., Ph.D., director of the Interventional Cardiovascular Center and the Research and Innovation Center at the Harrington Heart and Vascular Institute at Case Western Reserve University and co-principal investigator of the trial, said, “I am thrilled to be pioneering this exciting therapy in the United States, where there is a significant need for better treatments for this heart failure patient population.”

“Many patients who have had a heart attack experience an extremely poor quality of life due to the debilitating symptoms of heart failure, including shortness of breath, fatigue, lack of appetite, impaired thinking and increased heart rate. A classic example is the patient just treated at Arkansas Heart Hospital, where the patient experienced a heart attack less than two years ago and now struggles with simple things like dressing, cooking or playing outside with her son because of shortness of breath and extreme fatigue,” said William T. Abraham, M.D., the co-principal investigator of the trial and director of the Division of Cardiovascular Medicine and professor of internal medicine, physiology and cell biology at The Ohio State University Medical Center. “In October, three-year data on the initial patients treated with Parachute were presented at the TCT Conference by Costa. These strong and encouraging results provide confidence to initiate a landmark randomized, pivotal trial where a positive outcome will establish this technology as a primary therapy option for the treatment of ischemic heart failure patients.”

The Parachute device offers the first minimally invasive catheter-based treatment to partition the coronary muscle damaged by a heart attack. The treatment excludes the non-functional heart segment from the healthy, functional segment to decrease the overall volume of the left ventricle and restore its geometry and function.

“This initiation of the U.S. randomized pivotal study is a major milestone for CardioKinetix,” said Maria Sainz, president and CEO of CardioKinetix. “We are excited about the opportunity before us to make a major positive impact for patients with heart failure, and we believe that we have partnered with the right heart failure physicians and interventional cardiologists to enroll this trial quickly.”

For more information: www.cardiokinetix.com.

Related Content

News | Cardiac Resynchronization Therapy Devices (CRT)| September 03, 2015
Sorin Group announced the start of patient enrollment in its TRIUMPH-CRT clinical trial in Europe.
CeRtiTuDe cohort study, cardiac resynchronization therapy, CRT-D, CRT-P, ESC 2015
News | Cardiac Resynchronization Therapy Devices (CRT)| September 03, 2015
Most patients with a cardiac resynchronization therapy (CRT) pacemaker would not benefit from the addition of a...
FFR-CT, HeartFlow, PLATFORM trial, ESC 2015, ICA, fractional flow reserve, computed tomography

Image courtesy of HeartFlow Inc.

Feature | FFR Catheters| September 03, 2015
Results of the PLATFORM trial indicate fractional flow reserve computed tomography (FFR-CT) can obviate the need for...
News | Structural Heart| September 02, 2015
An investigational material known as Bioabsorbable Cardiac Matrix (BCM), designed to prevent cardiac remodeling in...
Valtech, cardioband, transcatheter mitral annuloplasty

Valtech's Cardioband transcatheter mitral annuloplasty system in development. It is uses a series of corkscrew anchors, similar to those used on EP implantable device leads, to install the annuloplasty ring to reshape the valve for improved leaflet coaptation.

Feature | Structural Heart| September 02, 2015
September 2, 2015 — HeartWare International Inc.
acute ischemic stroke, larger thrombi retrieval, improved neurological recovery, ESC 2015, MR CLEAN trial, sub-study
Feature | Thrombectomy Devices| September 02, 2015
Retrieval of larger thrombi during intra-arterial treatment (IAT) is associated with improved neurological recovery...
DOPPLER-CIP trial, ESC 2015, heart failure, predictor, small left ventricle, University of Leuven
Feature | Heart Failure| September 02, 2015
Findings presented at the European Society of Cardiology (ESC) Congress 2015 indicate that a small left ventricle with...
chest pain, triage, emergency department, new rapid assay, Dirk Westermann, BACC study, ESC 2015
News | Blood Testing| September 02, 2015
Emergency department patients with chest pain suggestive of acute myocardial infarction (AMI) can be triaged more...
Medtronic, OPTILINK, OptiVol, ICD, pulmonary congestion, ESC 2015
Feature | Heart Failure| September 01, 2015
Automated alerts for excess fluid accumulation in the lungs did not improve outcomes for heart failure patients with...
News | Atrial Fibrillation| September 01, 2015
The first-ever two-year outcomes from the Global Anticoagulant Registry in the Field - Atrial Fibrillation (GARFIELD-AF...
Overlay Init