Early Feasibility and First-in-Human Studies to Be Highlighted at TCT 2016
NEW YORK – October 24, 2016 – The 28th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium sponsored by the Cardiovascular Research Foundation (CRF) will feature a number of first-in-human and early feasibility trials that could impact future clinical practice. TCT, the world’s premier educational meeting specializing in interventional cardiovascular medicine, will take place October 29 – November 2, 2016 at the Walter E. Washington Convention Center in Washington, DC.
“Continual innovations in technology, products and services are vital to advancing the field of cardiology,” said Juan F. Granada, MD. Dr. Granada is the Executive Director and Chief Innovation Officer at the CRF Skirball Center for Innovation and a Co-Director of TCT. “From a septal occluder with a bioresorbable framework to the first new implantable device for advanced congestive heart failure in the United States in nearly twenty years, TCT will feature a wide variety of novel devices and treatments which could potentially impact how physicians treat patients with heart disease.”
Below are some of the many noteworthy innovation studies that will be presented at TCT 2016.
Structural Heart Disease Technologies
Prospective Single Center First-In-Human (FIH) Clinical Trial to Evaluate the Safety and Effectiveness of a Septal Occluder with Bioresorbable Framework in Patients with Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO)
This FIH trial investigated the safety and effectiveness of a new septal occluder with a bioresorbable framework (Carag Bioresorbable Septal Occluder) in the treatment of secundum ASD or PFO. Device closure of ASD or PFO is the standard of care in most countries. Current devices use a metal framework and occlusive patch material. Metal frameworks are reported to cause serious complications (e.g., erosion, perforation, and arrhythmia) as late as 10 years following implantation. A septal occluder with a bioresorbable framework has long been desired and until now, development of a clinically effective bioresorbable framework has been elusive. Researchers will report on the initial 14 subjects implanted at the CardioVascular Center in Frankfurt, Germany.
Presentation Time: Tuesday, November 1, 2016, 8:00 AM (Room 209, Level 2) – Interventional Innovation III: Early Feasibility and First in Human Studies
Percutaneous Suture Based PFO Closure with the NobleStitch EL Device: Initial Multicenter Clinical Experience
The NobleStitch EL PFO device is a CE approved technology which allows percutaneous PFO closure using only a simple polypropylene suture. This study reports the first multicenter data on the safety and efficacy of the device following commercial distribution. All patients undergoing closure with the device between May 2013 and July 2016 in six centers throughout Europe and Asia were included.
Presentation Time: Tuesday, November 1, 2016, 8:08 AM (Room 209, Level 2) – Interventional Innovation III: Early Feasibility and First in Human Studies
One-Year Outcomes from the Early Feasibility Study of the Harmony Trans-Catheter Pulmonary Valve
The Harmony Transcatheter Pulmonary Valve (HTPV) was designed for the native outflow tract of patients who require pulmonary valve replacement. This population comprises 75% of patients with congenital heart disease (CHD) with right ventricular outflow tract (RVOT) anomalies. Three sites enrolled patients in a non-randomized, prospective study utilizing this novel device. Procedural feasibility, safety, and TPV performance were assessed. One-year clinical outcomes will be presented.
Presentation Time: Tuesday, November 1, 2016, 8:21 AM (Room 209, Level 2) – Interventional Innovation III: Early Feasibility and First in Human Studies
Peripheral Vascular Disease Technologies
Simplicity Denervation System for Pulmonary Artery Denervation in Patients with Chronic Thromboembolic Pulmonary Hypertension: FIH Results
This first-in-man study evaluated the safety and effectiveness of the Simplicity denervation system in lowering pulmonary artery pressure in patients with chronic thromboembolic pulmonary hypertension.
A total of 12 patients were included. Functional capacity was determined by the 6MWT performed one week prior and three months following the procedure. The primary endpoints were improvement of functional capacity by the 6MWT and mean PAP at three months.
Presentation Time: Tuesday, November 1, 2016, 9:24 AM (Room 209, Level 2) – Interventional Innovation III: Early Feasibility and First in Human Studies
Emerging Coronary Technologies
Physiological Testing of Coronary Artery Stenosis by Computation of Invasive Coronary Angiography. The Wire-Free Functional Imaging (WIFI-II) Study
WIFI-II is the first prospective, adequately powered study designed to evaluate the diagnostic performance of quantitative flow ratio (QFR), a novel rapid approach for the computation of fractional flow reserve (FFR). QFR is based on 30-QCA and flow modeling with contrast flow velocity in diagnostic angiography. From December 2014 to May 2016, 360 consecutive patients with an indication for angiography based on CT-scans were included. The main endpoints were diagnostic performance assessed as the area under the receiver operating curve (AUC) and diagnostic accuracy with FFR ≤0.80 as a reference standard. The secondary endpoint was feasibility assessed as a fraction of conventional FFR measurements where a QFR value is computed.
Presentation Time: Tuesday, November 1, 2016, 10:06 AM (Room 209, Level 2) – Interventional Innovation III: Early Feasibility and First in Human Studies
FFRangio: Image-Based FFR During Coronary Catheterization
This double-blind study evaluated the diagnostic performance (accuracy and reproducibility) of angiography-based FFR (FFRangio) in comparison with invasive FFR. FFRangio is a novel technology providing a functional angiography mapping of the coronary arteries in 3D. It is based on a rapid flow analysis of a dynamically-derived lumped model using routine angiograms and aortic pressure. All lesions indicated for invasive FFR measurement were analyzed by FFRangio from multiple views of a regular angiogram. The three dimensional shape of the vessels was used to initiate the flow analysis. FFRangio was compared to invasive FFR at the exact location of the sensor. To ensure complete blinding, invasive FFRs were locked in a database exclusively controlled by an independent CRO. The FFRangio calculations were performed offline in a remote location by two operators not present in the catheterization laboratory and totally blinded to each other and to invasive FFR. Then, the FFRangio results were sent to the CRO for comparison.
Presentation Time: Tuesday, November 1, 2016, 10:14 AM (Room 209, Level 2) – Interventional Innovation III: Early Feasibility and First in Human Studies
Interventional Heart Failure and Hypertension
First Report of the NuPulseCV iVAS for Treating Advanced CHF
The NuPulseCV iVAS is designed to be a minimally invasive, ambulatory, long-term counterpulsation system for patients suffering from advanced congestive heart failure. Compared to continuous flow LVADs, the iVAS has the potential to expand therapy to less sick patients due to its expected safer complication profile. The device does not need access to the heart via thoracotomy or sternotomy making it forward compatible as a bridge to transplant, recovery or extending medical therapy. Ten patients were enrolled in a non-randomized and observational FDA-approved First-In-Human IDE trial at the University of Chicago Medicine. For these initial patients, the iVAS was utilized in-hospital as bridge-to transplant. The primary outcome was survival or transplant at 30 days.
Presentation Time: Tuesday, November 1, 2016, 11:17 AM (Room 209, Level 2) – Interventional Innovation III: Early Feasibility and First in Human Studies
Neuromodulation for the Treatment of Resistant Hypertension: First-In-Human Evaluation of an Implanted Median Nerve Stimulator
This first-in-human study evaluated a fully-implantable median nerve stimulator for resistant hypertension. A multi-center, prospective, blinded, sham-controlled, 1:1 randomized, feasibility and safety study was conducted in New Zealand, Taiwan, and Canada. Subjects with resistant hypertension were implanted with a coin-sized, programmable, peripheral neurostimulator subcutaneously in both forearms, overlying the median nerves. One month after implantation, subjects were randomly allocated to active (treatment) or delayed activation (control) groups. The control group had device activation after six months. Once activated, the devices were programmed to stimulate for 30 minutes each week. The study was powered for the primary efficacy endpoint of change in automated office systolic BP from baseline to six months post-activation. Secondary endpoints included device safety and the between-group comparison in BP.
Presentation Time: Tuesday, November 1, 2016, 11:45 AM (Room 209, Level 2) – Interventional Innovation III: Early Feasibility and First in Human Studies
Dr. Juan Granada will be available to speak to the media about these studies and their clinical impact during TCT. He is theExecutive Director and Chief Innovation Officer of the CRF Skirball Center for Innovation, a Co-Director of TCT, and Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons. If you would like to schedule an interview, please contact Judy Romero (email@example.com) or a staff member in the onsite press room.