Heart and Vascular Clinical Trials

Our Heart and Vascular Center of Excellence has a thriving research program including clinical and basic cardiovascular research. Member hospitals are actively engaged in every aspect of clinical cardiovascular research through their partnerships with major academic institutions, and pharmaceutical and device companies. Because of this commitment to research, our patients have access to the very latest therapies, devices and interventional techniques, often before these new innovations are released to nonacademic cardiac centers.

Areas of particular interest include novel revascularization approaches for the coronary and peripheral arteries, advanced electrophysiological ablation technologies, cardiorenal syndromes, resistant hypertension, and new therapies for atherosclerosis and heart failure. Our translational research involves basic vascular immunobiology, protein biomarkers, and novel non-invasive imaging. We publish over 100 peer-reviewed manuscripts annually and hold the co-editorship of Reviews in Cardiovascular Medicine, the nation’s most widely read review journal among practicing cardiologists. In addition, we offer a thriving Cardiology fellowship program.

Evolut Low Risk Trial: Novel Artificial Heart Valve In Low-Risk Aortic Stenosis Trial

The Cardiovascular Research Department at Ascension St. John Hospital is currently enrolling patients into Medtronic’s Low Risk Trial, a clinical study evaluating the safety and effectiveness of transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who are at a low risk for surgical aortic valve replacement (SAVR). A TAVR is a minimally-invasive procedure that replaces the diseased valve as an alternative treatment option to open-heart surgery. The replacement valve is mounted onto a catheter that enters the body through a large artery, typically the femoral artery, and is delivered to the heart where the device expands and replaces the diseased aortic valve.

Post-procedure TAVR patients are reported to have less pain, decreased risks of infection, and faster recovery times than those who undergo surgery. To date, the TAVR system is only commercially available for patients with severe aortic stenosis who are considered an intermediate or high risk for surgical valve replacement. Patients with severe aortic stenosis who are at a low surgical mortality risk may be eligible to enroll in the Low Risk Trial and should contact their doctor to discuss their treatment options.

To refer a patient or for more information, contact Renee Bess, BS, CCRP, at 313-343-4811 or e-mail renee.bess@ascension.org.

Learn more about the Evolut Low Risk TAVR Trial

Nanostim LEADLESS II Pacemaker Trial

The future of pacemaker technology in Southeast Michigan took a giant leap forward in August 2014, when the Electrophysiology Team at Ascension St. John Hospital became the first in the area to implant the Nanostim, a wireless, non-surgical cardiac pacemaker placed directly into the right ventricle of the heart. The first patient to receive the device in Southeast Michigan was an 84-year-old man from Clinton Township. Pacemakers are important for treat abnormal heart rhythms (arrhythmias), and providing a non-surgical pacemaker option allows for increased eligibility amongst arrhythmia patients.

“Nanostim is one of the most exciting advances yet in pacing technology,” says Sohail Hassan, MD, director of Electrophysiology, Ascension St. John Hospital. “It has the potential to transform how heart rhythm patients are treated. Within seven months of the first Nanostim implant in the US, we were able to bring it to patients locally.”

Currently, Nanostim is only available in the U.S. through the LEADLESS II trial, an international clinical study to evaluate the safety and effectiveness of the pacemaker. Ascension is one of 50 centers participating in the LEADLESS II pacemaker trial nationwide.

MagnaSafe Registry

Pacemakers and defibrillators, implanted in the chest or abdomen to regulate abnormal or irregular heart rhythms, are essential for many individuals. But until recently, having one of these devices meant being ineligible for an important diagnostic test – an MRI (magnetic resonance imaging). It was thought that the powerful magnetic and radiofrequency fields generated during imaging would damage or inhibit the device and cause discomfort or even harm to the patient. Researchers at Ascension Providence Hospital, Southfield Campus are leading the way to show that MRI is safe for patients with pacemakers and defibrillators and that they too, can benefit from this advanced diagnostic tool.

“We are the number one recruiting center for the MagnaSafe trial,” says Dr. Christian Machado, MD, electrophysiology specialist at Ascension. “There are 60 centers nationwide recruiting, and more than 1,500 patients have enrolled. We have 400 of those – more than one-quarter of the total. The study goal is to enroll 2,500 patients.”

Learn more about the MagnaSafe Registry

SPYRAL HTN Global Clinical Trial Program

Ascension Providence Hospital, Southfield Campus is participating in two new global clinical trials investigating the effect of renal denervation with the investigational Symplicity Spyral™ catheter and Symplicity G3™ radiofrequency (RF) generator. Renal denervation is a minimally invasive, catheter-based procedure that may potentially calm the activity of nerves within the arteries leading to the kidneys.

These nerves are part of the sympathetic nervous system, which helps the body control blood pressure. In people with hypertension, the renal nerves are hyperactive, raising blood pressure and contributing to heart, kidney and blood vessel damage. The two separate trials enrolling at Ascension Providence Hospital are investigating the effect of renal denervation on high blood pressure in patients who are and who are not taking medications to lower their blood pressure.

Learn more about SPYRAL HTN Global Clinical Trial Program.

Contact Us

Research Department, Ascension Providence Hospital
David Svinarich, PhD, Director of Research
248-849-3997

Cardiology Research Department, Ascension St. John Hospital
313-343-7532

Cardiology Research, Ascension Macomb-Oakland Hospital
586-576-4068

Learn more about SPYRAL HTN Global Clinical Trial Program.

Medical Directors/Chiefs

Shukri David, MD, FACC
Medical Director, Ascension Southeast Michigan Cardiovascular Network
Chief, Cardiology, Ascension Providence Hospital, Southfield Campus

248-849-2842

Thomas LaLonde, MD, FACC
Chief, Cardiology, Ascension St. John Hospital

313-343-3935

Lingareddy Devireddy, MD, FACC
Medical Director, Cardiovascular Services, Ascension Macomb-Oakland Hospital

586-573-5412