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Sentara brings 1st minimally invasive treatment for aortic regurgitation to Virginia
Health System's participation in national clinical trial helped pave the way for new minimally invasive option
For decades, open-heart surgery was the only treatment option for people with severe aortic valve disease. Patients too sick to withstand major surgery often faced a steady decline in heart function.
That changed in the last decade with the introduction of transcatheter aortic valve replacement (TAVR), a minimally invasive procedure that allows interventional cardiologists and cardiac surgeons to replace diseased heart valves through the femoral artery. Sentara’s Structural Heart program has been at the forefront of TAVR innovation and research for the past 17 years.
Even so, a major treatment gap remained.
Patients with aortic regurgitation (also known as aortic insufficiency, where the valve leaks instead of narrowing) were often not candidates for traditional TAVR procedures. Unlike patients with aortic stenosis, these valves frequently lack the calcium needed to securely anchor conventional TAVR devices, leaving open-heart surgery as the only viable option for many high-risk patients.
Now, Sentara Health is helping close that gap.
Sentara Heart Hospital participated in the national ALIGN-AR clinical trial evaluating the JenaValve Trilogy Transcatheter Heart Valve System. It’s the first and only FDA-approved transcatheter valve specifically designed to treat aortic regurgitation in patients with non-calcified valves.
The trial began at Sentara in March 2022. Sentara was one of only 30 sites nationwide enrolled to participate, alongside major academic and cardiovascular centers in Washington, D.C., Baltimore, and Charleston. During the clinical trial, the Sentara team completed 30 procedures and screened more than 100 patients.
The Trilogy valve received FDA approval in late March 2026.
The first two commercial cases at Sentara Heart Hospital were successfully performed on Monday, May 4 – making Sentara the first, and currently only, health system in Virginia offering the procedure.
“When we started the first TAVR program for aortic stenosis in 2011 and 2012, we were excited to offer minimally invasive therapy for aortic valve stenosis alongside some of the largest and most progressive institutions in the country,” said Deepak Talreja, M.D., clinical chief of cardiology and co-investigator for the ALIGN AR JenaValve trial. “Now, a decade later, with the JenaValve for aortic valve insufficiency, we have the technology to treat this next frontier.”
The Trilogy system was purpose-built for patients with symptomatic aortic regurgitation who do not have enough valve calcification to support traditional TAVR devices.
“The JenaValve Trilogy system was designed specifically for this anatomy,” said Matthew Summers, M.D., interventional cardiologist, program director of structural heart, and principal investigator for the ALIGN AR JenaValve trial. “For our patients, who previously had to choose between high-risk surgery or living with a progressively failing heart. It’s a genuine paradigm shift.”
Clinton Kemp, M.D., cardiothoracic surgeon and co-investigator for the ALIGN AR JenaValve trial, added, “This new technology offers patients a safer, less invasive treatment with faster recovery and a quicker return to daily life.”
Leaders within Sentara’s Structural Heart program say participation in groundbreaking clinical trials is central to the system’s mission and commitment to innovation.
“Being a clinical trial site for transformative technologies is part of how our heart team delivers on its mission,” said Dr. Kemp. “It means patients in Hampton Roads gain access to leading-edge therapies years before they are broadly available.”
He added that Sentara’s involvement in national trials positions the health system as both a regional and national leader in structural heart therapies.
“Centers like ours provided critical data that helped lead to FDA approval and widespread adoption of transcatheter valve therapies,” Dr. Kemp said. “It was a logical next step for us to participate in this trial.”
This experience will now allow the program to serve as a national training site for physicians learning the procedure.
“Our team feels incredibly fortunate to work in a system devoted to meeting the needs of patients in our region and beyond with novel device therapies that address major treatment gaps in structural heart disease,” said Dr. Summers.
Joshua Cohen, M.D., a structural heart imaging specialist, said the success reflects the strength of the entire multidisciplinary team.
“The culture is what makes a program capable of taking on first-in-region cases like these and delivering them at the highest level,” Dr. Cohen explained. “We have an incredible team providing interventional and structural heart cardiology, cardiac surgery, and advanced cardiac imaging at the highest levels of cardiovascular care.”
That changed in the last decade with the introduction of transcatheter aortic valve replacement (TAVR), a minimally invasive procedure that allows interventional cardiologists and cardiac surgeons to replace diseased heart valves through the femoral artery. Sentara’s Structural Heart program has been at the forefront of TAVR innovation and research for the past 17 years.
Even so, a major treatment gap remained.
Patients with aortic regurgitation (also known as aortic insufficiency, where the valve leaks instead of narrowing) were often not candidates for traditional TAVR procedures. Unlike patients with aortic stenosis, these valves frequently lack the calcium needed to securely anchor conventional TAVR devices, leaving open-heart surgery as the only viable option for many high-risk patients.
Now, Sentara Health is helping close that gap.
Sentara Heart Hospital participated in the national ALIGN-AR clinical trial evaluating the JenaValve Trilogy Transcatheter Heart Valve System. It’s the first and only FDA-approved transcatheter valve specifically designed to treat aortic regurgitation in patients with non-calcified valves.
The trial began at Sentara in March 2022. Sentara was one of only 30 sites nationwide enrolled to participate, alongside major academic and cardiovascular centers in Washington, D.C., Baltimore, and Charleston. During the clinical trial, the Sentara team completed 30 procedures and screened more than 100 patients.
The Trilogy valve received FDA approval in late March 2026.
The first two commercial cases at Sentara Heart Hospital were successfully performed on Monday, May 4 – making Sentara the first, and currently only, health system in Virginia offering the procedure.
“When we started the first TAVR program for aortic stenosis in 2011 and 2012, we were excited to offer minimally invasive therapy for aortic valve stenosis alongside some of the largest and most progressive institutions in the country,” said Deepak Talreja, M.D., clinical chief of cardiology and co-investigator for the ALIGN AR JenaValve trial. “Now, a decade later, with the JenaValve for aortic valve insufficiency, we have the technology to treat this next frontier.”
The Trilogy system was purpose-built for patients with symptomatic aortic regurgitation who do not have enough valve calcification to support traditional TAVR devices.
“The JenaValve Trilogy system was designed specifically for this anatomy,” said Matthew Summers, M.D., interventional cardiologist, program director of structural heart, and principal investigator for the ALIGN AR JenaValve trial. “For our patients, who previously had to choose between high-risk surgery or living with a progressively failing heart. It’s a genuine paradigm shift.”
Clinton Kemp, M.D., cardiothoracic surgeon and co-investigator for the ALIGN AR JenaValve trial, added, “This new technology offers patients a safer, less invasive treatment with faster recovery and a quicker return to daily life.”
Leaders within Sentara’s Structural Heart program say participation in groundbreaking clinical trials is central to the system’s mission and commitment to innovation.
“Being a clinical trial site for transformative technologies is part of how our heart team delivers on its mission,” said Dr. Kemp. “It means patients in Hampton Roads gain access to leading-edge therapies years before they are broadly available.”
He added that Sentara’s involvement in national trials positions the health system as both a regional and national leader in structural heart therapies.
“Centers like ours provided critical data that helped lead to FDA approval and widespread adoption of transcatheter valve therapies,” Dr. Kemp said. “It was a logical next step for us to participate in this trial.”
This experience will now allow the program to serve as a national training site for physicians learning the procedure.
“Our team feels incredibly fortunate to work in a system devoted to meeting the needs of patients in our region and beyond with novel device therapies that address major treatment gaps in structural heart disease,” said Dr. Summers.
Joshua Cohen, M.D., a structural heart imaging specialist, said the success reflects the strength of the entire multidisciplinary team.
“The culture is what makes a program capable of taking on first-in-region cases like these and delivering them at the highest level,” Dr. Cohen explained. “We have an incredible team providing interventional and structural heart cardiology, cardiac surgery, and advanced cardiac imaging at the highest levels of cardiovascular care.”
By: Jen Lewis