News | Heart Failure | October 17, 2017

First Patient Enrolled in U.S. Arm of ALIVE Pivotal Heart Failure Trial

Trial will implant BioVentrix’s Revivent system in 120 patients to assess safety and efficacy of transcatheter heart failure treatment

First Patient Enrolled in U.S. Arm of ALIVE Pivotal Heart Failure Trial

October 17, 2017 — BioVentrix Inc. recently announced enrollment of the first patient in the U.S. arm of the ALIVE pivotal clinical trial. The trial is designed to demonstrate the safety and effectiveness of the Revivent TC TransCatheter Ventricular Enhancement System, a hybrid closed-chest procedure to treat patients suffering from heart failure symptoms related to cardiomyopathy. BioVentrix previously received investigational device exemption (IDE) approval for the study from the U.S. Food and Drug Administration (FDA).

The Less Invasive Ventricular Enhancement (LIVE) procedure was performed at the University of Pittsburgh Medical Center (UPMC) Heart and Vascular Institute by interventional cardiologist Catalin Toma, M.D., and cardiothoracic surgeon Christopher Sciortino, M.D. The device was successfully implanted with three micro-anchor pairs in a 42-year-old female patient suffering from ischemic heart failure. 

"UPMC remains at the forefront of implementing promising less invasive therapies to address the need for better heart failure treatment. We are pleased to be the first U.S. center to implant the Revivent TC System as part of the ALIVE clinical trial. The procedure aims to reshape the left ventricle, decrease the left ventricular end systolic volume index (LVESVI), and increase the ejection fraction (EF). The patient was discharged shortly after the procedure and is recovering well," said Toma.

"The LIVE procedure is less invasive and less traumatic than conventional surgical reconstruction. It expands the patient population that can be treated by reducing the procedural risk. The patient was able to undergo this procedure without having to perform a sternotomy or employ cardiopulmonary bypass," said Sciortino.

The ALIVE trial plans to enroll 120 patients at up to 20 sites in the U.S. and U.K. with a primary endpoint analysis at one year. The trial endpoints include positive effects on volume reduction, ejection fraction, quality of life (QOL), New York Heart Association (NYHA) Class, six-minute walk test and rehospitalization. Readmission rates following heart failure hospitalization remain high using standard therapies, with ≥ 50 percent of patients readmitted to the hospital within six months of discharge. Left ventricular volume reduction has been shown to significantly impact short and long-term survival rates.1 Annually, over 1 million patients are hospitalized with a primary diagnosis of heart failure, accounting for a total Medicare expenditure exceeding $17 billion.2

The Revivent TC System is approved for sale in Europe; it is not approved for sale in the United States.

Watch the VIDEO "How To Implant the Transcatheter Revivent TC Left Ventricular Remodeling System for Heart Failure"

For more information: www.bioventrix.com

References

1. White, HD, et al; Left ventricular end-systolic volume as the major determinant of survival after recovery from myocardial infarction. Circulation; 1987 Jul;76 (1):44-51.

2. Desai et al., Rehospitalization for heart failure. Circulation. 24 July 2012 (126:501-506).

Related Content

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating
Overlay Init