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

Videos | Cath Lab| January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab| January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab| November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab| November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab| November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab| November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Three-Year Quality of Life Improvements Similar for PCI and CABG in Left Main Disease
News | Cath Lab| October 30, 2017
October 30, 2017 — New study results from the EXCEL trial comparing the quality of life (QoL) of patients with left m
Corindus Evaluates Incorporating HeartFlow Technology With CorPath GRX System
Technology | Cath Lab| October 26, 2017
Corindus Vascular Robotics Inc. announced that it will incorporate the HeartFlow FFRct (fractional flow reserve-...
Shockwave Medical Announces $35 Million in New Financing
News | Cath Lab| October 24, 2017
October 24, 2017 — Shockwave Medical reported $35 million in new financing, an extension of the company’s previously
Overlay Init