Francis D. Pagani, M.D., Ph.D. - Research

Harefield Recovery Protocol (HARPS) Study

A Non-Randomized, Open Label, Multi-Center Evaluation study

Co-Principal Investigators: Francis D. Pagani, MD, PhD, Keith Aaronson, MD

Funding: Thoratec and University of Michigan

The purpose of this study is to evaluate patients with refactory chronic heart failure by treatment with combination of left Ventricular assist device (LVAD), drugs to induce maximal reverse remodeling and the use of Clenbuterol.

The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation or Implantation of Left Ventricular Assist Devices

A prospective, multi-center, observational study

Investigators: Francis D. Pagani, MD, PhD, D. Bradley Dyke, MD

Funding: National Heart, Lung, and Blood Institute/National Institutes of Health

The primary purpose of this study is to characterize the timing and the activation sites of the clotting cascade in end stage heart failure patients who undergo LVAD implantation.

The Epidemiology of Ventricular Assist Device-Related Infections

A prospective, multi-center, observational study

Investigators: Francis D. Pagani, MD, PhD, D. Bradley Dyke, MD

Funding: National Heart, Lung, and Blood Institute/National Institutes of Health

The goals of this study is are to develop a better understanding of the pathogenesis and epidemiology of Staphylococcus aureus and epidermidis-VAD infections as well as to develop a set of criteria that can be used to help diagnose the presence or absence of a VAD-related infection.

The SynCardia CardioWest Temporary Total Artificial Heart (TAH-t) Postmarket Surveillance Study

A prospective, multi-center, observational, post-marketing surveillance study

Investigators: Francis D. Pagani, MD, PhD

Funding: SynCardia Systems, Inc.

The temporary Total Artificial Heart (TAH-t) created by SynCardia Systems, Inc. was approved by the Food and Drug Administration in 2004 after a 9 year clinical trial. It is currently commercially available for patients with heart failure that are awaiting a heart transplant. The study will look at the outcomes of patients receiving the TAH-t as part of their routine care for their heart failure.

INTERMACS: Interagency Registry for Mechanically Assisted Circulatory Support

A prospective, multi-center, observational registry

Investigators: Francis D. Pagani, MD, PhD, Eric J. Devaney, MD

Funding: National Heart, Lung, and Blood Institute, National Institutes of Health, and the Department of Health and Human Services.

INTERMACS is a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung, and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and drug Administration (FDA), clinicians, scientists and industry representatives. The fundamental goal of this registry is to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with advanced heart failure.

Clinical Investigation of the DeBakey VAD with Comparison to a Performance Goal to Establish Safety and Effectiveness of the Device as a Left Ventricular Support in Patients Awaiting Cardiac Transplantation

A prospective, multi-center, single-arm study

Investigators: Francis D. Pagani, MD, PhD, Eric J. Devaney, MD, Richard G. Ohye, MD, Himanshu Patel, MD, and Keith Aaronson, MD

Funding: MicroMed Technology, Inc.

The purpose of this study is to evaluate the effectiveness and safety of the DeBakey VAD¨ left ventricular support device in providing circulatory support as a bridge to cardiac transplant in patients, who are at risk of imminent death from non-reversible left ventricular failure.

The HeartMate II LVAS Pivotal Study

A prospective, multi-center study

Investigators: Francis D. Pagani, MD, PhD, Keith Aaronson, MD, D. Bradley Dyke, MD, Angela Freymuth Caveney, PhD, Eric J. Devaney, MD, and Jonathan Haft, MD

Funding: Thoratec Corporation

The goals of this study are to determine the safety and efficacy of the HMII as 1) a bridge to transplant in end-stage heart failure patients who are listed for cardiac transplant but at imminent risk of dying and 2) destination therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.

A Phase I Open Label Pilot Study to Obtain Tissue for Histological Analysis After Application of Anginera in Adults with a Left Ventricular Assist Device as a Bridge to Transplant

A prospective, multi-center, randomized, open-label, within-patient design study

Investigators: Francis D. Pagani, MD, PhD, Keith Aaronson, MD

Funding: Theregen, Inc.

The objectives of this study are to analyze cardiac tissue obtained after application of Anginera to adults with an LVAD as a bridge to transplant and to evaluate the safety of Anginera.

Heart Transplantation and Mechanical Circulatory Support Device Database

A prospective, observational registry

Investigators: Francis D. Pagani, MD, PhD, Keith Aaronson, MD

Funding: NA

The purpose of this registry is to collect data on heart transplant patients and those with a mechanical assist device as support for heart failure.