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Considerable experience in clinical and pre-clinical settings with respect to the design and conduct of research, both regulated and non-regulated, in Europe and in the U.S. Strong organizational ability. Well versed with FDA regulatory requirements. Strong background in electronic systems and software for medical applications, especially the real-time acquisition and manipulation of low-level cardiac and neurophysiologic signals. Good understanding of both clinical applications and the clinical marketplace. Excellent speaking and writing skills. Strong relationships with thought leaders and practicing clinicians in cardiac electrophysiology.
EXPERIENCE: Consultant (3 years) Consulting for: Clinical study design and implementation for both regulated and unregulated trials; advised on OUS first-in-man trials; clinical operations; regulatory strategies; report authoring and presentation. Cardiac ablation systems: bench and pre-clinical modeling and testing. Implantable neurotim device pre-clinical and clinical testing. Vice President,
Clinical Affairs and Clinical Research (6 years) Responsible for design, implementation and management of international clinical, pre-clinical and non-regulated (EU post-market) research programs centered on product evaluation, basic research, product development, product enhancement and expanded indications. Hired and directed a group of in-house (4) and field clinical staff (4). Initiated, directed and completed CE-mark trial. Designed and conducted two US IDE Phase I trials. 510(k) approval for surgical cryoablation system. Also responsible for obtaining all necessary resources to fulfill duties including financial, personnel and physical. Responsible for publication/presentation of research results before the scientific and clinical communities. Responsible for implementing a continuing research program demonstrating product safety and efficacy for the medical user. Contributed on a regular basis to product design, clinical affairs and marketing activities. Manager/Director, Clinical Operations-US (1 year) Direction of clinical operations
for finalization of Manager of Clinical Operations-Europe (3 years) Designed, implemented, and
completed a 50-patient feasibility study of implantable atrial defibrillation
technology within European Community.
Later, developed and supported research centers for pre-clinical and
clinical testing; implemented EU clinical department including staffing,
support structure for clinical studies; hiring and training of in-house and
field staff. Developed and
supported EU studies and post-market centers for advanced research on product
improve Senior Field Clinical Engineer (2 years) Pacemaker clinical evaluations; ICD clinical evaluations. Senior Research Associate and Consultant (4 years) Designed and tested technology for implantable anti-arrhythmic drug pump; ICU bedside concept test system. Supervision of engineering staff. Consulting on ECG arrhythmia detection algorithm design and evaluation. Senior Staff Engineer (5 years) ECG algorithm design; developed tools for algorithm evaluation. Senior Scientific Associate (4 years) Develop Research Assistant (8 years) ECG algorithm design and development of tools for algorithm evaluation; data compression; manager of AHA Arrhythmia Database. EDUCATION:
Master of Science-Electrical
Engineering from Sever Institute, Washington University, St. Louis, Doctor of Philosophy-Psychology (Degree Candidate; NIH Fellowship Recipient) at Washington University, St. Louis, MO, included four years of research in developmental neurobiology; Bachelor of Arts in Psychology from North Carolina State University, Raleigh, NC , included 2 years of research in animal behavior and neurophysiology. Professional Societies: IEEE Institute for Electrical and Electronics Engineers AHA American Heart Association - Council on Clinical Cardiology RAPS Regulatory Affairs Professional Society PUBLICATIONS: Fifty-one publications: eight refereed, twenty-four abstracts, one book, remainder in technical publications; edited the yearly publication Computers in Cardiology for 15 years; 2 patents.
Ripley, K.L. and Provine, R.R. "Neural correlates of embryonic motility in the chick," BRAIN RESEARCH, 972; 45: pp. 127-134. Cox, Jr., J.R. and Ripley, K.L. "Compact digital coding of
electrocardiographic data," PROCEEDINGS OF THE SIXTH HAWAII
INTERNATIONAL CONFERENCE ON SYSTEM SCIENCES, Ripley, K.L.
and Arthur, R.M. "Evaluation and comparison of automatic arrhythmia
detectors," COMPUTERS IN CARDIOLOGY,
IEEE Computer Society, Ripley, K.L. and Cox, Jr., J.R. "A computer system for capturing
transient electrocardiographic data," COMPUTERS IN CARDIOLOGY,
IEEE Computer Society, Los Alamitos Oliver, G.C.,
Ripley, K.L., Miller, J.P. and Martin, T.F. "A critical review of
computer arrhythmia detectors." In COMPUTER ELECTROCARDIOGRAPHY: CURRENT STATUS AND CRITERIA (L. Pordy,
ed.) Futura, Oliver, G.C. and Ripley, K.L. "Automated detection and analysis of ventricular arrhythmias," PROCEEDINGS OF THE FIRST US-USSR SYMPOSIUM ON SUDDEN DEATH, Yalta, USSR, October 3-5,1977, DHEW Publication Number (NIH)78-1470. Cox, Jr., J.R., Bridger, D.A., Ripley, K.L. and
Zacher, R. "Computers in Medicine." In WHAT CAN BE AUTOMATED? THE COMPUTER SCIENCE AND ENGINEERING RESEARCH
STUDY, (B. Arden, ed.) MIT Press, Ritter, J.A., Thomas, Jr., L J. and Ripley,
K.L. "Argus RT: A microcomputer system for clinical arrhythmia
monitoring," COMPUTERS IN CARDIOLOGY, IEEE Computer Society, Ripley, K.L. and Oliver, G.C. "Development of an ECG database
for arrhythmia detector evaluation," COMPUTERS IN CARDIOLOGY,
IEEE Computer Society, Ripley, K.L., Geselowitz, D.B., and Oliver, G.C.
"The American Heart Association arrhythmia database: a progress
report." COMPUTERS IN CARDIOLOGY, IEEE Computer Society, Thomas, Jr., L.J., Cox, Jr., J.R.,
Hermes, R.E. and Ripley, K.L. "Evaluation of Performance" in
AMBULATORY ELECTROCARDIOGRAPHIC
RECORDING, (N.K. Wenger, M.B. Mock, Ripley, K.L. and Murray, A. INTRODUCTION TO AUTOMATED ARRHYTHMIA DETECTION, IEEE Computer Society, Los Alamitos, California, 1980. Ripley, K.L.,
Okkerse, RJ., Engelse, W.A.H., Vinke, R.V.H. and Zeelenberg, C.
"Implementation of Argus/2H at the Thoraxcentrurn," COMPUTERS IN CARDIOLOGY, IEEE Computer Society,
Zeelenberg, C., Ripley, K.L. and Okkerse, R.
"Equipment Specifications and Performance Criteria: Clinical
Evaluation", In LONG TERM AMBULATORY ELECTROCARDIOGRAPHY (J. Roelandt
and P.G. Hugenholtz, eds.) Martinus Nijhof, Mark, R.G. and Ripley, K.L. "Ambulatory
Monitoring: Real-Time versus Tape Scanning Systems," PROCEEDINGS OF THE FIRST WORKSHOP ON AMBULATORY MONITORING:
CARDIOVASCULAR SYSTEM AND ALLIED APPLICATIONS, Ripley, K.L. and Marchesi, C. "Automated Arrhythmia Detection," PROCEEDINGS OF THE INTERNATIONAL SYMPOSIUM ON APPLICATIONS OF COMPUTERS IN CARDIOLOGY, Menorca, Spain, North Holland Publishers, 1984. Arzbaecher, R., Bump, T., Ripley, K.L., Yurkonis,
C, Jenkins, J. and Noh, K. "Implantable Microprocessor-Based Devices for the Management of Arrhythmia,"
COMPUTERS IN CARDIOLOGY, IEEE Computer Society, 1988, pp 29-34. Bump, T.E., Ripley, K.L., Guezennec, A., and Arzbaecher, R. "The Effect of Drugs and Lead Maturation on Atrial Electrograms during Sinus Rhythm and Atrial Fibrillation," AMER. HEART J., 1989; 117(3): pp. 557-584. Ripley, K.L., Bump, T.E., and Arzbaecher, R.C., "Evaluation of Techniques for Recognition of Ventricular Arrhythmias by Implanted Devices," IEEE TRANS BIOMED ENG, l989; 36(6): pp. 616-624. Jadvar, H.,
Ripley, K.L., and Arzbaecher, R.C., "Power Spectral, Cepstral, and
Hartley Analyses of Intracardiac Electrograms for Detection of
Tachyarrhythmias," COMPUTERS IN CARDIOLOGY, IEEE Computer Society, 1989, pp. 175-178. Ripley, K.L.,
Bump, T.E., and Arzbaecher, R.C., "Detection and Distinction of Atrial
Arrhythmias from Bipolar Electrograms," PROCEEDINGS 1990 ENGIN
MED BIOL SOC ( Lévy, S., Ricard, P., Lau, C.-P., Lok, N.-S., Camm, A.J., Murgatroyd, F.D., Jordeans, L.J., Kappenberger, L.J., Brugada, P. and Ripley, K.L. “Multicenter Low Energy Transvenous Atria Defibrillation (XAD) Trial Results in Different Subsets of Atrial Fibrillation,” JACC, 1997; 29(4): pp. 750-755. Singer, Reek, S., Geller, J.C., Schildhaus, H.-U., Ripley,
K.L. and Klein, H., “Feasibility of Catheter Cryoablation in Tse, H.-F., Ripley, K.L., Lee, K.L.F., Siu, C.-W., Van Vleet, J.F., Pelkey, W.L. and Lau, C.-P., “Effects of Temporal Application Parameters on Lesion Dimensions During Transvenous Catheter Cryoablation,” J CARDIOVASC ELECTROPHYSIOLOGY, 2005; 16(2): pp. 1-4. Ripley, K., Gage, A., Van Vleet, J., Lau, C.-P., Olsen, D. and Tse, H.-F., “Time Course of Esophageal Lesions after Catheter Ablation with Cryothermal and Radiofrequency Ablation: Implication for Atrio-Esophageal Fistula Formation after Catheter Ablation for Atrial Fibrillation,” J CARDIOVASC ELECTROPHYSIOL, 2007; 18(6) pp 242-646. Abstracts: Ripley, K.L., Nolle, F.M., Thomas, Jr., LJ. and Oliver, G.C. "Marked increases in frequency of premature ventricular contractions at nine months following myocardial infarction," CIRCULATION, 1975; 52(4): pp. 11-94. Ripley, K.L.
and Comerchero, H. "Introduction to automated arrhythmia
detection," MEDICAL TECHNOLOGY SYMPOSIUM, Ripley, K.L. and Lecksell, JJR. "A system for
automated evaluation of arrhythmia detection algorithms," PROCEEDINGS OF THE 19TH ANNUAL AAMI MEETING, Ripley, K.L., Murray, A. and Mark, R.G. "Automated Arrhythmia Detection" (tutorial), FINAL PROGRAM OF THE 19TH ANNUAL AAMI MEETING, Arlington, VA, Association for the Advancement of Medical Instrumentation, 1984. Ripley, K.L.
"A critical review of modem ambulatory electrocardiogram processing
technologies," PROCEEDINGS OF THE
10TH ANNUAL CONFERENCE ON COMPUTERIZED INTERPRETATION OF THE
ELECTROCARDIOGRAM, Arzbaecher, R., Bump, T., Jenkins, J., Noh, K.H.
and Ripley K. "Rate, spectra, amplitude histograms and zero-crossings as
identifiers of fibrillation in the intracardiac electrogram,"
Computerized Interpretation of the Electrocardiogram-XIII (Intemational
Society of Computerized Electrocardiography), Arzbaecher, R.
Ripley, K., Bump, T. and Yurkonis, C. "Use of Holter technology to search
an electrophysiologic data base," Third Intemational Symposium on
Holter Monitoring (International Society for Holter Monitoring), Ripley, K.L., "PC Compatibility: An Instrument
Designer's Nightmare," PROCEEDINGS OF THE 25TH ANNUAL AAMI MEETING, Arzbaecher, R., Ripley, K.L., Guenneguez, J., Jadvar, H., Polikaitis, A., and Bump, T. "A combined monitor and pump controller for management of atrial arrhythmias in post surgical patients," PROCEEDINGS OF THE 26TH ANNUAL AAMI MEETING, Washington, D.C., Association for the Advancement of Medical Instrumentation, 1991. Timmermans, C., Rodriguez, L.-M., Smeets, J.L.R.M., Ripley, K., Ayers, G.M. and Wellens, H.J.J, “Effect of intranasal butorphanol on discomfort during internal atrial defibrillation,” Journal Am Coll Cardiol, 1997; 29: p. 474A. Ripley, K.L., Bocek, J., Kim, J., White, H., Tse, H.-F., Siu, C.-W., Ripley, K.L. and Lau, C.-P., “Determinants of lesion dimension during catheter cryoablation: Effects of tip electrode temperature and size,” HEART RHYTHM, 2004; 1(1S): p. S110. Ripley, K.L., Van Vleet, J.F. and Ripley, K.L., Olsen, D.B., Van Vleet, J.F. and Pelkey, W.L., “Effect of Cryothermy Application Duration on Lesion Size in Bovine Epicardium,” HEART RHYTHM, 2005; 2(5S): S239. Ripley, K.L., Feld, G.K., Van Vleet, J.F. and Ayers, G.M., “Transvenous Catheter Ablation of the Right Atrial Free Wall Produces Lung Lesions in Animals,” HEART RHYTHM, 2005; 2(5S): S279. Ripley, K.L., Olson, D., Van Vleet, J.F. and
Pelkey, W.L., “Single-Cycle
Cryoablation Applications Are as Effective as Multi-phase Applications for
Cardiac Lesion Production in Animals,” EUROPEAN HEART JOURNAL, 2005;
26(S1): P523. Tse, H.-F., Ripley, K.L., Zhang, O., Siu, C.-W., Van Vleet, J.F. and Lau, C.-P., “Cryothermal Cooled Radiofrequency Ablation Increases Lesion Size without Risk of Thrombus Formation,” EUROPEAN HEART JOURNAL, 2005; 26(S1): P525. Ripley, K.L., Olsen, D. and Van Vleet, J.F., “Comparison of RF and Cryoablation to Produce Esophageal Injury when Applied Directly to the Exterior of the Bovine Esophagus,” CIRCULATION, 2005; 112(17-II): p. II-492. Ripley, K.L., Olsen, D., Van Vleet, J.F. and Koerner, R., “Exploring the Effects of Cryothermy on Cardiac Tissue,” CRYOBIOLOGY, 2005; 51(3): p. 365. Ripley, K.L., Olson, D., Van Vleet, J.F. and Ayers, G.M., “Direct Injury to the Esophagus from RF and Cryoablation and Their Potential Roles in Understanding the Production of Atrio-Esophageal Fistulas,” HEART RHYTHM, 2006; 4(9): p.112B. Ripley, K.L., Tse,
H.-F., Van Vleet, J.F., Gage, A.A., and Pelkey, W.L., “The Effects of
Docetaxil and Sirolimus on Cryoablation Lesions in Ripley, K.L., Tse,
H.-F., Van Vleet, J.F., and Pelkey W.L., “Cryoablation of skeletal
muscle: the effect of contact force and application duration on lesion
size,” EUROPEAN HEART JOURNAL, 2006; 27(S1): P2084 Ripley, K.L., Olsen, D., Van Vleet, “Esophageal injury as a consequence of ablation with RF and Cryothermy,” EUROPEAN HEART JOURNAL, 2006; 27(S1): P4434 Patents: Ripley, K.L. and Kaplan, D.T. Method and apparatus for ECG Signal Analysis and Cardiac Arrhythmia Detection, US Patent 5,271,411, 1993.
Ripley, K.L., Ayers, G.M. and Lentz, D.J. Warming Gradient Control for a Cryoablation Applicator, WO/2006/083674.
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