Symphony
Feasibility, non-randomized study to evaluate the safety, accuracy and performance of the Symphony Transdermal Continuous Glucose Monitoring System in hospitalized patients.
Principal investigator: Anthony Furnary, M.D.
Sponsor: Echo Therapeutics
Contact: Carmen Dahlberg, CRC, clinical research coordinator, 503-216-7370
M13-796 Acute Kidney Injury (AKI)
Randomized, placebo-controlled trial to compare the safety and efficacy of total doses of 800 mcg/kg and two dosing regimens of 1200 mcg/kg intravenous (IV) infusions of ABT-719 to placebo in subjects who are at risk of acute kidney injury and undergoing predefined cardiopulmonary bypass cardiac surgery.
Principal investigator: Jeffrey Swanson, M.D.
Sponsor: AbbVie
Coordinator: Ellen Muir, CCRC, clinical research coordinator, 503-216-2110
The COAPT Trial
Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for high surgical risk patients. A clinical evaluation of the safety and effectiveness of the MitraClip System for the treatment of functional mitral regurgitation in symptomatic subjects at too high risk to undergo mitral valve surgery (IRB 12-101B)
Principal investigator: Ethan Korngold, M.D.
Co-investigators: Jacob Abraham, M.D., Robert Hodson, M.D., Gary Ott, M.D., Alicia Ross, M.D., Jeffrey Swanson, M.D., Craig Walsh, M.D.
Sponsor: Evalve Inc., a subsidiary of Abbott Vascular Inc.
Contact: Carmen Dahlberg, CRC, clinical research coordinator, 503-216-7370, or Michelle Dixon, CCRC, clinical research coordinator, 503-215-6746
The PARTNER II Trial
Placement of AoRtic TraNscathetER Valves Trial. The safety and effectiveness of the SAPIEN Transcatheter Heart Valve with NovaFlex and Ascendra 2 delivery systems (transfemoral, transapical and transaortic) in intermediate risk for aortic valve surgery and patients who cannot undergo surgery.
Principal investigators: Robert Hodson, M.D., and Jeffrey Swanson, M.D.
Co-investigators: Ethan Korngold, M.D., and Eric Kirker, M.D.
Sponsor: Edwards Lifesciences, LLC
Contact: Angela Redd, CCRC, clinical research coordinator, 503-216-2170, or Heather Aiona, CCRC, 503-216-2099
BIOCOR Registry
Post-Approval Study Protocol of the St. Jude Medical Biocor™ and Biocor™ Supra Valve.
The purpose of this study is to gather additional information about the performance of the Biocor and Biocor Supra Valve. About 360 people will take part in this study at up to 25 sites in the United States.
Principal investigator: Jeffrey Swanson, M.D.
Sponsor: St. Jude Medical Cardiovascular Division
Contact: Angela Redd, CCRC, clinical research coordinator, 503-216-2170
PERIMOUNT Magna Ease
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position Model 3300TFX.
The primary objective of the investigation is to obtain long-term human clinical data to demonstrate that the Carpentier-Edwards PERIMOUNT Magna Ease is a safe and effective replacement aortic bioprosthesis.
Principal investigator: Jeffrey Swanson, M.D.
Sponsor: Edwards Lifesciences LLC
Contact: Angela Redd, CCRC, clinical research coordinator, 503-216-2170
NUMERIS™ AF Tethered Coagulation System with VisiTrax®
Indicated for the Treatment of Longstanding Persistent Atrial Fibrillation
Inclusion criteria
- Patient is between ages of 18 to 80 years old
- Documented longstanding persistent Afib or non self-terminating Afib
- Patient scheduled for concomitant cardiac procedure
- Exclusion criteria
- EF <30%
- History of Afib >10 years
- Left atrial size >6.0
Principal investigator: E. Charles Douville, M.D.
Sponsor: nContact Surgical Inc.
Contact: Michelle Dixon, CCRC, clinical research coordinator, 503-215-6746
PROACT Study
Clinical Trial of the On-X Valve Using Low Dose Anticoagulation
Inclusion criteria
- Patient is scheduled to receive ON-X mechanical valve (aortic or mitral)
- Concomitant cardiac surgery is allowed
- Exclusion criteria
- Double (aortic and mitral) valve replacement
- Patients with active endocarditis
- Previous thromboembolic event within last year
Principal investigator: E. Charles Douville, M.D.
Sponsor: On-X/MCRI
Contact: Michelle Dixon, CCRC, clinical research coordinator, 503-215-6746
Artificial Valve Endocarditis Reduction Trial (AVERT) (in follow-up)
A Prospective Randomized Trial to Determine the Effects of Silzone Coating on the Incidence of Prosthetic Valve Endocarditis (also conducted at PPMC)
Principal investigators: Jeffrey Swanson, M.D., E. Charles Douville, M.D.
Sponsor: St. Jude Medical S.C. Inc.
Mitroflow Synergy PC Valve Study (in follow-up)
G020247/S001 CarboMedics/Sorin
Principal investigator: Jeffrey Swanson, M.D.