Regent China Post-Market Clinical Follow-up Study
Conditions: Valvular Heart Disease, Aortic Valve Disease
Sponsor: Abbott Medical Devices

Clinical Investigation Plan Cover Page 
 
 
 
 
 
 
 
 
 
 
 
NCT Number: NCT05330468 
RC-PMCF 
Regent China Post-Market Clinical Follow-up Study 
Study Document Name: RC-PMCF Clinical Investigation Plan 
Date: 24-May-2022 
 
 
Sponsor  
            Abbott 
 
            5050 Nathan Lane North 
 
            Plymouth, MN 55442 
 
            USA 
 
 
            Abbott Medical (Shanghai) Co., Ltd 
 
            Room 402, 4th Floor, Building B, No. 169 Taigu road, pilot Free Trade Zone, 
 
            Shanghai, China 
 
 
 

 
Study Name: RC-PMCF 
Clinical Investigation Plan 
 
 
 
 
 
 
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APPENDIX IV: LITERATURE REVIEW 
1.        Fiedler AG, Tolis G, Jr. Surgical Treatment of Valvular Heart Disease: Overview of Mechanical 
and Tissue Prostheses, Advantages, Disadvantages, and Implications for Clinical Use. Curr Treat 
Options Cardiovasc Med. Feb 5 2018;20(1):7. 
2. 
Kheradvar A, Groves EM, Goergen CJ, et al. Emerging trends in heart valve engineering: Part II. 
Novel and standard technologies for aortic valve replacement. Annals of biomedical engineering. 
2015;43(4):844-857. 
3. 
Emery RW, Krogh CC, Arom KV, et al. The St. Jude Medical cardiac valve prosthesis: a 25-year 
experience with single valve replacement. Ann Thorac Surg. Mar 2005;79(3):776-782; discussion 
782-773. 
4. 
Ikonomidis JS, Kratz JM, Crumbley AJ, 3rd, et al. Twenty-year experience with the St Jude 
Medical mechanical valve prosthesis. J Thorac Cardiovasc Surg. Dec 2003;126(6):2022-2031. 
5. 
Minakata K, Tanaka S, Okawa Y, et al. Twenty-year outcome of aortic valve replacement with St. 
Jude Medical mechanical valves in Japanese patients. Circ J. 2015;79(11):2380-2388. 
6. 
Saito S, Tsukui H, Iwasa S, et al. Bileaflet mechanical valve replacement: an assessment of 
outcomes with 30 years of follow-up. Interactive cardiovascular and thoracic surgery. Oct 
2016;23(4):599-607. 
7. 
Toole JM, Stroud MR, Kratz JM, et al. Twenty-five year experience with the St. Jude medical 
mechanical valve prosthesis. Ann Thorac Surg. May 2010;89(5):1402-1409. 
8. 
Cigarroa R, Elmariah S. Anticoagulation Management After Transcatheter and Surgical Valve 
Replacement. Curr Treat Options Cardiovasc Med. Apr 11 2018;20(5):42. 
9. 
Falk V, Baumgartner H, Bax JJ, et al. 2017 ESC/EACTS Guidelines for the management of 
valvular heart disease. European journal of cardio-thoracic surgery : official journal of the 
European Association for Cardio-thoracic Surgery. Oct 1 2017;52(4):616-664. 
10. 
Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 2014 
AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of 
the American College of Cardiology/American Heart Association Task Force on Clinical Practice 
Guidelines. J Am Coll Cardiol. Jul 11 2017;70(2):252-289. 
11. 
Feltes TF, Bacha E, Beekman RH, 3rd, et al. Indications for cardiac catheterization and 
intervention in pediatric cardiac disease: a scientific statement from the American Heart 
Association. Circulation. Jun 7 2011;123(22):2607-2652. 
12. 
Badhwar V, Ofenloch JC, Rovin JD, van Gelder HM, Jacobs JP. Noninferiority of closely 
monitored mechanical valves to bioprostheses overshadowed by early mortality benefit in 
younger patients. The Annals of Thoracic Surgery. 2012;93(3):748-753. 
13. 
Bernet FH, Baykut D, Grize L, Zerkowski H-R. Single-center outcome analysis of 1,161 patients 
with St. Jude medical and ATS open pivot mechanical heart valves. The Journal of heart valve 
disease. 2007;16(2):151-158. 
14. 
Bourguignon T, Bergöend E, Mirza A, et al. Risk factors for valve-related complications after 
mechanical heart valve replacement in 505 patients with long-term follow up. Journal of Heart 
Valve Disease. 2011;20(6):673. 
15. 
Chan V, Jamieson WE, Lam B-K, et al. Influence of the On-X mechanical prosthesis on 
intermediate-term major thromboembolism and hemorrhage: a prospective multicenter study. The 
Journal of thoracic and cardiovascular surgery. 2010;140(5):1053-1058. e1052. 

 
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Clinical Investigation Plan 
 
 
 
 
 
 
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16. 
Johnson S, Stroud MR, Kratz JM, Bradley SM, Crawford FA, Jr., Ikonomidis JS. Thirty-year 
experience with a bileaflet mechanical valve prosthesis. Journal of Thoracic and Cardiovascular 
Surgery. 2019-10-14 2019;157(1):213-222. 
17. 
Minakata K, Tanaka S, Tamura N, et al. Comparison of the long-term outcomes of mechanical 
and bioprosthetic aortic valves: A propensity score analysis. Circulation Journal. 2017 
2017;81(8):1198-1206. 
18. 
Nishida T, Sonoda H, Oishi Y, et al. Long-term comparison of three types of aortic St. Jude 
Medical mechanical prosthesis in Japanese patients. Circulation Journal. 2015:CJ-15-0268. 
19. 
Puskas J, Gerdisch M, Nichols D, et al. Reduced anticoagulation after mechanical aortic valve 
replacement: interim results from the prospective randomized on-X valve anticoagulation clinical 
trial randomized Food and Drug Administration investigational device exemption trial. The Journal 
of thoracic and cardiovascular surgery. 2014;147(4):1202-1211. e1202. 
20. 
Van Nooten GJ, Bové T, Van Belleghem Y, et al. Twenty-year single-center experience with the 
medtronic open pivot mechanical heart valve. The Annals of thoracic surgery. 2014;97(4):1306-
1313. 
21. 
Kim SH, Kim HJ, Kim JB, et al. Supra-annular versus intra-annular prostheses in aortic valve 
replacement: impact on haemodynamics and clinical outcomes. Interactive cardiovascular and 
thoracic surgery. 2019;28(1):58-64. 
22. 
Mostafa EA, El Midany AA, Taha AS, et al. On-X versus St Jude medical mechanical prosthesis 
in mitral position: Are we moving forward in design technology? Journal of Cardiovascular 
Surgery. 2018;59(2):252-258. 
23. 
Prifti E, Bonacchi M, Minardi G, et al. Early and Mid-term Outcome of the St. Jude Medical 
Regent 19-mm Aortic Valve Mechanical Prosthesis. Functional and Haemodynamic Evaluation. 
Heart, Lung and Circulation. 2018;27(2):235-247. 
24. 
Zhang H, Dong Y, Ao X, Zhu D, Dong L. Optimal oral anticoagulant therapy in Chinese patients 
with mechanical heart valves. European Journal of Pharmaceutical Sciences. 2020;144:105202. 
25. 
Akins CW, Miller DC, Turina MI, et al. Guidelines for reporting mortality and morbidity after 
cardiac valve interventions. European journal of cardio-thoracic surgery. 2008;33(4):523-528. 
26. 
Criteria Committe NYHAI. Diseases of the Heart and Blood Vessels. Nomenclature and Criteria 
for Diagnosis. 6th ed. Boston: Little, Brown and Co.; 1964. 
27. 
Criteria Committe NYHAI. Nomenclature and Criteria for Diagnosis of Diseases of the Heart and 
Great Vessels. Boston, MA: Lippincott, Williams and Wilkins; 1994. 
28. 
Peto R, Pike M, Armitage P, et al. Design and analysis of randomized clinical trials requiring 
prolonged observation of each patient. I. Introduction and design. British journal of cancer. 
1976;34(6):585-612. 
 
 

 
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APPENDIX VI: CASE REPORT FORMS 
Case report forms will be provided under a separate cover. 
 

 
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Clinical Investigation Plan 
 
 
 
 
 
 
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APPENDIX VII: INFORMED CONSENT FORM 
Informed Consent Form (ICF) templates will be provided under a separate cover. 
 
 
 
 

 
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APPENDIX VIII: MONITORING PLAN 
A copy of the Monitoring Plan can be obtained upon request from the Sponsor Clinical Project Manager 
for the clinical investigation. 
 
 

 
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Clinical Investigation Plan 
 
 
 
 
 
 
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Clinical Investigation Plan 
 
 
 
 
 
 
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APPENDIX X: CIP SUMMARY 
Clinical 
Investigation 
Name and 
Number 
RC-PMCF  
 
Title 
Regent China Post-Market Clinical Follow-up Study  
Objective 
Confirm the long-term safety and performance of Abbott Medical’s Regent, 
model AGN-751 and AGFN-756, for replacement of native or prosthetic aortic 
valves. 
Device Under 
Investigation 
Abbott Medical’s Regent Mechanical Heart Valve 
Number of 
Subjects Required 
for Inclusion in 
Clinical 
Investigation 
200 
Clinical 
Investigation 
Design 
Prospective, non-randomized, observational, multi-center study 
Primary 
Endpoints 
The primary safety endpoint is freedom from valve-related mortality at 5 years.  
 
The primary performance endpoint is freedom from valve-related reoperation at 
5 years.  
Subject Follow-up 
Baseline, implant, discharge, 3-months, 6-months, and annually post-implant 
Inclusion Criteria 
1. Patient is eligible to be implanted with Regent to replace a native or 
prosthetic aortic valve per Regent MHV’s IFU 
2. Subject will be >18 years of age at time of being consented 
3. Subject, provides written informed consent prior to any clinical investigation-
specific procedure. 
Exclusion Criteria 
1. Subject is unable to tolerate anticoagulation therapy 
2. Subject has active endocarditis 
3. Subject is currently participating in another clinical investigation which may 
interfere with the effectiveness of anticoagulation therapy 

 
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4. Pregnant or nursing subjects and those who plan pregnancy during the 
clinical investigation follow-up period. Women of child-bearing potential 
must have a documented negative pregnancy test within one week prior to 
enrollment  
5. Subject has anomalous anatomy or medical, surgical, psychological or 
social history or conditions that, in the Investigator’s opinion, could limit the 
subject’s ability to participate in the clinical investigation or to comply with 
follow-up requirements of the clinical investigation results 
6. Subject is unable to read or write or has a mental illness or disability that 
impairs their ability to provide written informed consent 
7. Subject’s life expectancy is less than 1 year in the opinion of the 
Investigator