TAVR with J•Valve™ Ausper System for Treatment of Pure Aortic Regurgitation

and Aortic Stenosis First-in-human China clinical trial

Jian (James) Ye, MD, FRCSC (On behalf of Trial Investigators)

Clinical Professor

Division of Cardiovascular Surgery

St. Paul’s Hospital and Vancouver General Hospital

University of British Columbia, Vancouver, Canada

Potential conflicts of interest

Speaker's name: Jian (James) Ye

I have the following potential conflicts of interest to report: Consultant: Edwards Lifesciences JC Medical Inc.

J·ValveTM Bioprosthesis

-Woven polyester fabric

-Porcine aortic valve

-Nitinol clasper to locate and anchor the valve

-Stent frame -suture

J·ValveTM Ausper system

Ausper Delivery Device

Control Knob 1

Control Knob 2

Control Knob 3

Release Control Knob

Main Handle – Stationary Handle Grip

Nose Cone

Sheath

Confidential Property of JC Medical, Inc.

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②

③

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⑤

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⑦ ① ④ ⑤ ② ③

AI Case Treated with JValve

Principal Investigators

Guo, YingQiang, MD West China Hospital, Chengdu, China Shi, YingKang, MD Wei, Lai, MD ZhongShan Hospital, Shanghai, China Wang, ChungSheng, MD Wang, Wei, MD Fuwai Hospital, Beijing, China Wang, Xin, MD

Trial Design

• Study Design:

Prospective, multi-center, non-randomized, single-arm observational study

• Primary Endpoint:

All cause mortality at 30-days and 12 months

• Secondary Endpoint:

- cardiac function, NYHA at 30 days, 6 and 12 month follow-up

• Main Inclusion Criteria:

- symptomatic severe AS or moderate-severe AI

- high risk determined by heart team or EuroSCORE ≥20%

Other Important Endpoints

• Safety

Cardiac mortality

MI

Stroke

Acute kidney injury

Major vascular complication

Life threatening bleeding

Repeat AV intervention or reopration

Endocarditis

Permanent pacemaker

• Echo Valve Performance

Mean transaortic pressure gradient

Effective orifice area

LVEF

Paravalvular regurgitation

Patient Characteristics

Characteristic

Age (years) 74.4±5.2

Male (%) 54.2%

EuroSCORE (%) 27.5±8.3

NYHA Class III or IV (%) 97.2

Cerebravascular disease (%) 6.5

PVD (%) 52.3

CAD (%) 18.7

Prior CABG (%) 1.9

Atrial fibrillation (%) 19.6

DM (%) 15.0

Mortality

All Cause Mortality All patients

N=107 (64 AS and 43 AI)

Intraoperative death (%) 0

30-day mortality (%) 4.67

6-month mortality (%) 5.65

12-month Mortality (%) 5.65

Complications

Complications 30 days 12 months

CVA (%) 0 3.1

MI (%) 0 0

Acute kidney injury (%) 1.0 n/a

Pacemaker(%) 2.8 4.3

Reoperation(%) 0.9 2.4

0%

20%

40%

60%

80%

100%

Before-Op 30 Day 6 M 12 M

Pre- and Post-Op NYHA Class

I II III IV

Mean Transaortic Pressure Gradient

0

20

40

60

80

Before-Op During-Op Post-Op 7 Day 30 Day 6 M 12 M

mmHg

AS

AI

Paravalvular Leak

7 Days 30 Days 6 M 12 M

2,00% 0,00% 0,00% 0,00%

29,00% 33,68% 30,77% 27,87%

32,00% 31,58% 29,67%

26,23%

37,00% 34,74% 39,56% 45,90%

Moderate Mild Trivial None

Survival

0,0

0,2

0,4

0,6

0,8

1,0

0 60 120 180 240 300 360

Days following TAVR

Surv

ival

rat

e

94.4%

Conclusions

• All-cause 30-day mortality: 4.67%

• One-year survival: 94.4%

• NYHA class I-II in 98% of patients at 30-day post-TAVR

(NYHA class III or VI in 97.2% patients at baseline)

• Technical success rate: 93.3%

Device success rate: 89.5% at 30-day post-TAVR

Paravalvular leak less than mild in 98% of patients

• J·ValveTM system: reliable, safe and efficacious for the

treatment of both aortic stenosis and pure aortic

regurgitation

Thanks