CARILLON™ Mitral Annuloplasty Device European Union Study

Cardiac Dimensions® CARILLON™ Mitral Contour System™

Disclosures

Nothing to Disclose

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AMADEUS™ Investigators

Hamburg University Cardiovascular Center

Prof. Dr. med. Joachim Schofer (PI) - Dr. Thilo Tübler - Ms. Anya Hoffman (Study Coordinator)

Universität zu KölnProf. Dr. med. Uta Hoppe - Dr. Mathias Brandt - Ms. Iris Berg (Study Coordinator)

OLVG (Amsterdam)Dr. Jean Paul HerrmanDr. Ton Slagboom (IC) - Dr. Gijsbert de Ruiter (EP) - Dr. Edske ter Bals (Study Coordinator)

Cardiac & Rehabilitation Hospital – Kowanówku

Prof. Dr. med. Tomasz Siminiak - Dr. Olga Jerzykowska (Echo) - Dr. Piotr Kalmucki (Study Coordinator)

Stadtische Kliniken NeussProf. Dr. med. Michael Haude - Dr. Hubertus Degen (Study Coordinator)

- Dr. Mathias Breise (Echo)

AZM (Maastricht)Dr. Luz Maria RodriguezDr. J. Vainer (IC) - Dr. David van Kraaij (HF) - Ms. Suzanne Philippines (Study Coordinator)

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• Coronary Sinus approach

• Results Immediately observable

• Tension / Plication is controlled by operator

• Recapture Feature allows for Management of Coronary Arteries

• Does not preclude other HF therapies such as Bi-V pacing or surgery

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Percutaneous Annuloplasty for Functional MR

CARILLON™ Animation

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The AMADEUS™ Trial Study Design:

• Prospective, single-arm, 30 patient, Six month, multi-center trial

Inclusion Criteria• Dilated Ischemic or Non-ischemic Cardiomyopathy (LVEDd > 55mm)• NYHA Class II – IV• FMR moderate to severe• EF < 40%• 6 MWT distance between 150m & 450m• Stable on heart failure meds

Primary Endpoint: • Thirty day rate of Major Adverse Events

Secondary Endpoints: Long-term safety; Hemodynamic and functional changes• NYHA Class• Exercise (6 minute walk test; Maximum Exercise Time)• QOL (KCCQ)• Change in MR

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Baseline DemographicsIntent to Treat Population (n=48)

AMADEUS™ Trial

Age 64 (25-81 yrs)

Gender M = 83% (40)F = 17% (8)

History of CAD 73%

NYHA Class II - 9 III - 37IV - 2

EF 29% (10-39)

MR

(TEE Procedure Baseline)

2+ = 153+ = 184+ = 15

LVEDD 67 mm (50 – 92 mm)

AMADEUS™ Patients were at High Cardiovascular Risk

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AMADEUS™ Enrollment Tree

Enrolled PatientsN=48

CARILLON™ “XE” Procedure Initated

N=39

ImplantedN=29

Procedure Not Initiated

N=5

“Original” CARILLON™ Procedure

N=4

ImplantedN=1

Not Implanted N=3

• Insufficient MR reduction (4)• Coronary Compromise (1)• Both (5)

• Dissection / Perforation (3)• Screen Failure (2)

• Slip

Not Implanted N=10

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Major Adverse Event RatePrimary Safety Endpoint at 30 Days

Event Intention to Treat (n=48**)

Death 2.2% (1 / 46)

Myocardial Infarction Enzyme bump only. No Sx or EKG change (n=2)

Enzyme bump plus EKG change (n=1)

6.5% (3 / 46)

CS Perforation During venous access. Non device related

6.5% (3 / 46)

Device Embolization 0.0% (0 / 46)

Surgery or PCI related to device failure 0.0% (0 / 46)

**Two patients withdrew consent before 25 days F/U

Total Major Adverse Events13% (6/46)

(7 events in 6 patients)

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Managing Coronary Arteries

• 11 cases of crossed arteries required device “Recapture”• In 5 cases, a 2nd device was successfully placed proximal

Arteries crossed in 84% of cases

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Chronic MR Reduction AMADEUS™ Implanted Patients (n=30 at Baseline)

Quantitative MR Measures @Baseline, One, & Six Months

cm cm2

ml

% A

rea

P<0.001

1127% Reduction in FMR on average @ 6 months

Sustained Benefit through 6 Mo.MR Reduction / LV Wall Motion

Baseline 1 Mo 3 Mo 6 Mo

Core Lab MR 3+ 0 0 0

NYHA II I I

6 MWT (meters) 320 450 400

Max Exercise (sec) 540 900 1080

QOL (KCCQ) 31.00 91.00 98.96

49 yr old Male

Baseline 3 Months

6 Months

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NYHA Classification

P < 0.001

n=30 n=27 n=25

At baseline, 80% of patients were NYHA Class III or IVAt 6 Months, 88% of patients were NYHA Class I or II

Six Minute Walk Test

P < 0.001

Me

ters

n=30 n=26 n=23

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QOLKCCQ Overall Summary

P < 0.001

n=30 n=27 n=25

QOLPatient portion of Global Assessment

Assessment 1 month 6 months

Markedly improved 27% 36%

Moderately improved 31% 24%

Slightly improved 19% 24%

No change 11% 8%

Slightly worse 8% 8%

Moderately worse 0% 0%

Markedly worse 4% 0%

n=26 n=25

} 77% } 84%

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AMADEUS™ Procedural Times

• Procedure Times steadily declined over the course of the study• Reduced Procedure time benefits sick HF Population

Min

utes

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At Baseline After Deployment

CARILLON™: Poznan case

AMADEUS™ Study Conclusions

AMADEUS™ study achieved its safety endpoint with an acceptable MAE profile. 13% MAE rate @ 30 days was primarily non-device related.

At-risk coronary arteries were successfully managed in AMADEUS™ with the CARILLON™ “recapture” feature.

MR was reduced by 27% out to 6 months.

Statistically significant improvements in functional parameters out to 6 months (e.g., exercise, NYHA, QOL) .

Short, simple procedure is important for this unstable HF patient population.

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