DIAMOND-AF CLINICAL TRIAL

A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients with Paroxysmal Atrial Fibrillation

The DiamondTemp™ Ablation System

1

BACKGROUND Tissue temperature is a well-established biophysical parameter of irreversible tissue damage. Irrigated RF was introduced to mitigate the risk of char and thrombus formation; however, thermal acuity is disrupted.

To address these limitations, the DiamondTemp ablation (DTA) system was designed to accurately measure tip-tissue temperature during energy delivery.

STUDY DESIGN The DAF trial was an FDA-regulated, prospective, multicentre, noninferiority, randomised, controlled trial which compared the safety and effectiveness of the DTA system and a CF-RF ablation system (TactiCath™) (control).

482 paroxysmal AF patients were randomised (239 DTA system and 243 control) for PVI at 23 sites in the United States, Europe, and Canada. Patients were followed for 12 months.

STUDY POPULATION Key Inclusion Criteria: Symptomatic paroxysmal AF

– At least two self-terminating AF episodes reported in last 6 months

– At least one ECG documented episode in last 12 months

Prior Class I-IV AAD failure ≥ 18 years of age

Key Exclusion Criteria: Prior cardiac interventions Neurological events within 6 months Class III/IV or uncontrolled heart failure Left ventricular ejection fraction < 35% Left atrial diameter > 5.5 cm

DIAMOND-AF (DAF) CLINICAL TRIAL

Primary Effectiveness Endpoint: Freedom from recurrence of atrial arrhythmias (AF/AFL/AT)

PRIMARY ENDPOINTS Effectiveness:The primary effectiveness endpoint was freedom from recurrence of an atrial arrhythmia (AF, AFL, AT) during the effectiveness period. This was a composite endpoint of seven failure criteria.

Safety:The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30 days and clinically symptomatic pulmonary vein stenosis through six months post-index ablation procedure.

Index Procedure

Effectiveness Failure Criteria Inability to isolate all PVs Use of a non-study device ≥ 1 repeat procedure

Effectiveness Failure Criteria Documented ≥ 30 sec of AF/AFL/AT New or modification to pre-existing Class I-IV AAD DCCV Repeat procedure

90-day Blanking 12-month Follow-up

EFFECTIVENESS PERIOD

Comparing the DiamondTemp ablation system versus a contact-force sensing ablation system (CF-RF).

0

20

40

60

80

100

3 6 9 12

Free

dom

fro

m P

rim

ary

Effec

tive

ness

Eve

nt F

ailu

re (%

)

Months from Index Ablation Procedure

90-d

ay B

lank

ing

Peri

od

12-month Kaplan-Meier EstimateDTA 79.8% (95% CI: 73.9–84.4%)FS Control 76.2% (95% CI: 70.8–81.2%)Log-rank p = 0.47

No. at RiskDTA 239 234 200 185 117 9FS Control 243 236 210 189 121 13

0

20

40

60

80

100

3 6 9 12

Free

dom

fro

m

Repe

at A

blat

ion

(%)

Months from Index Ablation Procedure

90-d

ay B

lank

ing

Peri

od

12-month Kaplan-Meier EstimateDTA 94.7% (95% CI: 90.8–96.9%)FS Control 94.3% (95% CI: 90.4–96.7%)Log-rank p = 0.91

No. at RiskDTA 239 234 225 216 140 12FS Control 243 236 228 222 149 17

Primary Efficacy Endpoint Efficacy Performance by Catheter

PRIMARY SAFETY ENDPOINT MET

3.3% Safety Event rate compared with 6.6% with contact force-sensing RF.

PRIMARY EFFECTIVENESS ENDPOINT MET

79.1% Compared with 75.7% with contact force-sensing RF.

The DTA system met safety and efficacy endpoints, while also demonstrating procedural efficiencies versus CF-RF.

DTA demonstrated favorable off-drugs effectiveness compared to CF-RF (59.4% and 49.4%, p-value < 0.05).

Results from the DAF trial demonstrated the DTA system is a safe, effective, and efficient treatment for paroxysmal AF.

PRIMARY SAFETY & EFFICACY ENDPOINT ACHIEVED

Metric DTA Group Control Group % Reduction with DTA

Total RF time 17.9 ± 8.1 min 29.8 ± 14 min 39.9%

Individual RF ablation duration

14.7 ± 5.3 s 32.6 ± -25.3 s 54.9%

Saline infusion volume 332.2 ± 120.8 ml 785.5 ± -351.5 ml 57.7%

EFFICIENCY OUTCOMES VERSUS CF-RF

The DTA system demonstrated procedural efficiencies compared to CF-RF.

EFFICIENCY

DATA

40%Reduction in

RF time

55%Reduction in

individual RF ablation

duration

58%

Reduction in saline infusion

Within the DTA group, procedural efficiencies were realised after the first 10 cases.

Procedure time, LA dwell time, total RF time, and RF ablation duration were significantly shorter during procedures 11–30 at a site when compared to procedures 1–10.

ADDITIONAL

PROCEDURAL EFFICIENCIES

100

114.9 ± 48.3

Procedure 1–10

A P = 0.03

Proc

edur

e T

ime

(min

)

102.0 ± 41.9

Procedure 11–30

200

300

400

Procedure Time (min)12.9% reduction

19.0 ± 8.5

Procedure 1–10

C P = 0.01

Tota

l RF

Tim

e (m

in)

16.3 ± 7.2

Procedure 11–30

60

50

40

30

20

10

Total RF Time (min)13.1% reduction

50

87.0 ± 33.5

Procedure 1–10

B P = 0.03LA

Dw

ell T

ime

(min

)

77.4 ± 34.0

Procedure 11–30

100

150

200

LA Dwell Time (min)11.0% reduction

15.3 ± 6.2

Procedure 1–10

D P = 0.008

Abl

atio

n D

urat

ion

(sec

)

13.7 ± 3.2

Procedure 11–30

50

40

30

20

10

Ablation Duration (sec)10.0% reduction

The DAF trial was an FDA-regulated, prospective, multicentre, single-blind, noninferiority, (1:1) randomised, controlled trial designed to compare the safety and effectiveness of the DTA system against a contact force-sensing ablation system (control arm) for the treatment of patients with drug-refractory, recurrent, symptomatic, paroxysmal AF during a 12-month evaluation.

Safety and efficacy of the DTA system proved noninferior to force-sensing RF ablation for the treatment of patients with paroxysmal AF. Procedural efficiencies were observed using the DTA system with shorter total RF times, individual RF ablation durations, and less saline infusion.

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Brief StatementSee the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.

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TRIAL SUMMARY

AND CONCLUSION