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Linoxsmart S DX Master Study
Final Results
Cardiac Rhythm Management
Tachyarrhythmia Therapy
November 2011
2
Proof of safety and efficacy of the Linoxsmart S DX ICD lead
Regulatory support for the approval processes in USA, Japan, Australia and other countries (Master Study)
Linoxsmart S DX Master Study
Study Objectives
119 patients
Study start: March 15, 2010
Prospective, non-randomized, international
Included system components:
Linoxsmart S DX
Lumax 540 VR-T DX
Cardiomessenger II/II-S
Study Design
3
Linoxsmart S DX Master Study
Inclusion
Meet the indications for an ICD therapy
The patient will be available for the follow-up visits
Exclusion
The patient does not meet ICD therapy indications
The patient has permanent atrial tachyarrhythmia
The patient has a life expectancy of less than six month
The patient is younger than 18 years
The patient is expected to have cardiac surgery in the next six months
The patient is enrolled in another cardiac clinical study
Inclusion and Exclusion Criteria
4
Linoxsmart S DX Master Study
Primary endpoint
Rate of appropriate atrial sensing1 > 90%
Secondary endpoint
Linoxsmart S DX complication2-free rate >90%
Endpoints
1.Appropriate atrial sensing: Assessment of 10 consecutive intrinsic atrial beats documented with markers at PHD and 1,3, and 6 month follow-up in dorsal lying position
2.Complication: Linox DX related adverse event with an additional invasive intervention
5
Linoxsmart S DX Master Study
Study Flow Chart
EnrollmentPatient Informed Consent
Implantation
Pre-Hospital-Discharge Follow-up12h - 10 days p.o.
1 Month Follow-up (±1 week)
3 Month Follow-up (±2 weeks)
6 Month Follow-up (±4 weeks)
Study End
6
Linoxsmart S DX Master Study Results
Study Centers and Patient Demographics
Study centers
25 clinics in 7 countries
45 implanters
Patients
116 patients (84% male)
Age: 60±14 years
Primary prevention indication: 73.3%
20 patients with history of AF
LVEF: 36±15 %
NYHA classification at enrollmentI 18%II 56%III 23%IV 3%
7
Linox smart S DX Master StudyAppropriate Atrial Sensing Rate
50
55
60
65
70
75
80
85
90
95
100
PHD 1-month FU 3-month FU 6-month FU
Ap
pro
pri
ate
Atr
ial S
en
sin
g [%
]
Dorsal lying position Sitting, palms together Sitting, Jendrassik's m.
Linoxsmart S DX Master Study Results
Primary Endpoint - Efficacy
Rate of appropriate atrial sensing: 93.8% [p=0.005]
Required rate of
appropriate atrial
sensing to confirm
alternative hypothesis
HA
8
Linoxsmart S DX Master Study Results
Secondary Endpoint - Safety
6 lead-related complications
4 lead repositionings
2 lead exchanges
Linoxsmart S DX complication-free rate: 94.8% [p=0.048]
9
Linoxsmart S DX Master Study Results
Lead Implantation Assessment
Excellent handling characteristics of the new Linoxsmart S DX lead: Over 87% of implantation procedures have been assessed as either very easy or easy
10
Linoxsmart S DX Master Study Results
Lead Implantation Technique
11
Linoxsmart S DX Master Study Results
Lead Insertion Site
12
Linoxsmart S DX Master Study Results
Lead Tip Position
13
Atrial Sensing Amplitude
Linoxsmart S DX Master Study Results
Linox smart S DX Master StudyMean P-wave Amplitude with Standard Deviation
0
1
2
3
4
5
6
7
8
9
10
Implant PHD 1-month FU 3-month FU 6-month FU
P-w
av
e A
mp
lidu
te [
mV
]
14
Linoxsmart S DX Master Study Results
Ventricular Sensing Amplitude
Linox smart S DX Master StudyMean R-wave Amplitude with Standard Deviation
0
2
4
6
8
10
12
14
16
18
20
Implant PHD 1 month FU 3 month FU 6 month FU
R-w
av
e A
mplid
ute
[m
V]
15
Linoxsmart S DX Master Study Results
Ventricular Pacing Threshold
Linox smart S DX Master StudyMean Ventricular Pacing Threshold with Standard Deviation
0.0
0.5
1.0
1.5
2.0
I mplant PHD 1 month FU 3 month FU 6 month FU
Ve
ntr
icu
lar
pa
cin
g t
hre
sho
ld [
V]
16
Linoxsmart S DX Master Study Results
Ventricular Pacing Impedance
Linox smart S DX Master StudyMean Ventricular Pacing Impedance with Standard Deviation
0
200
400
600
800
1000
Implant PHD 1 month FU 3 month FU 6 month FU
Ve
ntr
icu
lar
pa
cin
g i
mp
ed
an
ce [
V]
17
Linoxsmart S DX Master Study Results
Patients with Atrial Tachycardia
Number of Patients
AF history at enrollment 20 (17.2%)
AF appropriately detected during follow-up period in patients with no AF history at enrollment
11 (9.5%)
Other atrial tachycardia detected during follow-up period in patients with no AF history at enrollment
2 (1.7%)
Total 33 (28.4%)
Advanced AF diagnosis with Lumax DX - out of 96 patients with no history of AF at enrollment 11 patients had been diagnosed to have one ore more AF episodes already within 6-month follow-up period of the study.
18
Linoxsmart S DX Master Study Results
Summary
Within the Linoxsmart S DX Master Study the investigated DX system demonstrated
an appropriate atrial sensing rate of 93.8%
a complication-free rate of 94.8%
a handling assessment of either very easy or easy in >87% of the implantation procedures
stable p-wave amplitudes with a mean value of about 5mV at different body position at every visit
appropriate AF detection for the first time in 11 patients with no history of AF at enrollment