Edwards PASCAL Gebrauchsanweisung Seite 8

An independent core lab assessed all echocardiographic data . An independent
clinical events committee (CEC) adjudicated safety events and a data safety
monitoring board (DSMB) independently reviewed aggregate safety data and
evaluated trends of adverse events and their effect on trial conduct and device
risk assessment .
10.1.1 CLASP Study Results
The mean age of the patients treated was 75 . 4 years and 55 . 0 % were male .
All patients had NYHA Class II, III or IV heart failure . The mean Logistic
EuroSCORE I, EuroSCORE II and STS Mortality Score were 14 . 4 %, 5 . 8 % and
4 . 7 %, respectively . At baseline, 50 . 9 % had moderate-severe MR, and 48 . 1 %
had severe MR .
10.1.2 Performance
The performance endpoint included three components of success: device,
procedural, and clinical . Device success was achieved in 92 . 0 % of devices
attempted . Procedural success was achieved in 93 . 5 % of patients . Clinical
success was achieved in 86 . 0 % of patients .
10.1.3 Safety
At 30 days, the composite MAE rate was 8 . 0 % . Nine patients experienced 11
MAEs prior to 30-day follow-up . The CEC Adjudicated MAE at 30 Days by
Counts are shown below .
Major Adverse Event (MAE)
Cardiovascular Mortality
Stroke
Myocardial Infarction
New Need for Renal Replacement Therapy
Severe Bleeding
Re-Intervention for Study Device Related
Complications
Composite MAE Rate
Note: Categorical measures - % (n/Total no)
In the overall population, MR grade reduction (i . e . MR ≤ 2+) was observed in
95 . 3 % of patients at discharge, 96 . 1 % at 30 days, 98 . 8 % at 6 months, and
100% at 1 year .
10.1.4 Study Conclusion
The data collected in the CLASP study supports the safety and performance of
the PASCAL system in patients with mitral regurgitation . The number of
patients with follow-up of one year or more is limited and long-term follow-
up data is collected by means of a Post Marketing Clinical Follow-up study .
10.2 CLASP TR Study
Clinical data in this section includes information obtained from the tricuspid
clinical study (CLASP TR) of the PASCAL transcatheter valve repair system .
A prospective, single arm, multi-center study (CLASP TR) was conducted to
assess the safety, performance, and clinical outcomes of the PASCAL system .
All enrolled study patients were assessed for clinical follow-up at 30 days,
6 months, 1 year, and will continue annually for 5 years post-implant
procedure .
The primary safety endpoint of the CLASP TR study was a composite of major
adverse events (MAEs) at 30 days . The MAEs include: cardiovascular mortality,
myocardial infarction, stroke, renal complications requiring unplanned dialysis
or renal replacement therapy, severe bleeding, unplanned or emergency
Summary Statistics
0 . 9 % (1/112)
0 . 9 % (1/112)
0 . 0 % (0/112)
0 . 0 % (0/112)
7 . 1 % (8/112)
0 . 9 % (1/112)
8.0% (9/112)
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re-intervention (either percutaneous or surgical) related to the device, and
major access site and vascular complications requiring intervention .
The primary performance endpoints of the study include device success,
procedural success, and clinical success . The secondary endpoints of the study
include clinical, safety, and functional outcomes at 30-day, 6-month, 1-year,
and annual follow-up time points .
Device success is defined as device deployed as intended and successful
delivery system retrieval as intended at the time of the patient's exit from the
cardiac catheterization laboratory . Analysis of device success was performed
per device .
Procedural success is defined as device success with evidence of a reduction in
TR grade by at least one grade (scale: non/trace, mild, moderate, severe,
massive, torrential) at the end of the procedure, and without the need for a
surgical or percutaneous intervention prior to hospital discharge . Procedural
success was analyzed per patient .
Clinical success is defined as procedural success without MAEs at 30 days
(analyzed per patient) .
An independent core lab assessed all echocardiographic data . An independent
clinical events committee (CEC) adjudicated safety events and a data safety
monitoring board (DSMB) independently reviewed aggregate safety data and
evaluated trends of adverse events and their effect on trial conduct and device
risk assessment .
10.2.1 CLASP TR Study Results
The mean age of the patients treated was 76 . 3 years and 53% were female .
All patients had NYHA Class II or III heart failure . The mean EuroSCORE II and
STS Mortality Score were 5 . 3 % and 7 . 3 %, respectively . At baseline, 81% of
patients presented with severe or greater TR .
10.2.2 Performance
The performance endpoint included three components of success: device,
procedural, and clinical . Device success was achieved in 82 . 2 % of devices
attempted . Of the implanted patients, procedural success was achieved in
95 . 5 % of patients and clinical success was achieved in 86 . 4 % of patients .
10.2.3 Safety
At 30 days, the composite MAE rate was 5 . 9 % . Two patients experienced 3
MAEs prior to 30-day follow-up . The CEC-adjudicated MAEs at 30 Days by
Counts are shown below .