Edwards PASCAL Transcatheter Valve Repair System Registry: A Multicenter Observational Registry With the Edwards PASCAL Transcatheter Valve Repair System
Conditions: Mitral Valve Insufficiency
Sponsor: Edwards Lifesciences



Edwards PASCAL Registry (#2019-03) 
 
Edwards Lifesciences, LLC 
 
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. DOC-0077299 Rev: A 
– Clinical Investigation Plan Template Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL Transcatheter Valve Repair System are 
trademarks of Edwards Lifesciences Corporation. 
Version B 
Page 19 of 42 
1.7.2 The CLASP Study 
The Edwards PASCAL TrAnScatheter Mitral Valve RePair System (CLASP) Study is a multi-national, 
prospective, single-arm study aimed to assess the clinical safety and outcomes of the PASCAL 
System in treating adult patients with clinically significant, symptomatic, mitral regurgitation 
despite optimal medical therapy (NCT03170349). 
The primary safety endpoint is a composite of major adverse events at 30 days, which include 
cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, 
severe bleeding, and re-intervention for study device-related complications. The primary 
performance endpoints of the study include device success, procedural success, and clinical 
success. Device success is defined as device deployment 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 MR severity ≤2+ at discharge (Echo Core Lab-evaluated) 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 with evidence of MR 
reduction MR ≤ 2+ and without MAEs at 30 days (analyzed per patient). Secondary endpoints of 
the study include clinical, safety, and functional outcomes at 30-day, 6 month, 1 year, and annual 
follow-up time points. All patients are assessed for clinical follow-up at 30 days, 6 months, 1 year, 
and annually for 5 years post-implant procedure. Patient follow-up is ongoing. 
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. 
 
 
 
 
 
 
 
 
 
 
 

Edwards PASCAL Registry (#2019-03) 
 
Edwards Lifesciences, LLC 
 
PROPRIETARY DATA: THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF EDWARDS LIFESCIENCES, LLC. IT MUST NOT 
BE REPRODUCED OR DISCLOSED TO THIRD PARTIES WITHOUT PRIOR WRITTEN PERMISSION OF EDWARDS LIFESCIENCES, LLC. DOC-0077299 Rev: A 
– Clinical Investigation Plan Template Edwards Lifesciences, Edwards, the stylized E logo, and PASCAL Transcatheter Valve Repair System are 
trademarks of Edwards Lifesciences Corporation. 
Version B 
Page 22 of 42 
3.5 
Inclusion Criteria 
Patients must meet all of the following criteria to be eligible for the Registry: 
1. Patients electively treated or electively intended to be treated with Edwards PASCAL 
Transcatheter Valve Repair System. 
2. Patient provided written informed consent to participate in the registry. 
3.6 
Exclusion Criteria 
Patients will be excluded from the Registry if they meet the following: 
1. Patient is already part of an Edwards Pre or Post Market Clinical study for the PASCAL 
Transcatheter Valve Repair System. 
3.7 
Registry Exit Criteria and Procedures 
The reason for exit from the registry will be documented on the appropriate case report forms 
and in the medical records for each patient who exits the registry. 
Patients may exit the registry for any of the following reasons: 
• Completion per Protocol 
• Withdrawal 
o Patient Withdrawal:  The patient may voluntarily withdraw from the registry at 
any time, without penalty or loss of benefits to which they are otherwise 
entitled. 
o Physician Withdrawal:  The Investigator also has the right to withdraw a patient 
if s/he feels it is in the best interest of the patient to do so. 
o Sponsore Withdrawal:  The Sponsor may prematurely terminate the Registry. 
• Death 
• Device Reintervention or Explant 
o Patients who have a surgical reintervention where the device is explanted will 
be followed for 30 days post-reintervention or until resolution of any adverse 
events related to the procedure and then exited from the registry.  Patients that 
have a percutaneous or surgical reintervention where the device remains in 
place will continue to be followed for the duration of the registry.