Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal study to assess the safety and efficacy of transcatheter mitral valve repair with the Edwards PASCAL transcatheter valve repair system compared to Abbott MitraClip® in patients with mitral insufficiency.
Summary description of the study
This study includes 2 different groups: the randomized group and the registry group. A registry patient is not randomized. The investigator informs the patient which group they will be assigned to. Participation in the study occurs over approximately 5 years and is voluntary. Up to 1247 patients will participate at over 99 international trial centers, with up to 30 patients in Switzerland. Of the 99 trial centers in total, up to 15 trial centers in Europe may participate. The PASCAL system received European CE marking in February 2019 and is approved in Switzerland. It is routinely used as standard treatment for the same condition as yours. The MitraClip® system was approved in 2008 in Europe and Switzerland for the treatment of patients with moderate to severe degenerative mitral insufficiency (DMI - also known as primary MI), in whom the surgical risk is deemed prohibitive (high), as well as for patients with symptomatic heart failure with moderate to severe functional mitral insufficiency (FMI - also known as secondary MI). The aim of the study is to determine the safety and performance of the Edwards PASCAL transcatheter valve repair system (PASCAL system) compared to the Abbott MitraClip® transcatheter mitral valve repair system (MitraClip® system) in patients with mitral insufficiency.
(BASEC)
Intervention under investigation
Medicine fundamentally distinguishes between degenerative mitral insufficiency (DMI) and functional mitral insufficiency (FMI).
Mitral insufficiency (DMI) is termed degenerative when changes to the heart valve itself have been identified as the cause. In contrast, functional mitral insufficiency (FMI) is the result of changes in the surrounding structures, primarily the left ventricle (heart chamber).
This study includes 2 different groups: a randomized group and a registry group.
Both groups will include patients with functional and degenerative mitral valve insufficiency.
The aim of the randomized study group is to compare the PASCAL system with the MitraClip® system for all patients, regardless of the type of mitral insufficiency.
Randomizing means that it is drawn by lot who receives which treatment. It is therefore random whether you receive the PASCAL system or the MitraClip® system, should you be part of the randomized group. The registry group is a so-called “single-arm” study, which means that you will not be randomized and will receive treatment with the PASCAL system in any case.
The aim of the registry group is to collect data on the performance and safety of the PASCAL system, for all patients with DMI or FMI, who are not eligible for a MitraClip® treatment.
The PASCAL and MitraClip® systems were developed to reduce the intensity of MI, so that no surgery is required and the treatment is less invasive (intervening in the body). The PASCAL and MitraClip® systems can be performed with a minimally invasive technique, through transcatheter treatment.
A transcatheter treatment is a minimally invasive technique. Minimally invasive refers to surgical procedures with the smallest possible incision in the body surface. Unlike other therapies, both systems are introduced in the groin area (femoral vein), i.e., through a puncture (opening) of this vein. This eliminates the need to open the chest to insert the implant. This shortens recovery time and hospital stay.
(BASEC)
Disease under investigation
Mitral insufficiency (MI) is a condition in which the mitral valve of the heart does not close tightly, causing blood to flow backward in the heart. This condition increases the workload on the heart and can, if left untreated, increase the risk of worsening heart failure. This means that the heart's pumping ability is not sufficient to pump enough blood into the body. This heart valve problem requires surgery to repair the defective heart valve.
(BASEC)
-18 years or older -The patient is classified by a cardiology team as a candidate for both the PASCAL system and the MitraClip system for transcatheter mitral valve repair -The patient must be classified by the executor of the intervention at the trial center as a candidate for transseptal catheterization In a transseptal catheterization, after inserting a catheter (hollow tube) into the right side of the heart, a small hole is punctured in the wall between the right and left sides of the heart with a needle. The catheter is then moved through the hole into the left side of the heart. (BASEC)
Exclusion criteria
-Patients for whom a TEE (transesophageal echocardiogram) is contraindicated or cannot be successfully performed during screening -Anatomy of the mitral valve that prevents proper access or use of the PASCAL or MitraClip systems, or adequate reduction of mitral insufficiency -Patients with refractory heart failure requiring early intervention In the case of refractory heart failure, the patient, although receiving medications to treat their heart condition, still has severe symptoms that cannot be controlled by medications. (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Edwards Lifesciences LLC, Julie Petra
(BASEC)
Contact
Contact Person Switzerland
Julie Petra
+41 792457121
TMTT_ClinicalEMEAC@clutteredwards.comEdwards Lifesciences
(BASEC)
General Information
University of Virginia,The Heart Hospital Baylor Plano,Morristown Medical Center,Piedmont Healthcare,The Heart Hospital Baylor Plano,Intermountain Medical Center,LMU M?nchen, Campus Gorsshadern,/ Universit?tsmedizin Mainz- Zentrum f?r Kardiologie,
(949) 250-2500
TMTT_ClinicalEMEAC@clutteredwards.com(ICTRP)
General Information
University of VirginiaThe Heart Hospital Baylor PlanoMorristown Medical CenterPiedmont HealthcareThe Heart Hospital Baylor PlanoIntermountain Medical CenterLMU Mnchen, Campus Gorsshadern/ Universittsmedizin Mainz- Zentrum fr Kardiologie
(949) 250-2500
TMTT_ClinicalEMEAC@clutteredwards.com(ICTRP)
Scientific Information
University of Virginia,The Heart Hospital Baylor Plano,Morristown Medical Center,Piedmont Healthcare,The Heart Hospital Baylor Plano,Intermountain Medical Center,LMU M?nchen, Campus Gorsshadern,/ Universit?tsmedizin Mainz- Zentrum f?r Kardiologie,
(949) 250-2500
TMTT_ClinicalEMEAC@clutteredwards.com(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
16.02.2021
(BASEC)
ICTRP Trial ID
NCT03706833 (ICTRP)
Official title (approved by ethics committee)
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with mitral regurgitation. (BASEC)
Academic title
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation (ICTRP)
Public title
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (ICTRP)
Disease under investigation
Degenerative Mitral Valve DiseaseMitral RegurgitationMitral InsufficiencyFunctional Mitral Regurgitation (ICTRP)
Intervention under investigation
Device: Edwards PASCAL SystemDevice: Abbott Mitraclip System (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Eighteen (18) years of age or older
- Patient is able and willing to give informed consent and follow protocol procedures,
and comply with follow-up visit requirements.
- Patient is determined to be at prohibitive risk for mitral valve surgery by the
heart team (CLASP IID cohort only).
- Patient is on stable heart failure medications/Guideline Directed Medical Therapy
(CLASP IIF cohort only)
- Patient is determined to be a candidate for transcatheter mitral valve repair by the
heart team for both PASCAL and MitraClip
- Mitral regurgitation (3+ to 4+) by echo
- Suitable valve and regurgitant jet morphology
- Elevated corrected BNP > 400 pg/ml or corrected NT-pro BNP of > 900 pg/ml or heart
failure hospitalization within the past 12 months (CLASP IIF cohort only)
- LVEF = 20% (and = 50% CLASP IIF cohort only)
Exclusion Criteria:
- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
- Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use
and/or deployment or sufficient reduction in mitral regurgitation
- Patient with refractory heart failure requiring advanced intervention (i.e. left
ventricular assist device, Status =5 heart transplantation) (ACC/AHA Stage D heart
failure)
- Clinically significant, untreated coronary artery disease
- Recent stroke
- Other severe valve disorders requiring intervention
- Need for emergent or urgent surgery for any reason or any planned cardiac surgery
within the next 12 months
- Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding
chordal replacement or surgical annuloplasty repair)
- Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
- Active rheumatic heart disease or rheumatic etiology for MR
- Severe aortic stenosis or regurgitation
- Known history of untreated, severe carotid stenosis
- Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
- Severe COPD
- Pregnant or planning pregnancy within next 12 months. Note: Female patients of
childbearing potential need to have a negative pregnancy test performed within 14
days prior to intervention and be adherent to an accepted method of contraception
- Concurrent medical condition with a life expectancy of less than 12 months in the
judgment of the Investigator
- Patient is currently participating in another investigational biologic, drug or
device clinical study where the primary study endpoint was not reached at time of
enrollment
- Other medical, social, or psychological conditions that preclude appropriate consent
and follow-up, including patients under guardianship (ICTRP)
not available
Primary and secondary end points
PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs).;PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort.;PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. (ICTRP)
Rates of various adverse events;Functional Improvement (increase in 6 minute walk test in meters);Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years;Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years;Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through (ICTRP)
Registration date
10.10.2018 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Scott Lim, MD;Robert Smith, MD;Linda Gillam, MD;Vinod Thourani, MD;Paul Grayburn, MD;Brian K Whisenant, MD;J?rg Hausleiter, MD;Ralph Stephan von Bardeleben, MD;Edwards TMTT Clinical Affairs, TMTT_Clinical@edwards.com, (949) 250-2500, University of Virginia,The Heart Hospital Baylor Plano,Morristown Medical Center,Piedmont Healthcare,The Heart Hospital Baylor Plano,Intermountain Medical Center,LMU M?nchen, Campus Gorsshadern,/ Universit?tsmedizin Mainz- Zentrum f?r Kardiologie, (ICTRP)
Secondary trial IDs
2018-07 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT03706833 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available