NCT03706833: CLASP IID/IIF

Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Active, enrolled NA Last updated 9 April 2026

What this trial tests

NA trial testing Edwards PASCAL System in Degenerative Mitral Valve Disease in 1,247 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 November 2018

Primary endpoint
30 June 2026

30 June 2031

Quick facts

Lead sponsor	Edwards Lifesciences
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,247
Start date	30 November 2018
Primary completion	30 June 2026
Estimated completion	30 June 2031
Sites	86 locations across Switzerland, Canada, United States, Germany

Drugs / interventions tested

• Edwards PASCAL System
• Abbott Mitraclip System

Conditions studied

• Degenerative Mitral Valve Disease — all drugs for Degenerative Mitral Valve Disease →
• Mitral Regurgitation — all drugs for Mitral Regurgitation →
• Mitral Insufficiency — all drugs for Mitral Insufficiency →
• Functional Mitral Regurgitation — all drugs for Functional Mitral Regurgitation →

Sponsor

Edwards Lifesciences — full company profile →

Who can join

18 and older, any sex, with Degenerative Mitral Valve Disease or Mitral Regurgitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.
   Lim DS, Smith RL, Gillam LD, Zahr F, et al · · 2022 · cited 109× · PMID 36121247 · DOI 10.1016/j.jcin.2022.09.005
2. Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review.
   Fudim M, Abraham WT, von Bardeleben RS, Lindenfeld J, et al · · 2021 · cited 66× · PMID 34446165 · DOI 10.1016/j.jacc.2021.06.040
3. Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation.
   Hausleiter J, Lim DS, Gillam LD, Zahr F, et al · · 2023 · cited 47× · PMID 36725171 · DOI 10.1016/j.jacc.2022.11.034
4. Transcatheter mitral valve repair: an overview of current and future devices.
   De Backer O, Wong I, Taramasso M, Maisano F, et al · · 2021 · cited 25× · PMID 33911022 · DOI 10.1136/openhrt-2020-001564
5. State-of-the-art intra-procedural imaging for the mitral and tricuspid PASCAL Repair System.
   Hahn RT, Kodali SK. · · 2022 · cited 23× · PMID 34136901 · DOI 10.1093/ehjci/jeab040
6. PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation.
   Gerçek M, Roder F, Rudolph TK, Fortmeier V, et al · · 2021 · cited 19× · PMID 33837469 · DOI 10.1007/s00392-021-01845-8
7. Mitral Interventions in Heart Failure.
   Lander MM, Brener MI, Goel K, Tang PC, et al · · 2023 · cited 11× · PMID 37611988 · DOI 10.1016/j.jchf.2023.07.016
8. Transcatheter Treatment of Mitral Regurgitation.
   McInerney A, Marroquin-Donday L, Tirado-Conte G, Hennessey B, et al · · 2022 · cited 8× · PMID 35629048 · DOI 10.3390/jcm11102921