NCT03170349 (CLASP) is a NA clinical trial of Mitral Valve Repair in Mitral Valve Regurgitation, sponsored by Edwards Lifesciences.

Who is sponsoring NCT03170349?

NCT03170349 is sponsored by Edwards Lifesciences.

What drugs are being tested in NCT03170349?

Interventions in NCT03170349: Mitral Valve Repair.

What condition does NCT03170349 study?

NCT03170349 studies Mitral Valve Regurgitation.

Is NCT03170349 still recruiting?

NCT03170349 is currently completed. Last updated 5 February 2026.

Are results published for NCT03170349?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2026-02-05 · How we verify

NCT03170349: CLASP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

Completed NA Results posted Last updated 5 February 2026

What this trial tests

NA trial testing Mitral Valve Repair in Mitral Valve Regurgitation in 124 participants. Completed in 27 May 2025.

Timeline

27 June 2017

Primary endpoint
30 July 2020

27 May 2025

Quick facts

Lead sponsor	Edwards Lifesciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	124
Start date	27 June 2017
Primary completion	30 July 2020
Estimated completion	27 May 2025
Sites	17 locations across Italy, Greece, Germany, Canada, Switzerland, Australia, United States

Drugs / interventions tested

Mitral Valve Repair

Conditions studied

Mitral Valve Regurgitation — all drugs for Mitral Valve Regurgitation →

Sponsor

Edwards Lifesciences — full company profile →

Who can join

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

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Major Adverse Events (MAE) Primary · 30 days

Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days post-implant. MAEs during the first year of post-implant follow-up were adjudicated by a Clinical Events Committee of independent heart specialist physicians.

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	10

Device Success Primary · Exit from the cardiac catheterization laboratory

Device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	175

Number of Participants With Procedural Success Primary · through discharge

Device success with evidence of mitral regurgitation reduction to ≤ 2+ (mild-moderate) at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	115

Clinical Success Primary · 30 days

Procedural success with evidence of MR reduction to ≤ 2+ (mild-moderate) and without MAEs at 30 days. Mitral regurgitation was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	105

Mitral Regurgitation Reduction Secondary · Baseline, 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

Mitral regurgitation (MR) severity at 30 days, 6 months, 1 year and annually thereafter. Mitral regurgitation reduction was assessed by independent echocardiographic core laboratory review of transthoracic echocardiography (TTE) imaging.

Baseline

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	0
Edwards PASCAL Transcatheter Mitral Valve Repair System	1
Edwards PASCAL Transcatheter Mitral Valve Repair System	0
Edwards PASCAL Transcatheter Mitral Valve Repair System	66

30 Days

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	18
Edwards PASCAL Transcatheter Mitral Valve Repair System	72
Edwards PASCAL Transcatheter Mitral Valve Repair System	23
Edwards PASCAL Transcatheter Mitral Valve Repair System	2

6 Months

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	17
Edwards PASCAL Transcatheter Mitral Valve Repair System	64
Edwards PASCAL Transcatheter Mitral Valve Repair System	28
Edwards PASCAL Transcatheter Mitral Valve Repair System	2

1 Year

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	13
Edwards PASCAL Transcatheter Mitral Valve Repair System	57
Edwards PASCAL Transcatheter Mitral Valve Repair System	22
Edwards PASCAL Transcatheter Mitral Valve Repair System	0

2 Years

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	11
Edwards PASCAL Transcatheter Mitral Valve Repair System	40
Edwards PASCAL Transcatheter Mitral Valve Repair System	18
Edwards PASCAL Transcatheter Mitral Valve Repair System	2

3 Years

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	10
Edwards PASCAL Transcatheter Mitral Valve Repair System	32
Edwards PASCAL Transcatheter Mitral Valve Repair System	14
Edwards PASCAL Transcatheter Mitral Valve Repair System	3

4 Years

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	9
Edwards PASCAL Transcatheter Mitral Valve Repair System	28
Edwards PASCAL Transcatheter Mitral Valve Repair System	5
Edwards PASCAL Transcatheter Mitral Valve Repair System	2

All-cause Mortality Secondary · 30 days, 6 months, 1 year, 2 years, 3 years, 4 Years

All-cause mortality at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative deaths at each time point.

30 days

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	1

6 months

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	4

1 year

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	10

2 years

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	23

3 years

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	31

4 years

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	45

Recurrent Heart Failure Hospitalization Secondary · 30 days , 6 months, 1 year, 2 year, 3 year, 4 year

Recurrent heart failure hospitalization at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative heart failure hospitalizations at each time point.

30 days

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	3

6 months

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	10

1 year

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	15

2 year (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	23

3 year (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	29

4 years (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	33

Reintervention Rates for Mitral Regurgitation Secondary · 30 days, 6 months, 1 year, 2 year, 3 year, 4 year

Reintervention rates for mitral regurgitation at 30 days, 6 months, 1 year and annually thereafter. The data are presented as cumulative reintervention rates at each time point.

30 days

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	1

6 months

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	2

1 year

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	2

2 year (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	3

3 year (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	4

4 years (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	6

Composite of Major Adverse Events (MAEs) Defined as Cardiovascular Mortality, Stroke, Myocardial Infarction, New Need for Renal Replacement Therapy, Severe Bleeding and Reintervention for Study Device Related Complications. Secondary · 6 months, 1 year, 2 year, 3 year, 4 year

Composite of major adverse events (MAEs) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 6 months, 1 year and annually thereafter. The outcome is analyzed as the count and percentage of participants with events at each timepoint.

6 months

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	16

1 year

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	23

2 year (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	26

3 year (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	33

4 years (site-reported)

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	45

LVEDV by Study Visit Secondary · Baseline, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years

Left ventricular end diastolic volume (LVEDV) by study visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Baseline Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	181.2	± 60.8

6-Month Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	166.2	± 61.3

1-Year Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	152.8	± 55.6

2-Year Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	145.9	± 58.5

3-Year Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	151.3	± 66.1

4-Year Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	141.2	± 63.3

Change in LVEDV, Baseline to 6-Month Visit Secondary · Baseline and 6 Months

Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 6-Month visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Baseline Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	187.3	± 60.9

6-Month Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	169.9	± 61.1

Change from Baseline

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	-17.4	± 30.5

Change in LVEDV, Baseline to 1-Year Visit Secondary · Baseline and 1 Year

Change in left ventricular end diastolic volume (LVEDV) from the Baseline to the 1-Year visit, measured by independent echocardiographic core lab review of transthoracic echocardiography (TTE) imaging

Baseline Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	178.0	± 61.5

1-Year Visit

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	153.3	± 54.3

Change from Baseline

Group	Value	95% CI
Edwards PASCAL Transcatheter Mitral Valve Repair System	-24.6	± 34.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 year follow up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Edwards PASCAL Transcatheter Mitral Valve Repair System

Serious: 94/124 (76%)

Deaths: 45/124

Serious adverse events (152 terms)

Reaction	System	Edwards PASCAL Transcathet…
Cardiac failure	Cardiac disorders	—
Acute kidney injury	Renal and urinary disorders	—
Atrial fibrillation	Cardiac disorders	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—
Anaemia	Blood and lymphatic system disorders	—
Cardiac failure acute	Cardiac disorders	—
Pneumonia	Infections and infestations	—
Cardiac failure congestive	Cardiac disorders	—
Hypotension	Vascular disorders	—
Cardiac arrest	Cardiac disorders	—
Mitral valve incompetence	Cardiac disorders	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Sepsis	Infections and infestations	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Urinary tract infection	Infections and infestations	—
COVID-19	Infections and infestations	—
Chest pain	General disorders	—
Device dislocation	Product Issues	—
Cardiogenic shock	Cardiac disorders	—
Acute myocardial infarction	Cardiac disorders	—
Renal failure	Renal and urinary disorders	—
Urinary retention	Renal and urinary disorders	—
Acute left ventricular failure	Cardiac disorders	—
Dehydration	Metabolism and nutrition disorders	—
Cerebrovascular accident	Nervous system disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	Edwards PASCAL Transcathet…
Atrial fibrillation	Cardiac disorders	—
Cardiac failure	Cardiac disorders	—
Urinary tract infection	Infections and infestations	—
Acute kidney injury	Renal and urinary disorders	—
Hypotension	Vascular disorders	—

Most-reported serious reactions: Cardiac failure, Acute kidney injury, Atrial fibrillation, Gastrointestinal haemorrhage, Anaemia, Cardiac failure acute, Pneumonia, Cardiac failure congestive.

Data from ClinicalTrials.gov NCT03170349 adverse events section.

Sponsor's own description

The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

Publications & conference data

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

Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study.
Lim DS, Kar S, Spargias K, Kipperman RM, et al · · 2019 · cited 105× · PMID 31255562 · DOI 10.1016/j.jcin.2019.04.034
1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study.
Webb JG, Hensey M, Szerlip M, Schäfer U, et al · · 2020 · cited 62× · PMID 33092709 · DOI 10.1016/j.jcin.2020.06.019
Complications Following Percutaneous Mitral Valve Repair.
Gheorghe L, Ielasi A, Rensing BJWM, Eefting FD, et al · · 2019 · cited 32× · PMID 31681798 · DOI 10.3389/fcvm.2019.00146
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
Mortality and Clinical Predictors After Percutaneous Mitral Valve Repair for Secondary Mitral Regurgitation: A Systematic Review and Meta-Regression Analysis.
Shi W, Zhang W, Zhang D, Ye G, et al · · 2022 · cited 4× · PMID 35859589 · DOI 10.3389/fcvm.2022.918712
Transcatheter interventions for functional mitral regurgitation.
Chancellor WZ, Schubert SA, Ailawadi G. · · 2018 · cited 3× · PMID 30598890 · DOI 10.21037/acs.2018.09.01

Verify or expand the search:

Other recruiting trials for Mitral Valve Regurgitation

Currently open trials in the same condition.

NCT07520656 — Impact of Transcatheter Aortic Valve Implantation and Mitral Valve Repair on Sleep-Disordered Breathing · recruiting
NCT05455489 — GISE Registry of Transcatheter Treatment of Mitral Valve Regurgitation With the MitraClip G4 · recruiting
NCT05051033 — Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) · NA · recruiting
NCT04818502 — Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation · active not recruiting
NCT04775108 — First-In-Human Clinical Study for Treatment of Severe Mitral Valve INsufficiency With Epygon™ TRanscatheter Mitral VAlve · NA · recruiting

Other Edwards Lifesciences trials

Trials by the same sponsor.

NCT07317648 — ClearSight NextGen1 Study · NA · completed
NCT06833476 — TTVR STRONG Under Coverage With Evidence Development (CED) Study · recruiting
NCT06569602 — Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) · recruiting
NCT06834516 — ClearSight Baby Cuff · completed
NCT05957406 — SMART TRENDS Study · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03170349 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Edwards Lifesciences
Last refreshed: 5 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03170349.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03170349: CLASP

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (152 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Mitral Valve Regurgitation

Other Edwards Lifesciences trials

Verify against primary sources