The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study

• Sponsor: Edwards Lifesciences (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03170349
• Collaborator: (none)
• Enrollment: 124
• Locations: 17
• Arm: 1
• Anticipated Duration (Months): 97.1
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mitral Valve Regurgitation	Device: Mitral Valve Repair	N/A

Detailed 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. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
• Actual Study Start Date: Jun 27, 2017
• Actual Primary Completion Date: Jul 30, 2020
• Anticipated Study Completion Date: Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System	Device: Mitral Valve Repair; Minimal Invasive Transcatheter Mitral Valve Repair

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Major Adverse Events (MAE) [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

2. Device Success [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.

3. Number of Participants With Procedural Success [through discharge]

   Device success with evidence of mitral regurgitation reduction ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed per independent echocardiography core laboratory.

4. Clinical Success [30 days]

   Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs at 30 days. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.

Secondary Outcome Measures

1. Mitral Regurgitation Reduction [baseline, 30 days, 6 months, 1 year]

   Mitral regurgitation reduction at 30 days, 6 months, and 1 year over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.

2. All-cause Mortality [30 days, 6 months, 1 year]

   All-cause mortality at 30 days, 6 months, 1 year

3. Recurrent Heart Failure Hospitalization [30 days , 6 months, 1 year]

   Recurrent heart failure hospitalization at 30 days, 6 months, 1 year

4. Re-intervention Rates for Mitral Regurgitation [30 days, 6 months and 1 year]

   Re-intervention rates for mitral regurgitation at 30 days, 6 months, 1 year

5. 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 [6 months, 1 year]

   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 6 months, 1 year and annually thereafter

6. Change in Left Ventricular End Diastolic Volume (LVEDV) [6 months, 1 year]

   Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months, and 1 year over baseline

7. Change in Left Ventricular End Systolic Volume (LVESV) [6 months, 1 year]

   Change in Left Ventricular End Systolic Volume (LVESV) at 6 months and 1 year over baseline

8. Change in Pulmonary Artery Systolic Pressure [baseline, 6 months, 1 year]

   Change in Pulmonary Artery Systolic Pressure at 6 months, and 1 year over baseline

9. Change in Six Minute Walk Test (6MWT) Distance [6 months, 1 year]

   Mean distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months, and 1 year compared to baseline

10. Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) [baseline, 30 days, 6 months, 1 year]

    Mean KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.

11. Change in Quality of Life (QoL) Score, as Measured by EQ5D [baseline, 30 days, 6 months, 1 year]

    Change in Quality of Life (QoL) score, as measured by EQ5D at 30 days, 6 months over baseline. The EQ5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life.

12. Change in NYHA Functional Classification [baseline, 6 months, 1 year]

    Change in NYHA Functional Classification at 6 months and 1 year over baseline. NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.

13. Change NT-pro-BNP Level [baseline, 6 months, 1 year]

    Change in NT-pro-BNP level at 6 months and 1 year over baseline

14. Change in BNP Level [baseline, 6 months, 1 year]

    Change in BNP level at 6 months over baseline

15. Change in Tricuspid Regurgitation (TR) [6 months, 1 year]

    Change in TR over baseline at 6 months, and 1 year. TR grade was assessed by an independent echocardiography core lab using a 6-grade scale: None, trace, mild, mild-moderate, moderate-severe, or severe. Reduction by 1 or more grades reflects improvement from baseline, while an increase by 1 or more grades reflects worsening of TR.

16. Change in Effective Regurgitant Orifice Area (EROA) [baseline, 30 days, 6 months, 1 year]

    Change in effective regurgitant orifice area (EROA) at 30 days, 6 months, and 1 year over baseline

17. Change in Mitral Regurgitant Volume [baseline, 30 days, 6 months, 1 year]

    Change in mitral regurgitant volume at 30 days, 6 months and 1 year over baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed and dated IRB/ethics committee approved study consent form prior to study related procedures

• Eighteen (18) years of age or older

• New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy

• Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation

• Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).

• The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.

• Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.

Exclusion Criteria:

• Patient in whom a TEE is contraindicated or screening TEE is unsuccessful

• Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.

• Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)

• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation

• Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction

• Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator

• Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment

• Patient is under guardianship

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	University of Colorado Denver	Aurora	Colorado	United States	80045
3	NorthShore University HealthSystem	Evanston	Illinois	United States	60201
4	Henry Ford Hospital	Detroit	Michigan	United States	48202
5	Morristown Medical Center	Morristown	New Jersey	United States	07960
6	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
7	The Heart Hospital Baylor Plano	Plano	Texas	United States	75093
8	University of Virginia Health System	Charlottesville	Virginia	United States	22908
9	Metro North Hospital & Health Service, The Prince Charles Hospital	Brisbane	Chermside	Australia	QLD 4032
10	Sydney Local Health District, Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
11	St. Paul's Hospital, Providence Health Care Research Institute	Vancouver	British Columbia	Canada	V6E 1M7
12	Sunnybrook Hospital	Toronto	Ontario	Canada	M4N 3M5
13	St Michael Hospital	Toronto	Ontario	Canada	M5B-1W8
14	Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie	Bonn		Germany	53127
15	Hygeia Hospital	Athens		Greece	15123
16	San Rafaelle Hospital	Milano		Italy	20132
17	Inselspital, University Hospital Bern	Bern		Switzerland	3010

Sponsors and Collaborators

• Edwards Lifesciences

Investigators

• Principal Investigator: Gideon Cohen, MD, Sunnybrook Hospital
• Principal Investigator: Ulrich Schafer, MD, Bundeswehrzentralkrankenhaus Koblenz
• Principal Investigator: Molly Szerlip, MD, The Heart Hospital Baylor

Study Documents (Full-Text)

• Study Protocol - Aug 20, 2018
• Statistical Analysis Plan - Aug 21, 2018

More Information

Publications

None provided.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT03170349
• Other Study ID Numbers: 2016-05
• First Posted: May 31, 2017
• Last Update Posted: Aug 23, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Mitral Valve Insufficiency

Study Results

Participant Flow

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Period Title: At 30 Days Follow-up
STARTED	124
COMPLETED	123
NOT COMPLETED	1
Period Title: At 30 Days Follow-up
STARTED	123
COMPLETED	114
NOT COMPLETED	9
Period Title: At 30 Days Follow-up
STARTED	114
COMPLETED	106
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Overall Participants	124
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.9 (11.2)
Sex: Female, Male (Count of Participants)
Female	55 44.4%
Male	69 55.6%
Race and Ethnicity Not Collected (Count of Participants)
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	66.7 (4.1)
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	165.4 (34.0)
Body Mass Index (kilogram/meter square) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram/meter square]	26.2 (4.9)
Tobacco Use (Count of Participants)
Current daily smoker	4 3.2%
Former daily smoker	63 50.8%
Never	57 46%
EuroSCORE II (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	5.8 (5.4)
STS Mortality Score (Units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Units on a scale]	4.6 (3.3)
NYHA Class (Count of Participants)
Class I	0 0%
Class II	49 39.5%
Class III	68 54.8%
Class IV	6 4.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Major Adverse Events (MAE)
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Count of Participants [Participants]	10 8.1%

2. Primary Outcome

Title	Device Success
Description	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.
Time Frame	Exit from the cardiac catheterization laboratory

Outcome Measure Data

Analysis Population Description

Per device analysis

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Measure Device	189
Count of Units [Device]	175

3. Primary Outcome

Title	Number of Participants With Procedural Success
Description	Device success with evidence of mitral regurgitation reduction ≤ MR2+ at discharge and without the need for a surgical or percutaneous intervention prior to hospital discharge. Mitral regurgitation was assessed per independent echocardiography core laboratory.
Time Frame	through discharge

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	122
Count of Participants [Participants]	115 92.7%

4. Primary Outcome

Title	Clinical Success
Description	Procedural success with evidence of MR reduction ≤ MR2+ and without MAEs at 30 days. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	121
Count of Participants [Participants]	105 84.7%

5. Secondary Outcome

Title	Mitral Regurgitation Reduction
Description	Mitral regurgitation reduction at 30 days, 6 months, and 1 year over baseline. Mitral regurgitation reduction was assessed per independent echocardiography core laboratory.
Time Frame	baseline, 30 days, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
None/Trace	0 0%
Mild	1 0.8%
Mild-Moderate	0 0%
Moderate-Severe	66 53.2%
Severe	57 46%
None/Trace	18 14.5%
Mild	72 58.1%
Mild-Moderate	23 18.5%
Moderate-Severe	2 1.6%
Severe	2 1.6%
None/Trace	17 13.7%
Mild	64 51.6%
Mild-Moderate	28 22.6%
Moderate-Severe	2 1.6%
Severe	0 0%
None/Trace	13 10.5%
Mild	57 46%
Mild-Moderate	22 17.7%
Moderate-Severe	0 0%
Severe	0 0%

6. Secondary Outcome

Title	All-cause Mortality
Description	All-cause mortality at 30 days, 6 months, 1 year
Time Frame	30 days, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
30 days	1 0.8%
6 months	4 3.2%
1 year	10 8.1%

7. Secondary Outcome

Title	Recurrent Heart Failure Hospitalization
Description	Recurrent heart failure hospitalization at 30 days, 6 months, 1 year
Time Frame	30 days , 6 months, 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
30 days	3 2.4%
6 months	10 8.1%
1 year	15 12.1%

8. Secondary Outcome

Title	Re-intervention Rates for Mitral Regurgitation
Description	Re-intervention rates for mitral regurgitation at 30 days, 6 months, 1 year
Time Frame	30 days, 6 months and 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
30 days	1 0.8%
6 months	2 1.6%
1 year	2 1.6%

9. Secondary Outcome

Title	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
Description	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 6 months, 1 year and annually thereafter
Time Frame	6 months, 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
6 months	16 12.9%
1 year	23 18.5%

10. Secondary Outcome

Title	Change in Left Ventricular End Diastolic Volume (LVEDV)
Description	Change in Left Ventricular End Diastolic Volume (LVEDV) at 6 months, and 1 year over baseline
Time Frame	6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	181.2 (60.8)
6 months	166.2 (61.3)
1 year	152.8 (55.6)

11. Secondary Outcome

Title	Change in Left Ventricular End Systolic Volume (LVESV)
Description	Change in Left Ventricular End Systolic Volume (LVESV) at 6 months and 1 year over baseline
Time Frame	6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	108.7 (55.1)
6 months	100.6 (54.0)
1 year	91.1 (49.4)

12. Secondary Outcome

Title	Change in Pulmonary Artery Systolic Pressure
Description	Change in Pulmonary Artery Systolic Pressure at 6 months, and 1 year over baseline
Time Frame	baseline, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	46.4 (12.6)
6 months	39.7 (11.2)
1 year	39.9 (11.6)

13. Secondary Outcome

Title	Change in Six Minute Walk Test (6MWT) Distance
Description	Mean distance in meters walked during 6 Minute Walk Test (6MWT) at 6 months, and 1 year compared to baseline
Time Frame	6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	265.4 (86.6)
6 months	290.8 (103.3)
1 year	312.4 (104.1)

14. Secondary Outcome

Title	Change in Quality of Life (QoL) Score, as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description	Mean KCCQ Score. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.
Time Frame	baseline, 30 days, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	54.6 (21.3)
30 days	70.7 (17.8)
6 months	71.7 (15.3)
1 year	72.0 (16.7)

15. Secondary Outcome

Title	Change in Quality of Life (QoL) Score, as Measured by EQ5D
Description	Change in Quality of Life (QoL) score, as measured by EQ5D at 30 days, 6 months over baseline. The EQ5D self-reported questionnaire includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher health-related quality of life.
Time Frame	baseline, 30 days, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	62.8 (21.7)
30 days	74.3 (19.6)
6 months	75.1 (17.6)
1 year	73.4 (20.3)

16. Secondary Outcome

Title	Change in NYHA Functional Classification
Description	Change in NYHA Functional Classification at 6 months and 1 year over baseline. NYHA Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity. Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.
Time Frame	baseline, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Class I	0 0%
Class II	49 39.5%
Class III	68 54.8%
Class IV	6 4.8%
Class I	49 39.5%
Class II	52 41.9%
Class III	9 7.3%
Class IV	1 0.8%
Class I	44 35.5%
Class II	48 38.7%
Class III	10 8.1%
Class IV	0 0%

17. Secondary Outcome

Title	Change NT-pro-BNP Level
Description	Change in NT-pro-BNP level at 6 months and 1 year over baseline
Time Frame	baseline, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	4148.7 (6430.8)
6 months	2835.0 (3817.8)
1 year	2620.2 (3061.1)

18. Secondary Outcome

Title	Change in BNP Level
Description	Change in BNP level at 6 months over baseline
Time Frame	baseline, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	839.5 (904.4)
6 months	588.0 (734.8)
1 year	569.3 (923.8)

19. Secondary Outcome

Title	Change in Tricuspid Regurgitation (TR)
Description	Change in TR over baseline at 6 months, and 1 year. TR grade was assessed by an independent echocardiography core lab using a 6-grade scale: None, trace, mild, mild-moderate, moderate-severe, or severe. Reduction by 1 or more grades reflects improvement from baseline, while an increase by 1 or more grades reflects worsening of TR.
Time Frame	6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available.

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	109
3 Grade Increase	0 0%
2 Grade Increase	1 0.8%
1 Grade Increase	14 11.3%
No Change	58 46.8%
1 Grade Reduction	35 28.2%
2 Grade Reduction	1 0.8%
3 Grade Increase	1 0.8%
2 Grade Increase	1 0.8%
1 Grade Increase	8 6.5%
No Change	49 39.5%
1 Grade Reduction	30 24.2%
2 Grade Reduction	2 1.6%

20. Secondary Outcome

Title	Change in Effective Regurgitant Orifice Area (EROA)
Description	Change in effective regurgitant orifice area (EROA) at 30 days, 6 months, and 1 year over baseline
Time Frame	baseline, 30 days, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	0.38 (0.15)
30 days	0.17 (0.21)
6 months	0.15 (0.06)
1 year	0.18 (0.06)

21. Secondary Outcome

Title	Change in Mitral Regurgitant Volume
Description	Change in mitral regurgitant volume at 30 days, 6 months and 1 year over baseline
Time Frame	baseline, 30 days, 6 months, 1 year

Outcome Measure Data

Analysis Population Description

The outcome is reported where data is available

Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Mitral valve repair with PASCAL implanted via transcatheter procedure
Measure Participants	124
Baseline	57.3 (19.7)
30 days	25.2 (18.7)
6 months	25.3 (11.2)
1 year	30.1 (10.1)

Adverse Events

Time Frame	1 year
Arm/Group Title	Edwards PASCAL Transcatheter Mitral Valve Repair System
Arm/Group Description	Multi-center, prospective study with intra-subject comparisons
All Cause Mortality
	Edwards PASCAL Transcatheter Mitral Valve Repair System
	Affected / at Risk (%)	# Events
Total	10/124 (8.1%)
Serious Adverse Events
	Edwards PASCAL Transcatheter Mitral Valve Repair System
	Affected / at Risk (%)	# Events
Total	57/124 (46%)
Blood and lymphatic system disorders
Anaemia	5/124 (4%)	5
Leukocytosis	1/124 (0.8%)	1
Thrombocytopenia	1/124 (0.8%)	1
Cardiac disorders
Atrial fibrillation	4/124 (3.2%)	5
Atrioventricular block complete	1/124 (0.8%)	1
Cardiac arrest	4/124 (3.2%)	5
Cardiac failure	7/124 (5.6%)	18
Cardiac failure congestive	3/124 (2.4%)	3
Cardiogenic shock	3/124 (2.4%)	3
Cardiomyopathy	2/124 (1.6%)	2
Left ventricular failure	1/124 (0.8%)	1
Mitral valve incompetence	2/124 (1.6%)	2
Ventricular tachycardia	2/124 (1.6%)	2
Cardiac failure acute	5/124 (4%)	6
Acute myocardial infarction	1/124 (0.8%)	1
Arrhythmia	1/124 (0.8%)	1
Bradycardia	1/124 (0.8%)	1
Cardiac failure chronic	1/124 (0.8%)	1
Intracardiac thrombus	1/124 (0.8%)	1
Tachycardia	1/124 (0.8%)	1
Gastrointestinal disorders
Dysphagia	2/124 (1.6%)	2
Gastritis	1/124 (0.8%)	1
Gastrointestinal haemorrhage	5/124 (4%)	7
Upper gastrointestinal haemorrhage	3/124 (2.4%)	5
Colitis	1/124 (0.8%)	1
Gallstone ileus	1/124 (0.8%)	1
Pancreatitis acute	1/124 (0.8%)	1
General disorders
Chest pain	3/124 (2.4%)	3
Device embolisation	1/124 (0.8%)	1
Device related thrombosis	1/124 (0.8%)	1
Multiple organ dysfunction syndrome	1/124 (0.8%)	1
Pyrexia	1/124 (0.8%)	1
Hepatobiliary disorders
Portal vein thrombosis	1/124 (0.8%)	1
Infections and infestations
Osteomyelitis	1/124 (0.8%)	1
Pneumonia	2/124 (1.6%)	2
Respiratory tract infection	1/124 (0.8%)	1
Sepsis	2/124 (1.6%)	2
Urinary tract infection	3/124 (2.4%)	3
Arthritis infective	1/124 (0.8%)	1
Bacteraemia	1/124 (0.8%)	1
Septic shock	1/124 (0.8%)	1
Injury, poisoning and procedural complications
Hip Fracture	1/124 (0.8%)	1
Pharyngeal haematoma	1/124 (0.8%)	1
Tongue injury	1/124 (0.8%)	1
Traumatic lung injury	1/124 (0.8%)	1
Urethral injury	1/124 (0.8%)	1
Vascular access site haematoma	1/124 (0.8%)	1
Vascular access site haemorrhage	2/124 (1.6%)	2
Ankle fracture	1/124 (0.8%)	1
Compression fracture	1/124 (0.8%)	1
Fall	1/124 (0.8%)	1
Femoral neck fracture	1/124 (0.8%)	1
Foot fracture	1/124 (0.8%)	1
Joint dislocation	1/124 (0.8%)	1
Pharyngeal injury	1/124 (0.8%)	1
Rib fracture	1/124 (0.8%)	1
Investigations
Transplant evaluation	1/124 (0.8%)	1
Metabolism and nutrition disorders
Dehydration	2/124 (1.6%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm	1/124 (0.8%)	2
Lung neoplasm malignant	1/124 (0.8%)	1
Pleomorphic liposarcoma	1/124 (0.8%)	1
Colon cancer	1/124 (0.8%)	1
Prostate cancer metastatic	1/124 (0.8%)	1
Squamous cell carcinoma	1/124 (0.8%)	1
Nervous system disorders
Ischaemic stroke	2/124 (1.6%)	2
Cerebrovascular accident	1/124 (0.8%)	1
Dementia	1/124 (0.8%)	1
Post stroke epilepsy	1/124 (0.8%)	1
Syncope	1/124 (0.8%)	1
Product Issues
Device dislocation	4/124 (3.2%)	4
Renal and urinary disorders
Acute kidney injury	10/124 (8.1%)	12
Haematuria	1/124 (0.8%)	1
Urinary retention	1/124 (0.8%)	1
Reproductive system and breast disorders
Prostatitis	1/124 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/124 (0.8%)	2
Chronic obstructive pulmonary disease	1/124 (0.8%)	1
Haemoptysis	1/124 (0.8%)	1
Respiratory failure	2/124 (1.6%)	2
Vascular disorders
Shock	1/124 (0.8%)	1
Haematoma	1/124 (0.8%)	1
Hypotension	1/124 (0.8%)	1
Peripheral artery occlusion	1/124 (0.8%)	1
Poor peripheral circulation	1/124 (0.8%)	1
Haemorrhage	1/124 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Edwards PASCAL Transcatheter Mitral Valve Repair System
	Affected / at Risk (%)	# Events
Total	8/124 (6.5%)
Cardiac disorders
Atrial fibrillation	8/124 (6.5%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.