Trial Outcomes & Findings for PARTNER 3 Trial - Mitral Valve in Valve (NCT NCT03193801)

NCT ID: NCT03193801

Last Updated: 2025-11-05

Results Overview

Non-hierarchical composite endpoint of all-cause mortality and stroke at 1-year post-procedure

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 1 Year
• Results posted on: 2025-11-05

Participant Flow

Participant milestones

Measure	Failing Mitral Transcatheter Valve Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Overall Study STARTED	53
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Failing Mitral Transcatheter Valve Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Overall Study Physician Decision	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

PARTNER 3 Trial - Mitral Valve in Valve

Baseline characteristics by cohort

Measure	Failing Mitral Transcatheter Valve n=50 Participants Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Age, Continuous	70.1 years STANDARD_DEVIATION 9.66 • n=15 Participants
Sex: Female, Male Female	27 Participants n=15 Participants
Sex: Female, Male Male	23 Participants n=15 Participants
Race/Ethnicity, Customized Asian	3 Participants n=15 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=15 Participants
Race/Ethnicity, Customized White	31 Participants n=15 Participants
Race/Ethnicity, Customized Other	7 Participants n=15 Participants
Race/Ethnicity, Customized Unknown	5 Participants n=15 Participants
Region of Enrollment United States	34 participants n=15 Participants
Region of Enrollment Brazil	12 participants n=15 Participants
Region of Enrollment Australia	4 participants n=15 Participants

PRIMARY outcome

Timeframe: 1 Year

Population: Valve implant population

Non-hierarchical composite endpoint of all-cause mortality and stroke at 1-year post-procedure

Outcome measures

Measure	Failing Mitral Transcatheter Valve n=50 Participants Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Safety and Effectiveness - Composite of All-cause Mortality and Stroke	0 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Valve implant population - 2 subjects did not complete the 30-day visit.

NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.

A decrease in NYHA class (negative value) shows patient improvement at 30 days.

Outcome measures

Measure	Failing Mitral Transcatheter Valve n=48 Participants Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
New York Heart Association (NYHA) Functional Class - Change From Baseline	-1.4 score on a scale Standard Error 0.73

SECONDARY outcome

Timeframe: 30 days

Population: Valve implant population - 2 subjects did not complete the 30-day visit.

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. An overall summary score can be derived from the physical function, symptom, social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

An increase in KCCQ score (positive value) shows patient improvement at 30 days.

Outcome measures

Measure	Failing Mitral Transcatheter Valve n=48 Participants Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Kansas City Cardiomyopathy Questionnaire (KCCQ) - Change From Baseline	31.0 score on a scale Standard Error 26.06

SECONDARY outcome

Timeframe: 30 days

Population: Valve implant population - 4 subjects did not receive an echocardiogram at 30 days

Echocardiographic assessment of the degree of mitral valve regurgitation

None=0, Trace=0.5, Mild or Mild-Moderate=1, Moderate=2, Moderate-Severe=3, and Severe=4.

A decrease in MR (negative value) shows patient improvement at 30 days.

Outcome measures

Measure	Failing Mitral Transcatheter Valve n=46 Participants Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Mitral Regurgitation - Change From Baseline	-1.4 score on a scale Standard Error 1.48

SECONDARY outcome

Timeframe: 30 days

Population: Valve implant population - 35 subjects had data at 30 days

Echocardiographic assessment of pulmonary artery systolic pressure

A decrease in pulmonary artery systolic pressure (negative value) shows patient improvement at 30 days.

Outcome measures

Measure	Failing Mitral Transcatheter Valve n=35 Participants Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Pulmonary Artery Systolic Pressure - Change From Baseline	-9.5 mmHg Standard Error 14.64

Adverse Events

Failing Mitral Transcatheter Valve

Serious events: 21 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Failing Mitral Transcatheter Valve n=50 participants at risk Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Infections and infestations Urinary tract infection	2.0% 1/50 • Number of events 1 • 1 Year
Injury, poisoning and procedural complications Femur fracture	2.0% 1/50 • Number of events 1 • 1 Year
Injury, poisoning and procedural complications Rib fracture	2.0% 1/50 • Number of events 1 • 1 Year
Injury, poisoning and procedural complications Spinal compression fracture	2.0% 1/50 • Number of events 1 • 1 Year
Injury, poisoning and procedural complications Vascular access site haemorrhage	4.0% 2/50 • Number of events 2 • 1 Year
Injury, poisoning and procedural complications Vascular pseudoaneurysm thrombosis	2.0% 1/50 • Number of events 1 • 1 Year
Investigations Transvalvular pressure gradient increased	2.0% 1/50 • Number of events 1 • 1 Year
Investigations Troponin increased	2.0% 1/50 • Number of events 1 • 1 Year
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.0% 1/50 • Number of events 1 • 1 Year
Product Issues Device deployment issue	2.0% 1/50 • Number of events 1 • 1 Year
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.0% 1/50 • Number of events 1 • 1 Year
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.0% 1/50 • Number of events 1 • 1 Year
Skin and subcutaneous tissue disorders Ecchymosis	2.0% 1/50 • Number of events 1 • 1 Year
Vascular disorders Arterial thrombosis	2.0% 1/50 • Number of events 1 • 1 Year
Vascular disorders Haematoma	2.0% 1/50 • Number of events 1 • 1 Year
Cardiac disorders Angina pectoris	2.0% 1/50 • Number of events 1 • 1 Year
Cardiac disorders Aortic valve incompetence	2.0% 1/50 • Number of events 1 • 1 Year
Cardiac disorders Atrial fibrillation	4.0% 2/50 • Number of events 2 • 1 Year
Cardiac disorders Atrial tachycardia	2.0% 1/50 • Number of events 1 • 1 Year
Cardiac disorders Bradycardia	2.0% 1/50 • Number of events 1 • 1 Year
Cardiac disorders Cardiac failure	4.0% 2/50 • Number of events 2 • 1 Year
Cardiac disorders Cardiac failure congestive	4.0% 2/50 • Number of events 2 • 1 Year
Cardiac disorders Sinus node dysfunction	2.0% 1/50 • Number of events 1 • 1 Year
Cardiac disorders Ventricular fibrillation	2.0% 1/50 • Number of events 1 • 1 Year
Gastrointestinal disorders Gastrointestinal haemorrhage	2.0% 1/50 • Number of events 1 • 1 Year
Gastrointestinal disorders Small intestinal haemorrhage	2.0% 1/50 • Number of events 1 • 1 Year
General disorders Prosthetic cardiac valve thrombosis	2.0% 1/50 • Number of events 1 • 1 Year
Infections and infestations Cellulitis	2.0% 1/50 • Number of events 1 • 1 Year
Infections and infestations Myelitis	2.0% 1/50 • Number of events 1 • 1 Year
Infections and infestations Suspected COVID-19	2.0% 1/50 • Number of events 1 • 1 Year

Other adverse events

Measure	Failing Mitral Transcatheter Valve n=50 participants at risk Patients with a failing bioprosthetic valve in the mitral position demonstrating stenosis and/or insufficiency will be treated with Edwards SAPIEN 3 transcatheter valve.
Blood and lymphatic system disorders Anaemia	6.0% 3/50 • Number of events 3 • 1 Year
Cardiac disorders Atrial fibrillation	6.0% 3/50 • Number of events 3 • 1 Year
Cardiac disorders Atrioventricular block first degree	6.0% 3/50 • Number of events 3 • 1 Year
General disorders Prosthetic cardiac valve stenosis	6.0% 3/50 • Number of events 3 • 1 Year
Infections and infestations Upper respiratory tract infection	6.0% 3/50 • Number of events 3 • 1 Year
Injury, poisoning and procedural complications Anaemia postoperative	6.0% 3/50 • Number of events 3 • 1 Year
Renal and urinary disorders Acute kidney injury	6.0% 3/50 • Number of events 3 • 1 Year

Additional Information

Director of Research

Edwards Lifesciences

Phone: 949-250-2500

Email: THV_ct.gov@edwards.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place