Trial Outcomes & Findings for Cardiovalve Transfemoral Mitral Valve System (NCT NCT03813524)

Last Updated: 2026-06-25

Results Overview

1. Successful access, delivery and retrieval of the delivery system; and 2. Successful deployment and correct positioning of the first intended implant; and 3. Freedom from emergency surgery or reintervention related to the device or access procedure Without any procedural mortality, stroke, and device dysfunction (Central MR grade \> 1 or paravalvular leak moderate or severe, mean mitral gradient \> 6 mm Hg, LVOT obstruction (gradient increase ≥10 mm Hg)) at 30-day follow up.

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

30 Days

Results posted on

2026-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cardiovalve Transfemoral Mitral Valve Replacement valve delivered through a transfemoral access and transseptal approach Cardiovalve Transfemoral Mitral Valve: The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cardiovalve Transfemoral Mitral Valve System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiovalve Transfemoral Mitral Valve n=1 Participants Replacement valve delivered through a transfemoral access and transseptal approach Cardiovalve Transfemoral Mitral Valve: The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Age, Continuous	1 years STANDARD_DEVIATION 0 • n=20 Participants
Sex: Female, Male Female	0 Participants n=20 Participants
Sex: Female, Male Male	1 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	1 Participants n=20 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants
Region of Enrollment United States	1 Participants n=20 Participants

PRIMARY outcome

Timeframe: 30 Days

Outcome measures

Outcome measures
Measure	Cardiovalve Transfemoral Mitral Valve n=1 Participants Replacement valve delivered through a transfemoral access and transseptal approach Cardiovalve Transfemoral Mitral Valve: The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
Number of Participants With Cardiovalve Technical Success	1 Participants

PRIMARY outcome

Timeframe: 30 Days

1. Death (Cardiovascular mortality vs non-cardiovascular); 2. Reintervention (operative or transcatheter) due to progressive or recurrent MR or device related complications; 3. Disabling Stroke; 4. Myocardial infarction (MVARC definition); 5. Major access site and vascular complications 6. Fatal or Life-threatening bleeding (MVARC Type III- V) 7. Life-threatening arrhythmia; 8. Renal Failure requiring dialysis;

Outcome measures

Outcome measures
Measure	Cardiovalve Transfemoral Mitral Valve n=1 Participants Replacement valve delivered through a transfemoral access and transseptal approach Cardiovalve Transfemoral Mitral Valve: The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
Number of Participants With Major Device Related Adverse Events Through 30 Days	1 Participants

Adverse Events

Cardiovalve Transfemoral Mitral Valve

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cardiovalve Transfemoral Mitral Valve n=1 participants at risk Replacement valve delivered through a transfemoral access and transseptal approach Cardiovalve Transfemoral Mitral Valve: The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	100.0% 1/1 • Number of events 2 • 3 months from participant enrollment through participant death/exit from the study.
Infections and infestations Fever	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Renal and urinary disorders Urinary Retention	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
General disorders Gout	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Elevated Mitral Mean Gradient	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Worsening Heart Failure	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Renal and urinary disorders Acute Kidney Injury	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Atrial Fibrilation	100.0% 1/1 • Number of events 3 • 3 months from participant enrollment through participant death/exit from the study.
Blood and lymphatic system disorders Hypertension	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Product Issues Device Thrombosis	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Low Cardiac Output	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Cardiogenic shock	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Mitral Valve Senosis	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Respiratory, thoracic and mediastinal disorders Right Pneumothorax	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.

Other adverse events

Other adverse events
Measure	Cardiovalve Transfemoral Mitral Valve n=1 participants at risk Replacement valve delivered through a transfemoral access and transseptal approach Cardiovalve Transfemoral Mitral Valve: The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
Cardiac disorders Ventricular tachycardia	100.0% 1/1 • Number of events 2 • 3 months from participant enrollment through participant death/exit from the study.
General disorders Decreased Appetite	100.0% 1/1 • Number of events 2 • 3 months from participant enrollment through participant death/exit from the study.
General disorders Weakness	100.0% 1/1 • Number of events 3 • 3 months from participant enrollment through participant death/exit from the study.
Hepatobiliary disorders Elevated Liver Enzymes	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Infections and infestations UTI	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Endocrine disorders Hypoglycemia	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Blood and lymphatic system disorders leukocytosis	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
General disorders Right Foot and leg anterior wounds	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Respiratory, thoracic and mediastinal disorders Pneumonia	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
General disorders Pressure injury of the mouth	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Blood and lymphatic system disorders Hyponatremia	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Renal and urinary disorders Acute Kidney Injury	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Blood and lymphatic system disorders Thrombocytopenia	100.0% 1/1 • Number of events 2 • 3 months from participant enrollment through participant death/exit from the study.
Hepatobiliary disorders Increased INR	100.0% 1/1 • Number of events 2 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Worsening Tricuspid Regurgitation	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Reduced LV Function	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • Number of events 4 • 3 months from participant enrollment through participant death/exit from the study.
General disorders Gluteal midline wound	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Infections and infestations Fever	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Psychiatric disorders Depression	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Respiratory, thoracic and mediastinal disorders Pleural effusions	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Cardiac disorders Arrythmia	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.
Infections and infestations Blood infection	100.0% 1/1 • Number of events 1 • 3 months from participant enrollment through participant death/exit from the study.

Additional Information

Lauren Baker

Insight Medical

Phone: 978-764-3434

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place