SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
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|ClinicalTrials.gov Identifier: NCT04464876|
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : July 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Mitral Regurgitation Valve Heart Disease Heart Valve Diseases Mitral Valve Disease Mitral Disease||Device: SATURN TA System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||July 2022|
SATURN TA TMVR Device implanted
Device: SATURN TA System
SATURN TA TMVR Device implanted
- Freedom from device-related or procedure-related major adverse events [ Time Frame: 30 days ]Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).
- Reduction of mitral regurgitation [ Time Frame: 30 days ]Reduction of mitral regurgitation to ≤1 at 30 days.
- Technical success [ Time Frame: Day 0 ]
Technical success defined as alive patient at exit from procedure room, with all of the following:
- Successful access, delivery and retrieval of the delivery systems.
- Development and correct positioning of the bioprosthesis.
- Freedom of additional emergency surgery or re-intervention related to the device or access procedure.
- Freedom from device-related or procedure-related major adverse events [ Time Frame: 30 days, 1 year, 2 years ]
- Freedom from device-related or procedure-related major adverse events throughout long- term follow-up.
- Freedom from all-cause mortality
- Freedom from all-cause mortality [ Time Frame: 30 days, 1 year, 2 years ]Freedom from all-cause mortality
- Patients success [ Time Frame: 30 days, 1 year, 2 years ]Patients success
- Device success [ Time Frame: 30 days, 1 year, 2 years ]Device success
- 6 Minute Hall Walk Test [ Time Frame: 30 days, 1 year, 2 years ]Improvement from baseline in functional status by ≥ 30 meters
- KCCQ [ Time Frame: 30 days, 1 year, 2 years ]Improvement from baseline in Quality of Life by ≥ 10 points.
- NYHA functional classification [ Time Frame: 30 days, 1 year, 2 years ]Improvement from baseline by ≥ 1 functional classification.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464876
|Contact: Carrie Vooghtfirstname.lastname@example.org|
|Lithuanian University of Health Sciences||Recruiting|
|Contact: Eglė Rumbinaitė, MD|
|Principal Investigator: Rimantas Benetis, MD, PhD|
|Vilnius University Hospital Santaros klinikos||Recruiting|
|Contact: Andrej Podkopajev, MD|
|Principal Investigator: Kęstutis Ručinskas, MD, PhD|
|Study Director:||Carrie Vooght||InnovHeart|