Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

NCT06414265 | Recruiting DMC

• 1 other identifier: TP-0181
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate feasibility, safety, and performance of the SATURN TS TMVR System for the treatment of moderate-to-severe or severe, symptomatic mitral regurgitation through a transcatheter approach. The main questions it aims to answer are:

• is the use of the device feasible?
• is it safe (defined as freedom from device-related major adverse events at 30 days)?
• does it perform (defined as reduction of MR Grade to ≤ 1+ at 30 days)? Participants will need to do the following as part of the clinical trial:
• complete 6-Minute Walking Test
• complete Quality of Life Questionnaires
• undergo blood evaluations
• CT scan
• 12 lead ECG
• Transesophageal Echocardiography
• Transthoracic Echocardiogram
• the study procedure (valve implantation, right heart catheterization, left arterial pressure, fluoroscopy/ angiogram)

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Safety Endpoint - Freedom from Device Related Major Adverse Events

  Freedom from device-related major adverse events

  30 days post-procedure

• Technical Procedural Success Endpoint

  Technical success defined as alive patient at exit from procedure room with all the following: * Successful access, delivery of the SATURN TS Bioprosthesis, and retrieval of the TS Delivery Systems * Correct positioning of the first intended SATURN TS Bioprosthesis * Freedom from emergency surgery or mitral valve re-intervention related to the device or access procedure

  Procedure

• Efficacy Endpoint - Reduction of Mitral Regurgitation Grade to ≤ 1+

  Reduction of MR Grade to ≤ 1+

  30 days post-procedure

Study Arms (1)

Treatment Arm

EXPERIMENTAL

SATURN Trans-septal Transcatheter mitral valve replacement (TMVR) System

Device: Transcatheter mitral valve replacement

Interventions

Transcatheter mitral valve replacement DEVICE

The SATURN TS TMVR System will be implanted through a transcatheter approach in patients with symptomatic mitral regurgitation.

Treatment Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older.
• Symptomatic moderate to severe or severe functional mitral regurgitation (≥ Grade 3+).
• NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
• Ability to tolerate oral anticoagulation.
• Ability to qualify for bailout surgery (which may include open heart surgery).
• High risk for open-heart mitral valve surgery due to age, co-morbidities or frailty, as determined by the Heart Team.
• Willing and able to complete study-related assessments and questionnaires.

You may not qualify if:

• Degenerative (i.e. intrinsic valve lesions) mitral regurgitation.
• Excessive frailty or comorbid conditions that preclude the anticipated benefit of the mitral valve replacement.
• Life expectancy \<1 year due to noncardiac conditions.
• Endocarditis in the 3 months prior to procedure date.
• Current admission with acute heart failure exacerbation.
• Dependency on inotropic agents or mechanical circulatory support.
• Untreated clinically significant CAD.
• Active systemic infection.
• Modified Rankin Scale ≥4 disability.
• Chronic renal failure defined as eGFR \<30 mL/min/m2 or on renal replacement therapy.
• Severe pulmonary arterial hypertension (PAH), defined as PASP \> 60mmHg.
• Platelets \< 90,000.
• COPD 2 on home oxygen therapy deemed too high risk for intubation.
• Refuses blood transfusions.
• Documented bleeding or coagulation disorders (hypo- or hyper-coagulable states).

Sponsors & Collaborators

• InnovHeart: lead
• Avania: collaborator

Study Sites (3)

Tbilisi Heart and Vascular Clinic

Tbilisi, Georgia

RECRUITING

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

RECRUITING

Warsaw Medical University

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Paolo Denti, MD

  San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VP, Clinical Affairs InnovHeart

CONTACT

+49 69 24003626; a.roach@innovheart.com

Maxis Operations

CONTACT

maxisoperations@maxismedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 16, 2024
• Study Start: April 4, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): February 1, 2030
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); GE (1); LI (1)