TVMR With the Innovalve System Trial - Pilot Study in Italy — TWIST-PILOT-IT

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Mitral Valve Regurgitation (Degenerative or Functional) Clinical Trial

Official title:
TVMR With the Innovalve System Trial - Pilot Study in Italy

Status Recruiting

Clinical Trial Summary

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

n/a

NCT number	NCT05010746
Study type	Interventional
Source	Innovalve Bio Medical Ltd.
Contact	Director Clinical Affairs
Phone	+972-3-5308058
Email	clinicaltrials@innovalemed.com
Status	Recruiting
Phase	N/A
Start date	January 1, 2023
Completion date	January 1, 2028

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04919980` - TVMR With the Innovalve System Trial - Early Feasibility Study	Phase 1
Recruiting	`NCT05688514` - TVMR With the Innovalve System Trial - First In Human Israel	N/A
Not yet recruiting	`NCT05263375` - TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE	N/A
Active, not recruiting	`NCT02718001` - Edwards EVOQUE Eos MISCEND Study	N/A
Recruiting	`NCT05682066` - TVMR With the Innovalve System Trial - Pilot in Georgia	N/A