NCT04770142 - Clinical Trial References

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.

Citation(s)

Shin ES, Chon MK, Jun EJ, Park YH, Lee SH, Kim JS, Shin DH, Lee SY, Cho MS, Lee SW, Reinthaler M, Park JW, Nam GB, Lederman RJ, Won Y, Kim JH
Septal Reduction Using Transvenous Intramyocardial Cerclage Radiofrequency Ablation: Preclinical Feasibility. JACC Basic Transl Sci. 2020 Sep 30;5(10):988-998. doi: 10.1016/j.jacbts.2020.08.006. eCollection 2020 Oct.

The Study for Evaluation of Safety and Efficacy of Transcatheter RF Ablation System (TIRA Catheter) to Treat Hypertrophic Obstructive Cardiomyopathy : Multi-center, Open Label, Single Arm, Investigator Initiated Exploratory Pilot Study

Details for clinical trial NCT04770142

Clinical trial NCT04770142 - References