NCT03270124 - 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)

Lindman BR, Gillam LD, Coylewright M, Welt FGP, Elmariah S, Smith SA, McKeel DA, Jackson N, Mukerjee K, Cloud H, Hanna N, Purpura J, Ellis H, Martinez V, Selberg AM, Huang S, Harrell FE
Effect of a Pragmatic Home-Based Mobile Health Exercise Intervention After Transcatheter Aortic Valve Replacement: A Randomized Pilot Trial. European Heart Journal - Digital Health 2021. Published online February 4, 2021. https://doi.org/10.1093/ehjdh/ztab007

A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement (ACTIVE AFTER TAVR): A Pilot Study

Clinical trial NCT03270124 - References