NCT04128384 - 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)

Gaede L, Kim WK, Liebetrau C, Dörr O, Sperzel J, Blumenstein J, Berkowitsch A, Walther T, Hamm C, Elsässer A, Nef H, Möllmann H
Pacemaker implantation after TAVI: predictors of AV block persistence. Clin Res Cardiol. 2018 Jan;107(1):60-69. doi: 10.1007/s00392-017-1158-2. Epub 2017 Sep 29.
Nazif TM, Williams MR, Hahn RT, Kapadia S, Babaliaros V, Rodés-Cabau J, Szeto WY, Jilaihawi H, Fearon WF, Dvir D, Dewey TM, Makkar RR, Xu K, Dizon JM, Smith CR, Leon MB, Kodali SK
Clinical implications of new-onset left bundle branch block after transcatheter aortic valve replacement: analysis of the PARTNER experience. Eur Heart J. 2014 Jun 21;35(24):1599-607. doi: 10.1093/eurheartj/eht376. Epub 2013 Oct 30.
Urena M, Mok M, Serra V, Dumont E, Nombela-Franco L, DeLarochellière R, Doyle D, Igual A, Larose E, Amat-Santos I, Côté M, Cuéllar H, Pibarot P, de Jaegere P, Philippon F, Garcia del Blanco B, Rodés-Cabau J
Predictive factors and long-term clinical consequences of persistent left bundle branch block following transcatheter aortic valve implantation with a balloon-expandable valve. J Am Coll Cardiol. 2012 Oct 30;60(18):1743-52. doi: 10.1016/j.jacc.2012.07.035. Epub 2012 Oct 3.

Changes in Infranodal Conduction Times and New Onset Left Bundle Branch Block: Possible Predictors for High-grade AV Block Following Transcatheter Aortic Valve Replacement

Details for clinical trial NCT04128384

Clinical trial NCT04128384 - References