NCT05714800 - 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)

Badhwar V, Rankin JS, Damiano RJ Jr, Gillinov AM, Bakaeen FG, Edgerton JR, Philpott JM, McCarthy PM, Bolling SF, Roberts HG, Thourani VH, Suri RM, Shemin RJ, Firestone S, Ad N
The Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation. Ann Thorac Surg. 2017 Jan;103(1):329-341. doi: 10.1016/j.athoracsur.2016.10.076.
Kornej J, Borschel CS, Benjamin EJ, Schnabel RB
Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340. Epub 2020 Jun 18.
Lippi G, Sanchis-Gomar F, Cervellin G
Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum In: Int J Stroke. 2020 Jan 28;:1747493020905964.
McCarthy PM, Kruse J, Shalli S, Ilkhanoff L, Goldberger JJ, Kadish AH, Arora R, Lee R
Where does atrial fibrillation surgery fail? Implications for increasing effectiveness of ablation. J Thorac Cardiovasc Surg. 2010 Apr;139(4):860-7. doi: 10.1016/j.jtcv
McClure GR, Belley-Cote EP, Jaffer IH, Dvirnik N, An KR, Fortin G, Spence J, Healey J, Singal RK, Whitlock RP
Surgical ablation of atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials. Europace. 2018 Sep 1;20(9):1442

Endocardial Mapping of Left Atrium for Evaluation of Concomitant Surgical Ablation Lesions for Treatment of Atrial Fibrillation

Clinical trial NCT05714800 - References