INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT)
Status:
Recruiting
Trial end date:
2022-08-01
Target enrollment:
Participant gender:
Summary
The study consists of 3 parts (Part A, Part B and Part C). Part A was an open-label,
randomized, multi center design to evaluate the feasibility of administration of inhaled
flecainide in two dosing regimens. Part B was an open-label, multicenter design to confirm
the safety (including tolerability) and efficacy of the optimal inhaled flecainide dose
determined from Part A. Part C is currently ongoing and is an open-label, multi center study
with exploratory objectives to explore the feasibility of patient-led self administration of
flecainide. Part C also includes an exploratory sub-study to assess the feasibility of
implementing a portable cardiac ultrasound (HHE) at screening in an emergent setting.
Phase:
Phase 2
Details
Lead Sponsor:
InCarda Therapeutics Australia Pty Ltd. InCarda Therapeutics, Inc.