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Optical Tissue Identification for Myocardial Architecture

Study acronym: OPTIMA
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 15, 2023 (before its estimated September 2023 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Mar 2023 to Sep 2023v7
  2. Primary completion date: Mar 8, 2022 to Mar 2023
    • Study completion date: Nov 2022 to Mar 2023
    v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Nov 2022 to Mar 8, 2022
    • Site details revised
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Start date changed from estimate of Nov 15, 2019 to Dec 20, 2019v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Aug 2019 to Nov 15, 2019
    • Primary and study completion dates: Aug 2022 to Nov 2022
    • Site details revised
    • Eligibility criteria expanded, about 3 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this study is to test the hypothesis that fiberoptic confocal microscopy (FCM) imaging during repair of common congenital heart defects is a useful adjunct for avoidance of conduction abnormalities.
Trial Details
NCT Number NCT04017975
Lead Sponsor Aditya Kaza
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Ventricular Septal Defect, Complete Atrioventricular Canal, Tetralogy of Fallot With Pulmonary Stenosis
Related terms Complete atrioventricular septal defect, Heart Septal Defects, Ventricular
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov