Decision Aid for R-AAOCA Pilot Study, NCT07544979
ClinicalTrials.gov Studies
Summary
NIH registered a pilot study (NCT07544979) titled 'Creation of a Decision Aid for Coronary Anomalies' targeting patients with right anomalous aortic origin of a coronary artery (R-AAOCA). The study will develop a shared decision-making (SDM) aid to help patients, families, and clinicians weigh surgical versus observational management given the low but elevated risk of sudden cardiac death. The study hypothesis is that decision aid use will improve SDM, comfort in choice, and quality of life. Approximately 3-5 participants are expected to enroll in this pilot.
About this source
GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 734 changes logged to date.
What changed
This registry entry adds a new NIH ClinicalTrials.gov record for a pilot study focused on creating a decision aid for R-AAOCA. The study addresses a gap in available tools for shared decision-making regarding coronary anomaly management, where no existing decision aid is documented for this patient population. Healthcare providers involved in congenital heart disease care and patients facing R-AAOCA management decisions may benefit from monitoring this pilot's outcomes, as successful implementation could inform clinical practice guidelines.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Creation of a Decision Aid for Coronary Anomalies
N/A NCT07544979 Kind: NA Apr 22, 2026
Abstract
The coronary arteries supply blood to the heart muscle. Typically, the left coronary artery comes from the left side of the aorta and the right coronary artery comes from the right side. In some cases the coronary artery comes from the wrong side of the aorta. This is known as anomalous aortic origin of a coronary artery (AAOCA). In AAOCA, the major concern is the risk of sudden cardiac death (SCD). The risk of is significantly higher in left AAOCA (L-AAOCA) compared to right AAOCA (R-AAOCA). With the increased risk in L-AAOCA, surgery is recommended to "normalize" the coronary artery position. R-AAOCA has a low absolute risk of SCD. But the risk is higher than the general population. Patients, families, and clinicians must weigh the risks of surgery with the risks of observation. This leads to stress and anxiety around making the management choice. There is no "right" management choice. Shared decision making (SDM) is a strategy of including patient values, preferences, and risk tolerance in medical choices. SDM is particularly useful in settings where there is no clear correct management choice. Decision aids support SDM. No decision aid exists in R-AAOCA. This proposal will create a decision aid and collect pilot data of its implementation. We hypothesize that the use of an aid in R-AAOCA will improve SDM, comfort in the choice, and quality of life. We will engage patients, families, and clinicians to understand their needs to make management choices. This will inform t...
Conditions: AAOCA
Interventions: Decision aid
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.