NCT03868150 Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment
| NCT ID | NCT03868150 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Stanford University |
| Condition | Postoperative Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2017-03-01 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2017-03-01 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients undergoing first time cardiac surgery will undergo rapid atrial pacing prior to initiation of cardiopulmonary bypass to screen for AF inducibility. Patients with inducible AF will be randomized to prophylactic amiodarone treatment versus no treatment. Patients who are not inducible to AF will be treated with standard post-operative care. Patients will be monitored post-operatively to explore the value of intraoperative inducibility of AF to predict POAF and to evaluate whether the combination of intraoperative inducibility and precision amiodarone therapy is effective at reducing the incidence of POAF
Eligibility Criteria
Inclusion Criteria: * Patients scheduled for first-time non-emergent open-heart surgery for coronary artery bypass graft (CABG) revascularization, valvular repair or replacement, combined CABG with valve repair or replacement, or valve sparing aortic root repair * Normal sinus rhythm * No documented history of atrial fibrillation Exclusion Criteria: * Prior surgical procedures involving heart surgery and cardiopulmonary bypass * Any prior documented history of atrial fibrillation, atrial flutter or atrial tachycardia lasting longer than 30 seconds * Prior history of Amiodarone treatment for the management of supraventricular tachy-arrhythmias * Patients requiring surgical treatment of atrial arrhythmias such as pulmonary vein isolation or Maze procedure.
Contact & Investigator
Anson Lee, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT03868150 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Postoperative Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03868150 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03868150 currently recruiting?
Yes, NCT03868150 is actively recruiting participants. Contact the research team at ansonlee@stanford.edu for enrollment information.
Where is the NCT03868150 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT03868150 clinical trial?
NCT03868150 is sponsored by Stanford University. The principal investigator is Anson Lee, MD at Stanford University. The trial plans to enroll 600 participants.
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