Prevention of Postop Atrial Fibrillation Through Intraoperative Inducibility of Atrial Fibrillation and Amiodarone Treatment

Conditions

• Postoperative Atrial Fibrillation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Amiodarone Injection — DRUG
  Patients stratified into the amiodarone study group were administered amiodarone until day of discharge. Amiodarone administration began intraoperatively with the administration of a 150 mg IV amiodarone loading bolus prior to separation from coronary pulmonary bypass, followed by 1 mg/min IV amiodarone for six hours (360 mg), then 0.5 mg/min IV amiodarone for 18 hours (540 mg), then transitioned to 400 mg oral amiodarone twice a day until discharge. In total, patients in the amiodarone treatment group received 1,050mg of IV amiodarone plus 800mg/day of oral amiodarone thereafter until discharge.
• Intraoperative Rapid Atrial Pacing — DEVICE
  Intraoperative rapid atrial pacing for 30 seconds after cannulation and prior to initiation of cardiopulmonary bypass by having the surgeon attach insulated forceps to the superior right atrial free wall and connected to a temporary pacemaker to burst pace at a rate of 800 bpm for 30 seconds (pulse width 1.0 ms, output: 20 mA) Patients are monitored for successful atrial fibrillation induction defined as 30 seconds of sustained atrial fibrillation on ECG.

Study Details

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

Key Dates

Start date

Mar 1, 2017

Status verified

Feb 2026

Primary completion

Dec 31, 2030

Completion

Dec 31, 2050

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Inducible Atrial Fibrillation
  Treatment with Amiodarone
• Other: Inducible Atrial Fibrillation - Standard Care
  No initial Amiodarone Treatment unless POAF seen on post operative care unit.
• Other: Non-Inducible Atrial Fibrillation
  Amiodarone treatment if POAF seen on post-operative care unit

Primary Outcome Measure

Decreasing the incidence of Post-Operative Atrial Fibrillation for Cardiac Surgery Patients [ Time Frame: 30 days ]

Central Contacts

• Anson Lee, MD
  650-724-7500
  [email protected]

Locations (1)

Find similar trials in Stanford, CA

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