Cardiac Disease
Conditions
Brief summary
To determine the efficacy of cardioversion and amiodarone for cardiac patients who develop postoperative atrial fibrillation
Detailed description
New-onset atrial fibrillation (AF) after cardiac surgery is a well-recognized phenomenon with significant outcome implications. Incidence after coronary artery bypass grafting (CABG) is estimated at 26-33%, while those undergoing valvular surgery bear a greater burden at 33-49%. Clinical and socioeconomic complications resulting from postoperative atrial fibrillation include an increased risk of death (10%), congestive heart failure (4%), prolonged hospital stays, and increased rate of discharge to care facilities over those who remain in sinus rhythm, (7%). Although a body of evidence exists for electrical or pharmacological cardioversion to sinus rhythm postoperatively, there is a marked paucity in the literature regarding efficacy and outcomes combining the two. More specifically, we seek to evaluate the efficacy of DC cardioversion when combined with amiodarone. Improved outcomes with multimodal cardioversion may decrease the postoperative clinical burden of atrial fibrillation on cardiac surgery patients.
Interventions
DRUGAmiodarone
Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
PROCEDURECardioversion
Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who underwent CABG and/or cardiac valve surgery involving cardiopulmonary bypass and develop postoperative atrial fibrillation within 7 days after surgery
Exclusion criteria
* Subjects who had any form of atrial fibrillation prior to surgery * Subjects who were on antiarrhythmic medications preoperatively, including but not limited to procainamide and amiodarone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Rhythm | Participants will be followed for the duration of their hospital stay post surgery with an expected average of 7 to 10 days and again at surgical follow up appointment up to 6 weeks. | Measuring change from baseline cardiac rhythm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amiodarone With Cardioversion If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.
Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Amiodarone With Cardioversion |
|---|---|
| Age, Continuous | 87 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Subject Rhythm
Measuring change from baseline cardiac rhythm.
Time frame: Participants will be followed for the duration of their hospital stay post surgery with an expected average of 7 to 10 days and again at surgical follow up appointment up to 6 weeks.
Population: Converted to normal sinus rhythm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Amiodarone With Cardioversion | Subject Rhythm | 1 Participants |