Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation (FAST-AF)

Mass General Brigham

Status: Withdrawn

Conditions: Atrial Fibrillation

Treatments: Other: Same day discharge

Study type: Interventional

Funder types: Other

Identifiers

NCT04199702

2019P003413

Details and patient eligibility

About

Catheter ablation with pulmonary vein (PV) isolation is a commonly performed strategy employed for the treatment of atrial fibrillation. The conventional approach for post-procedure care has been for the patient to stay overnight and be discharged the next day. However, the overall incidence of procedure related complications of catheter ablation for atrial fibrillation in high volume centers is low. New technologies have been introduced and improve the safety of the ablation procedure. Discharging patients the same day after ablation is a practice that's currently followed by many centers in the United States and abroad. The investigators' hypothesis is that the currently available advanced technologies allow for the same-day safe discharge of patients after catheter ablation. The investigators propose a prospective single-arm study to evaluate the feasibility and safety of the same-day discharge after AF ablation at MGH. The protocol of same-day discharge will include the use of a commercially available venous closure device, early ambulation, bed-side echocardiogram, and follow-up phone calls at day 1 and 3 post-procedure.

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 - Age < 75 yr
• Documentation of atrial fibrillation (AF) or atypical atrial flutter
• All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements

Exclusion criteria

• Heart failure with reduced ejection fraction less than 40%
• Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
• INR > 4.0 at the time of the procedure
• Mental impairment precluding verbal consent or completing follow up
• Patients with any other significant uncontrolled or unstable medical condition
• Women who are known to be pregnant or have had a positive β-HCG test within 7 days prior to procedure
• Presence of left atrial thrombus
• Patients with prior prostate hypertrophy or bladder surgery
• BMI > 40 or BMI <20
• Patients with h/o symptomatic heart failure
• Patients with severe aortic stenosis (AS) or severe mitral regurgitation (MR)
• Patients who require femoral arterial line for blood pressure monitoring

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Same day discharge

Other group

Treatment:

Other: Same day discharge