Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation

Atrial Fibrillation Clinical Trial

— FAST-AF  

Official title:

Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04199702
• Other study ID #: 2019P003413
• Status: Withdrawn
• Phase: N/A
• Start date: February 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Same day discharge
Patients will be discharged the same day they undergo catheter ablation of atrial fibrillation.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful same day discharge after AF ablation procedure	The rate of successful same day discharge after AF ablation procedure in more than 80% of cases that undergo the AF ablation procedure	Day of the AF ablation procedure