Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Other: Same day discharge

• Registration Number: NCT04199702
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Study Start: 2023-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Same day discharge	Same day discharge	-

Primary Outcome Measures

Name	Time	Method
The rate of successful same day discharge after AF ablation procedure	Day of the 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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States