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Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation

Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04199702
Acronym
FAST-AF
Enrollment
0
Registered
2019-12-16
Start date
2023-02-28
Completion date
2024-12-31
Last updated
2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

Patients will be discharged the same day they undergo catheter ablation of atrial fibrillation.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The rate of successful same day discharge after AF ablation procedureDay of the AF ablation procedureThe rate of successful same day discharge after AF ablation procedure in more than 80% of cases that undergo the AF ablation procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026