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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04199702
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Same day discharge
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Same day discharge

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 74 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Moussa C Mansour, PI, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT04199702
Other Study ID Numbers:
  • 2019P003413
First Posted:
Dec 16, 2019
Last Update Posted:
Nov 22, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Nov 22, 2021