Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation (FAST-AF)
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Same day discharge
Sponsored by
About this trial
This is an interventional supportive care trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Same day discharge
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04199702
First Posted
December 12, 2019
Last Updated
December 8, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04199702
Brief Title
Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
Acronym
FAST-AF
Official Title
Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Same day discharge
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Same day discharge
Intervention Description
Patients will be discharged the same day they undergo catheter ablation of atrial fibrillation.
Primary Outcome Measure Information:
Title
The rate of successful same day discharge after AF ablation procedure
Description
The rate of successful same day discharge after AF ablation procedure in more than 80% of cases that undergo the AF ablation procedure
Time Frame
Day of the AF ablation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Ha
Phone
617-643-1697
Email
gha2@mgh.harvard.edu
12. IPD Sharing Statement
Learn more about this trial
Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
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