Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation (NCT04199702) | Clinical Trial Compass
WithdrawnNot Applicable
Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
Stopped: Study did not enroll any patients due to lack of resources.
United States0Started 2023-02
Plain-language 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.
Who can participate
Age range
19 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The rate of successful same day discharge after AF ablation procedure