Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation

NCT04199702 | Withdrawn

• 1 other identifier: 2019P003413
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

  Day of the AF ablation procedure

Study Arms (1)

Same day discharge

OTHER

Other: Same day discharge

Interventions

Same day discharge OTHER

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

Same day discharge

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

US (1)