Atrial FibrillationFAST-AFNCT04199702
Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
A study testing Same day discharge in people with Atrial Fibrillation, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Same day discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
- Being tested
- Same day discharge
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same day dischargeOther
Patients will be discharged the same day they undergo catheter ablation of atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Same day discharge | Other | Not described Receives: Other: Same day discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day of the AF ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study startFeb 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Study did not enroll any patients due to lack of resources.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moussa C Mansour, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199702
- Sponsor's protocol ID
- 2019P003413
- Acronym
- FAST-AF
- Status last verified
- Feb 2024
- First submitted
- 12 Dec 2019
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Same Day Discharge afTer Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT04199702
- Acronym / sponsor ID
- FAST-AF / 2019P003413
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not enroll any patients due to lack of resources.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Same day discharge | Other | Other: Same day discharge |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same day dischargePatients will be discharged the same day they undergo catheter ablation of atrial fibrillation. | Other | Same day discharge |
Primary outcome
The rate of successful same day discharge after AF ablation procedure
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same day discharge in people with Atrial Fibrillation, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful same day discharge after AF ablation procedure (time frame: Day of the AF ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.