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Paroxysmal Atrial FibrillationPhase 4OATNCT01959425

Oral Anticoagulation Therapy Pilot Study

A Phase 4 study testing Off OAT Group (Test) in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Paroxysmal Atrial Fibrillation
What is being tested?
Off OAT Group (Test)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
17 Apr 2013to 7 Oct 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Successful cardiac ablation for AF
  • Documented freedom from AF recurrence (symptomatic or asymptomatic arrhythmic recurrences lasting longer than 30 seconds) 3 months after successful cardiac ablation (AF recurrence during 3-month blanking period is excluded).
  • Patient must have been on a commercially approved anticoagulation therapy for at least two (2) months prior to randomization in the OAT Study.
  • CHADS2 score ≥ 2 or CHA2DS2-VASc score (≥3)
  • Left ventricular ejection fraction > 25%
  • LA size < 65
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  • High risk for thromboembolic events (i.e., CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3) and require OAT before undergoing cardiac ablation
  • Able and willing to comply with all pre- and follow-up testing and requirements
  • Signed informed consent form
  • Age 18 years or older

Who cannot join

  • OAT required for reasons not related to AF (i.e., prosthetic valve, PV stenosis, previous pulmonary embolism, presence of spontaneous echo contrast [SEC] at standard echo performed at 3-months follow-up).
  • Any cardiac surgery within the past 60 days (2 months) or valvular cardiac surgical procedure at any time (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
  • Previous myocardial infarction (MI) or a percutaneous coronary intervention PCI within the past 3 months
  • Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
  • Documented left atrial thrombus
  • Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or COPD) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
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  • Significant medical problem that in the opinion of the investigator would preclude enrollment in this study
  • Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
  • Acute illness or active systemic infection or sepsis
  • Unstable angina
  • Contraindication to anticoagulation (i.e., heparin, warfarin or another commercially available anticoagulation medication)
  • History of blood clotting or bleeding abnormalities
  • Life expectancy less than 360 days (12 months)
  • Uncontrolled Heart Failure or NYHA Class III or IV heart failure
  • Enrollment in a clinical study evaluating another device or drug, within the past 6 months
  • Unable or unwilling to comply with protocol requirements

About this study

Official title: Safety of Oral Anticoagulation Therapy Withdrawal After Successful Cardiac Ablation in Patients With Atrial Fibrillation and Associated High Risk Factors for Embolic Events (OAT Pilot Study)

The objective of this study is to determine the safety of discontinuing oral anticoagulation therapy in high risk patients who have had a successful cardiac ablation and remain AF recurrence free for 3 months post ablation.

Read the detailed description

Patients undergoing successful cardiac ablation for atrial fibrillation who remain AF recurrence-free 3 months after successful ablation and continue to meet the inclusion/exclusion criteria will be screened for enrollment in the trial. After fulfilling all of the inclusion/exclusion criteria, patients who consent to participate in the study and remain AF recurrence-free will be randomized to one of two study arms: (1) OAT Withdrawal (Test) Group or (2) OAT (Control) Group and participate in the Evaluation Period (12 months).

Being tested
Off OAT Group (Test), On OAT Group (Control)
Keywords
Anticoagulation, Oral, Paroxysmal atrial fibrillation, Patients post successful cardiac ablation, Symptomatic high-burden paroxysmal AF, 3 months post procedure, Remain free from AF recurrence
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Off OAT Group (Test)Other

    Discontinuation of OAT Therapy

  • On OAT Group (Control)Other

    Continuation of OAT Therapy

Study groups in NCT01959425
Study groupRoleWhat they receive
Off OAT Group (Test)ExperimentalDiscontinuation of OAT Therapy
Receives: Other: Off OAT Group (Test)
On OAT Group (Control)OtherContinuation of OAT Therapy
Receives: Other: On OAT Group (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Occurrence of Any Major Thromboembolic Event

    Composite endpoint represented by the occurrence of any major thromboembolic event (stroke [i.e., ischemic, hemorrhagic or cryptogenic] that is an acute onset of a focal neurologic deficit of presumed vascular origin lasting for ≥24 hours or resulting in death) or major hemorrhagic complication (major bleeding) during the 12-month Evaluation Period.

    Measured: 12 months

Secondary outcomes (7)

  1. Percentage of Participants With Minor Bleeds

    Any clinical bleed that does not meet criteria for a major hemorrhagic event during the 12-month Evaluation Period.

    Measured: 12 months

  2. Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event

    Hospitalization due to any thromboembolic or major hemorrhagic event during the 12-month Evaluation Period.

    Measured: 12 months

  3. Percentage of Expired Participants

    All cause mortality during the 12-month Evaluation Period.

    Measured: 12 months

  4. Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS)

    The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability.

    Measured: Baseline, 3 months, 12 months

  5. Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS)

    The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability.

    Measured: Baseline, 3 months, 12 months

  6. Percentage of Participants With Atrial Fibrillation Recurrence

    Recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects with recurrence of atrial fibrillation were immediately exited from the study.

    Measured: 12 months

  7. Percentage of Participants With Repeat Ablation

    Repeat ablations performed due to recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects that required a repeat ablation were immediately exited from the study.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2013 (estimated)
  2. Study start17 Apr 2013
  3. Primary completion7 Oct 2019
  4. Study completion7 Oct 2019

Resources

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 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01959425
Sponsor's protocol ID
OAT-149
Acronym
OAT
Status last verified
Jan 2025
First submitted
8 Oct 2013
Last updated
4 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Off OAT Group (Test) in people with Paroxysmal Atrial Fibrillation, run by Biosense Webster, Inc..

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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Occurrence of Any Major Thromboembolic Event (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959425.

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 4 Feb 2025.

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