Oral Anticoagulation Therapy Pilot Study (OAT)

January 31, 2025 updated by: Biosense Webster, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Pessac
      • Bordeaux, Pessac, France, 33604
        • Le Centre Hospitalier de Bordeaux
  • Germany
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
  • Italy
    • Venezia
      • Mestre, Venezia, Italy, 30174
        • Ospedale dell'Angelo
  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospitals
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Successful cardiac ablation for AF
  2. 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).
  3. Patient must have been on a commercially approved anticoagulation therapy for at least two (2) months prior to randomization in the OAT Study.
  4. CHADS2 score ≥ 2 or CHA2DS2-VASc score (≥3)
  5. Left ventricular ejection fraction > 25%
  6. LA size < 65
  7. High risk for thromboembolic events (i.e., CHADS2 score ≥ 2 or CHA2DS2-VASc score ≥ 3) and require OAT before undergoing cardiac ablation
  8. Able and willing to comply with all pre- and follow-up testing and requirements
  9. Signed informed consent form
  10. Age 18 years or older

Exclusion Criteria:

  1. 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).
  2. 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)
  3. Previous myocardial infarction (MI) or a percutaneous coronary intervention PCI within the past 3 months
  4. Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
  5. Documented left atrial thrombus
  6. 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
  7. Significant medical problem that in the opinion of the investigator would preclude enrollment in this study
  8. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
  9. Acute illness or active systemic infection or sepsis
  10. Unstable angina
  11. Contraindication to anticoagulation (i.e., heparin, warfarin or another commercially available anticoagulation medication)
  12. History of blood clotting or bleeding abnormalities
  13. Life expectancy less than 360 days (12 months)
  14. Uncontrolled Heart Failure or NYHA Class III or IV heart failure
  15. Enrollment in a clinical study evaluating another device or drug, within the past 6 months
  16. Unable or unwilling to comply with protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Off OAT Group (Test)
Discontinuation of OAT Therapy
Other: Off OAT Group (Test)
Discontinuation of OAT Therapy
Other: On OAT Group (Control)
Continuation of OAT Therapy
Other: On OAT Group (Control)
Continuation of OAT Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Occurrence of Any Major Thromboembolic Event
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Minor Bleeds
Time Frame: 12 months
Any clinical bleed that does not meet criteria for a major hemorrhagic event during the 12-month Evaluation Period.
12 months
Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event
Time Frame: 12 months
Hospitalization due to any thromboembolic or major hemorrhagic event during the 12-month Evaluation Period.
12 months
Percentage of Expired Participants
Time Frame: 12 months
All cause mortality during the 12-month Evaluation Period.
12 months
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS)
Time Frame: Baseline, 3 months, 12 months
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.
Baseline, 3 months, 12 months
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS)
Time Frame: Baseline, 3 months, 12 months
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.
Baseline, 3 months, 12 months
Percentage of Participants With Atrial Fibrillation Recurrence
Time Frame: 12 months
Recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects with recurrence of atrial fibrillation were immediately exited from the study.
12 months
Percentage of Participants With Repeat Ablation
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosense Webster, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio Raviele, MD, Dell'Angelo Hospital
  • Principal Investigator: Michael Riley, MD, University of Pennsylvania
  • Principal Investigator: Karl Heinz Kuck, MD, Hanseatisches Herzzentrum, Asklepios Klinik
  • Principal Investigator: Michel Haissaguerre, MD, Hospital Cardiologigue du Haut-Leveque
  • Principal Investigator: Pierre Jais, MD, Hospital Cardiologigue du Haut-Leveque
  • Principal Investigator: Sakis Themistoclakis, MD, Dell'Angelo Hospital
  • Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Research Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 7, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OAT-149

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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