- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01959425
Oral Anticoagulation Therapy Pilot Study (OAT)
November 20, 2020 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
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
80
Phase
- 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
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Pessac
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Bordeaux, Pessac, France, 33604
- Le Centre Hospitalier de Bordeaux
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-
-
-
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Hamburg, Germany, 20099
- Asklepios Klinik St. Georg
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-
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Venezia
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Mestre, Venezia, Italy, 30174
- Ospedale dell'Angelo
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Hospitals
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Ohio
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Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Texas
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Austin, Texas, United States, 78705
- Texas Cardiac Arrhythmia Research Foundation
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-
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
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Off OAT Group (Test)
Discontinuation of OAT Therapy
|
Discontinuation of OAT Therapy
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OTHER: On OAT Group (Control)
Continuation of OAT Therapy
|
Continuation of OAT Therapy
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What is the study measuring?
Primary Outcome Measures
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Minor Bleeds
Time Frame: 12 months
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Any clinical bleed that does not meet criteria for a major hemorrhagic event during the 12-month Evaluation Period.
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12 months
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Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event
Time Frame: 12 months
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Hospitalization due to any thromboembolic or major hemorrhagic event during the 12-month Evaluation Period.
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12 months
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Percentage of Expired Participants
Time Frame: 12 months
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All cause mortality during the 12-month Evaluation Period.
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12 months
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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
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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
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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
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Recurrence of atrial fibrillation during the 12-month Evaluation Period.
Subjects with recurrence of atrial fibrillation were immediately exited from the study.
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12 months
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Percentage of Participants With Repeat Ablation
Time Frame: 12 months
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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.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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
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)
April 17, 2013
Primary Completion (ACTUAL)
October 7, 2019
Study Completion (ACTUAL)
October 7, 2019
Study Registration Dates
First Submitted
October 8, 2013
First Submitted That Met QC Criteria
October 9, 2013
First Posted (ESTIMATE)
October 10, 2013
Study Record Updates
Last Update Posted (ACTUAL)
December 17, 2020
Last Update Submitted That Met QC Criteria
November 20, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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