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Oral Anticoagulation Therapy Pilot Study (OAT)

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ClinicalTrials.gov Identifier: NCT01959425
Recruitment Status : Recruiting
First Posted : October 10, 2013
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Other: Off OAT Group (Test) Other: On OAT Group (Control) Phase 4

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)
Actual Study Start Date : August 1, 2013
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Off OAT Group (Test)
Discontinuation of OAT Therapy
Other: Off OAT Group (Test)
Discontinuation of OAT Therapy

On OAT Group (Control)
Continuation of OAT Therapy
Other: On OAT Group (Control)
Continuation of OAT Therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: 12 months ]
    Minor bleeds

  2. Hospitalization [ Time Frame: 12 months ]
    Hospitalization with any thromboembolic or major hemorrhagic event

  3. Mortality [ Time Frame: 12 months ]
    All cause mortality

  4. Quality of Life [ Time Frame: 12 months ]
    Quality of Life Questionnaire (SF-36)

  5. Atrial fibrillation recurrence [ Time Frame: 12 months ]
    Recurrence of atrial fibrillation- Subject with recurrence of atrial fibrillation will be immediately exited from the study

  6. Repeat ablation [ Time Frame: 12 months ]
    Repeat ablation for atrial fibrillation- Subjects requiring a repeat ablation for AFib will be immediately exited from the study



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959425


Contacts
Contact: Chris Hendricks (909) 839-8447
Contact: Janel Noche (909) 839-7720

Locations
United States, Kansas
University of Kansas Hospitals Recruiting
Kansas City, Kansas, United States, 66160
Contact: Molly Gunter    913-588-5969    mgunter@kumc.edu   
Principal Investigator: Dhanunjaya Lakkireddy, MD         
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Pete Leo    216-778-2714    pleo@metrohealth.org   
Principal Investigator: Ohad Ziv, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Rosanne Clayton    215-615-5226    Rosanne.Clayton@uphs.upenn.edu   
Principal Investigator: Michael Riley, MD         
United States, Texas
Texas Cardiac Arrhythmia Research Foundation Recruiting
Austin, Texas, United States, 78705
Contact: Deborah Cardinal, RN    512-458-9410    dscardinal@gmail.com   
Principal Investigator: Andrea Natale, MD         
France
Le Centre Hospitalier de Bordeaux Recruiting
Bordeaux, Pessac, France, 33604
Contact: Isabelle Brunello    +33 5 57 62 30 91    isabelle.brunello@chu-bordeaux.fr   
Principal Investigator: Pierre Jais, MD         
Germany
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Sakine Struck    +49 40 1818 85 3303    s.struck@asklepios.com   
Principal Investigator: Karl-Heinz Kuck, MD         
Italy
Ospedale dell'Angelo Recruiting
Mestre, Venezia, Italy, 30174
Contact: Antonio Rossillo, MD       antoniorossillo@yahoo.com   
Principal Investigator: Sakis Themistoclakis, MD         
Sponsors and Collaborators
Biosense Webster, Inc.
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
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

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01959425     History of Changes
Other Study ID Numbers: OAT-149
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biosense Webster, Inc.:
Anticoagulation
Oral
Paroxysmal atrial fibrillation
Patients post successful cardiac ablation
Symptomatic high-burden paroxysmal AF
3 months post procedure
Remain free from AF recurrence

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes