Oral Anticoagulation Therapy Pilot Study (OAT)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Off OAT Group (Test)
On OAT Group (Control)
Sponsored by
About this trial
This is an interventional other trial for Paroxysmal Atrial Fibrillation focused on measuring Anticoagulation, Oral, Paroxysmal atrial fibrillation, Patients post successful cardiac ablation, Symptomatic high-burden paroxysmal AF, 3 months post procedure, Remain free from AF recurrence
Eligibility Criteria
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
Sites / Locations
- University of Kansas Hospitals
- MetroHealth Medical Center
- University of Pennsylvania
- Texas Cardiac Arrhythmia Research Foundation
- Le Centre Hospitalier de Bordeaux
- Asklepios Klinik St. Georg
- Ospedale dell'Angelo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Off OAT Group (Test)
On OAT Group (Control)
Arm Description
Discontinuation of OAT Therapy
Continuation of OAT Therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Percentage of Expired Participants
All cause mortality during the 12-month Evaluation Period.
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.
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.
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.
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.
Full Information
NCT ID
NCT01959425
First Posted
October 8, 2013
Last Updated
November 20, 2020
Sponsor
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01959425
Brief Title
Oral Anticoagulation Therapy Pilot Study
Acronym
OAT
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)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Study Start Date
April 17, 2013 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 7, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
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
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Off OAT Group (Test)
Arm Type
Experimental
Arm Description
Discontinuation of OAT Therapy
Arm Title
On OAT Group (Control)
Arm Type
Other
Arm Description
Continuation of OAT Therapy
Intervention Type
Other
Intervention Name(s)
Off OAT Group (Test)
Intervention Description
Discontinuation of OAT Therapy
Intervention Type
Other
Intervention Name(s)
On OAT Group (Control)
Intervention Description
Continuation of OAT Therapy
Primary Outcome Measure Information:
Title
Number of Participants With Occurrence of Any Major Thromboembolic Event
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of Participants With Minor Bleeds
Description
Any clinical bleed that does not meet criteria for a major hemorrhagic event during the 12-month Evaluation Period.
Time Frame
12 months
Title
Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event
Description
Hospitalization due to any thromboembolic or major hemorrhagic event during the 12-month Evaluation Period.
Time Frame
12 months
Title
Percentage of Expired Participants
Description
All cause mortality during the 12-month Evaluation Period.
Time Frame
12 months
Title
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS)
Description
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.
Time Frame
Baseline, 3 months, 12 months
Title
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS)
Description
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.
Time Frame
Baseline, 3 months, 12 months
Title
Percentage of Participants With Atrial Fibrillation Recurrence
Description
Recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects with recurrence of atrial fibrillation were immediately exited from the study.
Time Frame
12 months
Title
Percentage of Participants With Repeat Ablation
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Raviele, MD
Organizational Affiliation
Dell'Angelo Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Riley, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karl Heinz Kuck, MD
Organizational Affiliation
Hanseatisches Herzzentrum, Asklepios Klinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Haissaguerre, MD
Organizational Affiliation
Hospital Cardiologigue du Haut-Leveque
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Jais, MD
Organizational Affiliation
Hospital Cardiologigue du Haut-Leveque
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sakis Themistoclakis, MD
Organizational Affiliation
Dell'Angelo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Hospitals
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Le Centre Hospitalier de Bordeaux
City
Bordeaux
State/Province
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Ospedale dell'Angelo
City
Mestre
State/Province
Venezia
ZIP/Postal Code
30174
Country
Italy
12. IPD Sharing Statement
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Oral Anticoagulation Therapy Pilot Study
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