Oral Anticoagulation Therapy Pilot Study

Paroxysmal Atrial Fibrillation Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01959425
• Other study ID #: OAT-149
• Status: Terminated
• Phase: Phase 4
• Start date: April 17, 2013
• Est. completion date: October 7, 2019

Study information

• Verified date: November 2020
• Source: Biosense Webster, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: October 7, 2019
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Other:
• Off OAT Group (Test)
Discontinuation of OAT Therapy
• On OAT Group (Control)
Continuation of OAT Therapy

Locations

Country	Name	City	State
France	Le Centre Hospitalier de Bordeaux	Bordeaux	Pessac
Germany	Asklepios Klinik St. Georg	Hamburg
Italy	Ospedale dell'Angelo	Mestre	Venezia
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University of Kansas Hospitals	Kansas City	Kansas
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Biosense Webster, Inc.

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	Percentage of Expired Participants	All cause mortality during the 12-month Evaluation Period.	12 months
Secondary	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.	Baseline, 3 months, 12 months
Secondary	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.	Baseline, 3 months, 12 months
Secondary	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.	12 months
Secondary	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.	12 months