Oral Anticoagulation Therapy Pilot Study - Clinical Trial for Paroxysmal Atrial Fibrillation | NCT01959425

Back to results

Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Off OAT Group (Test)

On OAT Group (Control)

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

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: