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Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation

Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01924065
Acronym
AFTER-CV
Enrollment
112
Registered
2013-08-16
Start date
2013-08-31
Completion date
2024-10-29
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Cardioversion, Cerebrovascular Stroke

Keywords

Atrial fibrillation, conversion, stroke

Brief summary

Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 3 weeks with an international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use warfarin will be given an approved new oral anticoagulant agent instead of warfarin for 3 weeks. If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be performed. Other patients in the both groups will undergo electrical cardioversion. After the procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic events detected by diffusion MRI will be recorded. Any bleeding events will also be recorded.

Interventions

PROCEDURECardioversion

Electrical cardioversion

DRUGOral Anticoagulant

warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage

Sponsors

Suleyman Demirel University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients with the age of more than 18 years who are planned to undergo electrical or medical cardioversion

Exclusion criteria

* Urgent cardioversion * Patients who have implanted pace-makers or other metal devices * Claustrophobia * Hematological disorders disabling patients to receive anticoagulant agents * Atrial fibrillation secondary to temporary causes. * Serious rheumatic heart valve disease * Hyperthyroidism * History of malignancy * Left atrium diameter \> 55 mm * Ejection fraction \< 0.25

Design outcomes

Primary

MeasureTime frameDescription
Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli2 yearsClinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion
Efficacy Clinical End-point2 yearsAny Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli
Ischemic Stroke/Transient Ischemic Attack2 years—
Acute Ischemia in MRI1 weekDevelopment of acute silent cerebral ischemia detected by MRI
Mortality2 years—
Hemorrhagic Stroke2 years—
Gastrointestinal Bleeding2 years—

Countries

Turkey (Türkiye)

Participant flow

Participants by arm

ArmCount
Transesophageal Echocardiography Group
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion Cardioversion: Electrical cardioversion
56
Oral Anticoagulant Group
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion. Cardioversion: Electrical cardioversion Oral Anticoagulant: warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
56
Total112

Baseline characteristics

CharacteristicTransesophageal Echocardiography GroupOral Anticoagulant GroupTotal
Acetylsalicylic acid17 Participants15 Participants32 Participants
Age, Continuous61 years
STANDARD_DEVIATION 10.5
60 years
STANDARD_DEVIATION 12.1
60.5 years
STANDARD_DEVIATION 11.3
Amiodarone0 Participants1 Participants1 Participants
Angiotensin converting enzyme inhibitor, Angiotensin receptor blocker20 Participants20 Participants40 Participants
Beta blocker19 Participants33 Participants52 Participants
Calcium channel blocker11 Participants9 Participants20 Participants
Clopidogrel4 Participants3 Participants7 Participants
Congestive heart failure, Hypertension, Age 2, Diabetes, Stroke 2, Vascular, Sex Category Score1.44 units on a scale
STANDARD_DEVIATION 1.11
1.62 units on a scale
STANDARD_DEVIATION 1.05
1.53 units on a scale
STANDARD_DEVIATION 1.08
Coronary artery disease10 Participants10 Participants20 Participants
Diabetes mellitus17 Participants12 Participants29 Participants
Duration of atrial fibrillation3.5 day4 day4 day
Ejection fraction61.3 percent
STANDARD_DEVIATION 6.2
60 percent
STANDARD_DEVIATION 6
60.5 percent
STANDARD_DEVIATION 6.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
56 Participants56 Participants112 Participants
Heart rate104.5 Beats per minute
STANDARD_DEVIATION 23.9
98.3 Beats per minute
STANDARD_DEVIATION 23
101.5 Beats per minute
STANDARD_DEVIATION 23.6
Hypertension27 Participants27 Participants54 Participants
Hypertension,Abnormal liver/renal function, Stroke, Bleeding, LabileINR, Elderly, Drug/alcohol Score0.41 units on a scale
STANDARD_DEVIATION 0.59
0.39 units on a scale
STANDARD_DEVIATION 0.62
0.4 units on a scale
STANDARD_DEVIATION 0.6
Left atrial diameter41 mm
STANDARD_DEVIATION 3.7
42.1 mm
STANDARD_DEVIATION 3.4
41.6 mm
STANDARD_DEVIATION 3.6
Propafenone3 Participants3 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
56 Participants56 Participants112 Participants
Region of Enrollment
Turkey
56 participants56 participants112 participants
Sex: Female, Male
Female
23 Participants23 Participants46 Participants
Sex: Female, Male
Male
33 Participants33 Participants66 Participants
Spironolactone2 Participants5 Participants7 Participants
Type of atrial fibrillation
Paroxysmal
37 Participants36 Participants73 Participants
Type of atrial fibrillation
Persistent
19 Participants20 Participants39 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 562 / 56
other
Total, other adverse events
0 / 560 / 56
serious
Total, serious adverse events
9 / 5610 / 56

Outcome results

Primary

Acute Ischemia in MRI

Development of acute silent cerebral ischemia detected by MRI

Time frame: 1 week

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transesophageal Echocardiography GroupAcute Ischemia in MRI2 Participants
Oral Anticoagulant GroupAcute Ischemia in MRI4 Participants
Primary

Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli

Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transesophageal Echocardiography GroupCombined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli9 Participants
Oral Anticoagulant GroupCombined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli11 Participants
Primary

Efficacy Clinical End-point

Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transesophageal Echocardiography GroupEfficacy Clinical End-point7 Participants
Oral Anticoagulant GroupEfficacy Clinical End-point9 Participants
Primary

Gastrointestinal Bleeding

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transesophageal Echocardiography GroupGastrointestinal Bleeding3 Participants
Oral Anticoagulant GroupGastrointestinal Bleeding2 Participants
Primary

Hemorrhagic Stroke

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transesophageal Echocardiography GroupHemorrhagic Stroke1 Participants
Oral Anticoagulant GroupHemorrhagic Stroke2 Participants
Primary

Ischemic Stroke/Transient Ischemic Attack

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transesophageal Echocardiography GroupIschemic Stroke/Transient Ischemic Attack7 Participants
Oral Anticoagulant GroupIschemic Stroke/Transient Ischemic Attack4 Participants
Primary

Mortality

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Transesophageal Echocardiography GroupMortality3 Participants
Oral Anticoagulant GroupMortality2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026