Acute Atrial Fibrillation and Flutter Treated Electively (AFFELECT)
Primary Purpose
Atrial Fibrillation, Atrial Flutter
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Acute cardioversion
Delayed cardioversion
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Patients presenting with acute (<48hours) atrial fibrillation or atrial flutter to ER
- Planned acute rhythm control for the arrhythmia by the attending physician in ER
- Good perceived health as assessed by attending physician in ER
- Resting heart rate 110bpm or lower before or after adequate rate control therapy
Exclusion Criteria:
- Haemodynamically stable (mean arterial pressure above 60mmHg)
- Need for acute restoration of sinus rhythm due to some other somatic cause
- No other major complicating acute illness (e.g. decompensated HF or acute MI)
- Anticoagulation not safe
- Mechanical heart valve or mitral stenosis
- The need for prolonged (>24h) hospitalization due to any cause
- Exceptionally high risk for thromboembolic events (e.g. history of thromboembolic stroke regardless of adequate anticoagulation)
- Transesophageal echocardiography contraindicated
Sites / Locations
- Central Finland Central HospitalRecruiting
- Kanta-Häme Central Hospital
- Tampere University HospitalRecruiting
- Päijät-Häme Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional treatment by acute cardioversion
Elective treatment by delayed cardioversion
Arm Description
Participants in the conventional treatment arm will be returned to sinus rhythm in the emergency department within 48 hours of symptom onset unless they convert to sinus rhythm spontaneously.
Participants in the elective treatment arm will be returned to sinus rhythm in an out-patient clinic approximately one week after randomizatio unless they convert to sinus rhythm spontaneously.
Outcomes
Primary Outcome Measures
Sinus Rhythm
Prevalence of sinus rhythm in the treatment arms measured by electrocardiography
Secondary Outcome Measures
Number of cardioversions after emergency department
The number of performed cardioversions (electrical or medical)
Number of cardioversions after out-patient clinic
The number of performed cardioversions (electrical or medical)
Overall number of cardioversions
The number of performed cardioversions (electrical or medical)
Drop-out from delayed cardioversion group
The number of subjects needing unplanned cardioversion before preplanned out-patient clinic visit (four days or earlier after randomization) due to medical reasons or due to subjectively perceived unbearable symptoms (EHRA III or IV).
Rehospitalization due to cardiovascular causes
Rehospitalization due to any cardiovascular cause
Immediate quality of life
Quality of life as assessed by questionnaires depicting quality of life
Quality of life after out-patient clinic
Quality of life as assessed by questionnaires depicting quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04267159
Brief Title
Acute Atrial Fibrillation and Flutter Treated Electively
Acronym
AFFELECT
Official Title
Acute Atrial Fibrillation and Flutter Treated Electively - A Randomized Controlled Clinical Trial on the Safety of Elective Management of Acute Atrial Fibrillation and Flutter
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The AFFELECT -study compares two types of treatment modalities for acute atrial fibrillation or flutter for patients in whom rhythm control is desirable. The main purpose is to observe if these arrhythmias can be safely treated electively (within 5-9 days).
All patients are recruited in the emergency department. Patients must be in good clinical condition so that they can be discharged regardless to which treatment modality is randomly selected to them. Patients randomized to conventional care are treated conventionally which means acute rhythm control is applied by electrical or medical cardioversion in the emergency department (within 48 hours of onset of the arrhythmia). Patients randomized to elective care are discharged immediately after adequate temporary rhythm control is assured.
All patients will visit a cardiologist out-patient clinic at approximately one week after the emergency room visit. Patients randomized to elective treatment and still in atrial fibrillation or in atrial flutter will be restored to sinus rhythm by electrical or medical cardioversion at the out-patient clinic. Cardiovascular status and treatment options are evaluated for all patients.
Anticoagulation is managed according existing guidelines for all patients. Due to possibility of delayed cardioversion in the interventional group (elective care group), all patients receive anticoagulation before the out-patient clinic despite their thromboembolic risk. All patients who have not received adequate anticoagulation for three weeks prior to the delayed cardioversion will undergo a transesophageal cardiac ultrasound to ensure they are not in excess risk for thromboembolic events. Patients randomized to elective treatment have the possibility to opt-out and undergo acute cardioversion if their symptoms are unmanageable during the first week before the out-patient clinical.
All patients are monitored for their symptoms by a standardized quality-of-life questionnaire and for possibly required acute medical interventions during the first week and one month after the out-patient clinic. After one month, all patients undergo an electrocardiography (ECG) to ensure the maintenance of normal rhythm in both treatment groups. After the months follow-up all patients are subsequently monitored for a maximum of five years for need of medical interventions due to atrial fibrillation of atrial flutter. New antiarrhythmics such as flecainide are not prescribed during the first month.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The AFFECT trial is a randomized clinical trial with a non-inferioirity setting studying the applicability of delayed rhythm control in the management of acute paroxysmal or persistent atrial fibrillation or flutter.
Patients are randomized to two treatment protocols in 2:3 ratio. For every two patients randomized to conventional treatment, three patients are randomized to experimental treatment. The randomization ratio is designed to allow for maximally one third of the patients in the experimental treatment group to drop-out without compromising the power of the study.
Overall five hundred patients are required to show non-inferiority with a one-sided alpha value 0.025 and 90% power expecting a maximal drop out rate of 33% (n=100) from the experimental treatment arm.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional treatment by acute cardioversion
Arm Type
Active Comparator
Arm Description
Participants in the conventional treatment arm will be returned to sinus rhythm in the emergency department within 48 hours of symptom onset unless they convert to sinus rhythm spontaneously.
Arm Title
Elective treatment by delayed cardioversion
Arm Type
Experimental
Arm Description
Participants in the elective treatment arm will be returned to sinus rhythm in an out-patient clinic approximately one week after randomizatio unless they convert to sinus rhythm spontaneously.
Intervention Type
Other
Intervention Name(s)
Acute cardioversion
Intervention Description
Acute restoration of sinus rhythm by medical or electrical cardioversion in the emergency department
Intervention Type
Other
Intervention Name(s)
Delayed cardioversion
Intervention Description
Delayed restoration of sinus rhythm by medical or electrical cardioversion in the out-patient clinic
Primary Outcome Measure Information:
Title
Sinus Rhythm
Description
Prevalence of sinus rhythm in the treatment arms measured by electrocardiography
Time Frame
One month after preplanned out-patient clinic visit
Secondary Outcome Measure Information:
Title
Number of cardioversions after emergency department
Description
The number of performed cardioversions (electrical or medical)
Time Frame
First week after randomization and before the preplanned out-patient clinic
Title
Number of cardioversions after out-patient clinic
Description
The number of performed cardioversions (electrical or medical)
Time Frame
One month after out-patient clinic
Title
Overall number of cardioversions
Description
The number of performed cardioversions (electrical or medical)
Time Frame
From randomization to the end of first month follow-up after out-patient clinic visit
Title
Drop-out from delayed cardioversion group
Description
The number of subjects needing unplanned cardioversion before preplanned out-patient clinic visit (four days or earlier after randomization) due to medical reasons or due to subjectively perceived unbearable symptoms (EHRA III or IV).
Time Frame
Four days or earlier after randomization to elective (delayed) treatment group
Title
Rehospitalization due to cardiovascular causes
Description
Rehospitalization due to any cardiovascular cause
Time Frame
One week before and one month after out-patient clinic visit
Title
Immediate quality of life
Description
Quality of life as assessed by questionnaires depicting quality of life
Time Frame
First week after randomization and before the preplanned out-patient clinic
Title
Quality of life after out-patient clinic
Description
Quality of life as assessed by questionnaires depicting quality of life
Time Frame
One month after out-patient clinic
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with acute (<48hours) atrial fibrillation or atrial flutter to ER
Planned acute rhythm control for the arrhythmia by the attending physician in ER
Good perceived health as assessed by attending physician in ER
Resting heart rate 110bpm or lower before or after adequate rate control therapy
Exclusion Criteria:
Haemodynamically stable (mean arterial pressure above 60mmHg)
Need for acute restoration of sinus rhythm due to some other somatic cause
No other major complicating acute illness (e.g. decompensated HF or acute MI)
Anticoagulation not safe
Mechanical heart valve or mitral stenosis
The need for prolonged (>24h) hospitalization due to any cause
Exceptionally high risk for thromboembolic events (e.g. history of thromboembolic stroke regardless of adequate anticoagulation)
Transesophageal echocardiography contraindicated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jussi A Hernesniemi, MD, PhD
Phone
31164254
Ext
+358
Email
jussi.hernesniemi@sydansairaala.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Tero Penttilä, MD, PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jussi A Hernesniemi, MD, PhD
Organizational Affiliation
TAYS Heart Hospital and Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland Central Hospital
City
Jyväskylä
State/Province
Central Finland
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuomo Kyrönlahti, MD
Email
tuomo.kyronlahti@ksshp.fi
Facility Name
Kanta-Häme Central Hospital
City
Hämeenlinna
State/Province
Kanta-Häme
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ari Palomäki, MD, PhD
Facility Name
Tampere University Hospital
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
03220
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jussi A Hernesniemi, MD, PhD
Phone
31164254
Ext
+358
Email
jussi.hernesniemi@sydansairaala.fi
Facility Name
Päijät-Häme Central Hospital
City
Lahti
State/Province
Päijät-Häme
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tuomo Nieminen, MD, PhD
Email
tuomo.nieminen@phshp.fi
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD can be shared only upon reasonable request after full anonymization by the discretion of the study review board.
Learn more about this trial
Acute Atrial Fibrillation and Flutter Treated Electively
We'll reach out to this number within 24 hrs