Acute Atrial Fibrillation and Flutter Treated Electively

NCT ID: NCT04267159

Last Updated: 2024-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-10
• Study Completion Date: 2029-06-30

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional treatment by acute cardioversion

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.

Group Type: ACTIVE_COMPARATOR

Acute cardioversion

Intervention Type: OTHER

Acute restoration of sinus rhythm by medical or electrical cardioversion in the emergency department

Elective treatment by delayed cardioversion

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.

Group Type: EXPERIMENTAL

Delayed cardioversion

Intervention Type: OTHER

Delayed restoration of sinus rhythm by medical or electrical cardioversion in the out-patient clinic

Interventions

Acute cardioversion

Acute restoration of sinus rhythm by medical or electrical cardioversion in the emergency department

Intervention Type: OTHER

Delayed cardioversion

Delayed restoration of sinus rhythm by medical or electrical cardioversion in the out-patient clinic

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University

OTHER

Sponsor Role: lead

Responsible Party

Jussi Hernesniemi

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jussi A Hernesniemi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

TAYS Heart Hospital and Tampere University

Locations

Central Finland Central Hospital

Jyväskylä, Central Finland, Finland

Site Status: RECRUITING

Kanta-Häme Central Hospital

Hämeenlinna, Kanta-Häme, Finland

Site Status: RECRUITING

Päijät-Häme Central Hospital

Lahti, Paijat-Hame Region, Finland

Site Status: NOT_YET_RECRUITING

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Jussi A Hernesniemi, MD, PhD

Role: CONTACT

Phone: 31164254

Email: jussi.hernesniemi@sydansairaala.fi

Tero Penttilä, MD, PhD

Role: CONTACT

Email: tero.penttila@sydansairaala.fi

Facility Contacts

Tuomo Kyrönlahti, MD

Role: primary

Ari Palomäki, MD, PhD

Role: primary

Tuomo Nieminen, MD, PhD

Role: primary

Jussi A Hernesniemi, MD, PhD

Role: primary

Other Identifiers

ETL R19133

Identifier Type: -

Identifier Source: org_study_id