Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

Atrial Fibrillation Clinical Trial

— PROTOCOLENERGY  

Official title:

Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148923
• Other study ID #: IGS202009
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2023
• Source: Nemocnice AGEL Trinec-Podlesi a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Direct current cardioversion (DCCV) is a widespread method to restore sinus rhythm in patients with atrial fibrillation. It is a safe and effective method of treating atrial fibrillation. In this study, the investigators want to compare two algorithms. The rational one, with lower initial energy and the second one with the maximum possible shock energy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients must have atrial fibrillation or atrial tachycardia.

2. Patients must be on therapeutic anticoagulation at least three weeks prior to DCCV or undergo esophageal echocardiography to rule out intracardiac thrombus.

3. Patients come on an empty stomach.

4. Patients must be over 18 years of age.

5. Patients must provide verbal and written informed consent to participate in the study.

Exclusion Criteria:

1. Omitting oral anticoagulant treatment in the last three weeks.

2. Unclear time of onset of palpitations in acute patients without anticoagulation therapy.

3. A different type of arrhythmia than atrial fibrillation or atrial tachycardia.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Direct current cardioversion (DCCV)
DCCV is a safe and effective method of treating atrial fibrillation.

Locations

Country	Name	City	State
Czechia	Nemocnice AGEL Trinec-Podlesi	Trinec	Ceská Republika (Cesko)

Sponsors (1)

Lead Sponsor	Collaborator
Nemocnice AGEL Trinec-Podlesi a.s.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rhythm after DCCV	sinus rhythm	one minute after DCCV
Primary	Incidence of Neurological Adverse Events	neurological complications	two hours after DCCV
Secondary	Incidence of skin changes	none, skin redness, skin burns	two hours after DCCV
Secondary	Chest pain	0-10 scale of pain severity	one day after DCCV