PROTOCOLENERGY: Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy

• Sponsor: Nemocnice AGEL Trinec-Podlesi a.s. (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05148923
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Direct current cardioversion (DCCV)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Two DCCV Algorithms - Rational Versus Maximum Fixed Energy
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Rational energy algorithm 150 J, 360 J, 360 J biphasic DCCV	Procedure: Direct current cardioversion (DCCV); DCCV is a safe and effective method of treating atrial fibrillation.
Active Comparator: Maximum fixed energy algorithm 3x 360 J biphasic DCCV	Procedure: Direct current cardioversion (DCCV); DCCV is a safe and effective method of treating atrial fibrillation.

Outcome Measures

Primary Outcome Measures

1. Heart rhythm after DCCV [one minute after DCCV]

   sinus rhythm

2. Incidence of Neurological Adverse Events [two hours after DCCV]

   neurological complications

Secondary Outcome Measures

1. Incidence of skin changes [two hours after DCCV]

   none, skin redness, skin burns

2. Chest pain [one day after DCCV]

   0-10 scale of pain severity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nemocnice AGEL Trinec-Podlesi	Trinec	Česká Republika (Česko)	Czechia	73961

Sponsors and Collaborators

• Nemocnice AGEL Trinec-Podlesi a.s.

Investigators

• Principal Investigator: Lucjan Rucki, MD, Nemocnice AGEL Trinec-Podlesi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lucjan Rucki, Principal Investigator, Nemocnice AGEL Trinec-Podlesi a.s.
• ClinicalTrials.gov Identifier: NCT05148923
• Other Study ID Numbers: IGS202009
• First Posted: Dec 8, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lucjan Rucki, Principal Investigator, Nemocnice AGEL Trinec-Podlesi a.s.: DCCV; atrial fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Apr 6, 2022