Cardiac Ablation Clinical Trials

Clinical trials related to Cardiac Ablation Procedure

Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices. Early rhythm therapy includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management without the above atrial fibrillation rhythm control treatment. Researchers will compare early rhythm control groups to general control groups to see if early rhythm therapy works to reduce the atrial fibrillation burden by 50% or more, or decrease the incidence of clinical AF documentation. Participants will: * Randomly allocated to two groups at a 1:1 ratio. * Receive the treatment according to their assigned group. * Visit the clinic once every three months for checkups and tests.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Among patients with Cardiac implantable electronic device (CIED), subjects with atrial high rate episodes found Cardiac implantable electronic devices: implantable loop recorder, pacemaker, implantable cardioverter defibrillator(ICD), cardiac resynchronized therapy(CRT)

• Patients aged 19 or older who have agreed to the study (if voluntary consent is deemed difficult, consent from legal representatives is obtained together)

• If the accumulated period of the atrial high rate episode during the three-month observation period is more than 21 hours

• Patients whose atrial fibrillation has not been confirmed by electrocardiogram or holter monitoring within the past year from the time atrial high rate episode was detected

⁃ However, enrollment is possible even if it includes one of the following two cases ⓐ Patients diagnosed and recorded as atrial fibrillation on medical records but not confirmed by electrocardiogram or holter monitoring

⁃ ⓑ If there is a record of atrial fibrillation, but Paroxysmal AF less than 30 seconds

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Ju Youn Kim, Clinical assistant professor, MD, Ph.D
kzzoo921@gmail.com
82-2-3410-3419
Time Frame
Start Date: 2024-01-02
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 520
Treatments
Experimental: early rhythm control group
Early rhythm control group receives atrial fibrillation rhythm control treatment based on guidelines. This includes antiarrhythmic treatment, cardioversion, and catheter ablation.~Antiarrhythmic drugs include flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on, and the doctor chooses the drug in consideration of structural heart disease, coronary artery disease, abnormal left ventricular hypertrophy, and heart failure.(Refer to the Korean Heart rhythm Society atrial Fibrillation Treatment Guidelines) Catheter ablation is a procedure that uses high-frequency energy to block the site of tachycardia in the heart. Cardioversion is a procedure that converts the electrical activity of the heart to sinus rhythm by directly giving electric shock on the surface of the heart. Catheter ablation or cardioversion is a treatment method performed only when clinical atrial fibrillation is confirmed.
Active_comparator: general control group
The general control group receives general management without the above atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription.
Related Therapeutic Areas
Sponsors
Collaborators: The Catholic University of Korea, Asan Medical Center, Sinchon Severance Hospital, Yonsei University College of Medicine, Korea University Guro Hospital, Korea University Anam Hospital, Keimyung University Dongsan Medical Center, Inje University Ilsan Paik Hospital, Wonju Severance Christian Hospital
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov