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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03932604
Other study ID # SMC-2019-01-149-03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date May 31, 2023

Study information

Verified date June 2021
Source Samsung Medical Center
Contact Seung-Jung Park, PhD
Phone +82-2-3410-7145
Email orthovics@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This prospective multi-center randomized controlled study aims to compare atrial fibrillation detection and inappropriate therapy according to activation of atrial sensing capability in patients with implantable cardioverter defibrillator.


Description:

Implantable cardioverter defibrillators(ICD) therapy has been shown to reduce sudden cardiac death and improve survival in cardiac arrest survivors as well as in heart failure patients with left ventricular dysfunction. Atrial fibrillation (AF) is commonly found in ICD implantation patients up to 50%. AF is an independent predictor of mortality, inappropriate shock, and embolic events. Therefore, early detection of AF in patients with ICD is essential for improving the quality of life and overall prognosis of the patients. Conventional ICDs consist of a single chamber (SC) ICD with a lead only in the right ventricle (RV) and dual chamber (DC) ICD with each lead in the right atrium (RA) and RV. SC ICD has the advantage of shorter procedure time, lower cost compared to DC ICD. In contrast, DC ICD has the advantage of being able to monitor atrial arrhythmic events, but complication rates were higher and additional cost and longer procedure time are usually required than SC ICD. Sixty percent of ICD implantation patients who have are SC ICD Recently, a unique ICD lead with atrial sensing ring capable of monitoring the atrial electrical signals has been developed [Intica 7 VR-T DX ICD (Biotronik., Germany)]. Therefore, turning off the atrial sensing function makes it functionally the same as SC ICD whereas turning on makes it function similar to DC ICD without additional cost and procedure time. Therefore, Detection of AF could be made earlier with VDD ICD versus conventional SC ICD without atrial sensing capability, providing a better chance to improve the prognosis of ICD patients. However, no study exists which shows whether VDD ICD is better for detecting atrial tachyarrhythmia than conventional SC ICD. Therefore, we designed a multicenter prospective randomized study comparing the AF diagnostic efficacy of VDD ICD (with atrial sensing 'ON') against conventional SC ICD. As the second phase, we also plan to compare inappropriate therapy rate according to atrial sensing status of VDD ICD.


Recruitment information / eligibility

Status Recruiting
Enrollment 640
Est. completion date May 31, 2023
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. age = 19 years 2. indication for ICD implantation according to guidelines 3. atrial fibrillation didn't detect by electrocardiogram or Holter test within the past 1 year from the ICD implantation, and 4. CHA2DS2VASc score =1 point in male or = 2 in female Exclusion Criteria: 1. persistent or permanent atrial fibrillation (AF) 2. atrial fibrillation detected by electrocardiogram or Holter test within the past 1 year from the ICD implantation 3. history of the catheter or surgical ablation of AF or taking antiarrhythmic drug 4. scheduled to undergo heart transplant within 1 year 5. life expectancy < 1 year 6. requiring atrial pacing

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Atrial sensing On mode
Single lead VDD-ICD programmed as atrial sensing On mode.

Locations

Country Name City State
Korea, Republic of Sejong General Hospital Bucheon
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Samsung Changwon Medical Center Changwon
Korea, Republic of Chungbuk National University Hospital Cheongju
Korea, Republic of Kangwon National University Hospital Chuncheon
Korea, Republic of Daegu Catholic University Medical Center Daegu
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Yeongnam University Medical Center Daegu
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of GangNeung Asan Hospital Gangneung
Korea, Republic of National Health Insurance Service Ilsan Hospital Goyang
Korea, Republic of Gachon University, Donginchoen Gil Hospital Incheon
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of Mediplex Sejong Hospital Incheon
Korea, Republic of Kosin University Gospel Hospital Pusan
Korea, Republic of Pusan National University Hospital Pusan
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Hallym University Medical Center-Kangnam Seoul
Korea, Republic of Kangbuk Samsung Medical Center Seoul
Korea, Republic of Koera University Guro Hospital Seoul
Korea, Republic of Kyung Hee University Hospital Seoul
Korea, Republic of Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seoul
Korea, Republic of VHS Medical Center Seoul
Korea, Republic of Ajou University Hospital Suwon
Korea, Republic of The Catholic University of Korea, St. Vincent's Hospital Suwon

Sponsors (2)

Lead Sponsor Collaborator
Samsung Medical Center Biotronik SE & Co. KG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Atrial fibrillation cardiac implantable electronic device-detected or clinical atrial fibrillation from enrollment to last follow-up (2 years)
Primary Inappropriate device therapy inappropriate ATP or shock from enrollment to last follow-up (2 years)
Secondary Number of Participants with complications associated with atrial fibrillation thromboembolic events, heart failure from enrollment to last follow-up (2 years)
Secondary Number of Participants with ventricular arrhythmia cardiac implantable electronic device-detected or clinical ventricular arrhythmia from enrollment to last follow-up (2 years)
Secondary Number of Participants with major adverse composite events cardiac death, all cuase death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure from enrollment to last follow-up (2 years)
Secondary atrial lead sensing stability Atrioventricular synchrony ratio from enrollment to last follow-up (2 years)
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