Atrial Sensing Capability for Better Detection of Atrial Fibrillation
A Prospective, Multicenter, Randomized Controlled Trial Comparing Atrial Sensing ON-mode of VDD Implantable Cardioverter Defibrillator(ICD) to Atrial Sensing OFF-mode of VDD ICD in Detecting Atrial Fibrillation(Smart-Control Study)
1 other identifier
interventional
640
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2019
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedOctober 4, 2021
June 1, 2021
2.6 years
April 28, 2019
September 27, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Atrial fibrillation
cardiac implantable electronic device-detected or clinical atrial fibrillation
from enrollment to last follow-up (2 years)
Inappropriate device therapy
inappropriate ATP or shock
from enrollment to last follow-up (2 years)
Secondary Outcomes (4)
Number of Participants with complications associated with atrial fibrillation
from enrollment to last follow-up (2 years)
Number of Participants with ventricular arrhythmia
from enrollment to last follow-up (2 years)
Number of Participants with major adverse composite events
from enrollment to last follow-up (2 years)
atrial lead sensing stability
from enrollment to last follow-up (2 years)
Study Arms (2)
Atrial sensing OFF mode
NO INTERVENTIONVDD-ICD programmed as atrial sensing Off mode
Atrial sensing ON mode
ACTIVE COMPARATORVDD-ICD programmed as atrial sensing ON mode
Interventions
Single lead VDD-ICD programmed as atrial sensing On mode.
Eligibility Criteria
You may qualify if:
- age ≥ 19 years
- indication for ICD implantation according to guidelines
- atrial fibrillation didn't detect by electrocardiogram or Holter test within the past 1 year from the ICD implantation, and
- CHA2DS2VASc score ≥1 point in male or ≥ 2 in female
You may not qualify if:
- persistent or permanent atrial fibrillation (AF)
- atrial fibrillation detected by electrocardiogram or Holter test within the past 1 year from the ICD implantation
- history of the catheter or surgical ablation of AF or taking antiarrhythmic drug
- scheduled to undergo heart transplant within 1 year
- life expectancy \< 1 year
- requiring atrial pacing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Biotronik SE & Co. KGcollaborator
Study Sites (28)
Sejong General Hospital
Bucheon-si, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Samsung Changwon Medical Center
Changwon, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Yeongnam University Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
GangNeung Asan Hospital
Gangneung, South Korea
National Health Insurance Service Ilsan Hospital
Goyang, South Korea
Gachon University, Donginchoen Gil Hospital
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Mediplex Sejong Hospital
Incheon, South Korea
Kosin University Gospel Hospital
Pusan, South Korea
Pusan National University Hospital
Pusan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Hallym University Medical Center-Kangnam
Seoul, South Korea
Kangbuk Samsung Medical Center
Seoul, South Korea
Koera University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
VHS Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, South Korea
Related Publications (1)
Gwag HB, Kim HR, Park SJ, Kim J, Chung TW, Choi JH, Kim JY, Park KM, On YK, Kim JS. The efficacy of single-lead implantable cardioverter-defibrillator with atrial sensing dipole to detect atrial fibrillation and to reduce inappropriate therapy according to atrial sensing ON or OFF: Rationale and design of the SMART-CONTROL study, a prospective multicenter randomized trial. Am Heart J. 2022 Sep;251:25-31. doi: 10.1016/j.ahj.2022.05.008. Epub 2022 May 12.
PMID: 35568193DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park, PhD
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2019
First Posted
May 1, 2019
Study Start
June 1, 2019
Primary Completion
December 31, 2021
Study Completion
May 31, 2023
Last Updated
October 4, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share