Clinical trial NCT03932604: Atrial Sensing Capability for Better Detection of Atrial Fibrillation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Implantable Cardioverter Defibrillator
Atrial Fibrillation
Cardiac Event
Cardiac Arrhythmia
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2019-05-01
Enrollment: 640
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomly assigned as atrial sensing ON or Off mode
Primary purpose: SCREENING

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation
timeFrame: from enrollment to last follow-up (2 years)
measure: Inappropriate device therapy
timeFrame: from enrollment to last follow-up (2 years)
Secondary outcomes:
measure: Number of Participants with complications associated with atrial fibrillation
timeFrame: from enrollment to last follow-up (2 years)
measure: Number of Participants with ventricular arrhythmia
timeFrame: from enrollment to last follow-up (2 years)
measure: Number of Participants with major adverse composite events
timeFrame: from enrollment to last follow-up (2 years)
measure: atrial lead sensing stability
timeFrame: from enrollment to last follow-up (2 years)
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Changwon
country: Korea, Republic of
facility: Samsung Changwon Medical Center
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeongnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University, Donginchoen Gil Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Mediplex Sejong Hospital
city: Pusan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Medical Center-Kangnam
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Koera University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
Study officials:
affiliation: Samsung Medical Center
name: Seung-Jung Park, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.