Implantable Cardioverter DefibrillatorNCT03932604
Atrial Sensing Capability for Better Detection of Atrial Fibrillation
A study testing Atrial sensing On mode in people with Implantable Cardioverter Defibrillator and Atrial Fibrillation, run by Samsung Medical Center at 28 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Implantable Cardioverter Defibrillator, Atrial Fibrillation, Cardiac Event
- What is being tested?
- Atrial sensing On mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 28 sitesSouth Korea
- Study dates
- 1 Jun 2019to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
South Korea28 sites, 28 recruiting
- Recruiting
Sejong General Hospital
Bucheon-si
Sang Weon Park
- Recruiting
Inje University Busan Paik Hospital
Busan
Dae Kyeong Kim
- Recruiting
Samsung Changwon Medical Center
Changwon
Hye Bin Gwag
- Recruiting
Chungbuk National University Hospital
Cheongju-si
Dae In lee
- Recruiting
Kangwon National University Hospital
Chuncheon
Kwang Jin Chun
- Recruiting
Daegu Catholic University Medical Center
Daegu
Young Soo Lee
- Recruiting
Keimyung University Dongsan Medical Center
Daegu
Jongmin Hwang
- Recruiting
Kyungpook National University Hospital
Daegu
Myung Hwan Bae
- Recruiting
Yeongnam University Medical Center
Daegu
Dong-Gu Shin
- Recruiting
Chungnam National University Hospital
Daejeon
Minsu Kim
- Recruiting
GangNeung Asan Hospital
Gangneung
Sang-Yong You
- Recruiting
National Health Insurance Service Ilsan Hospital
Goyang
Hanchul Lee
- Recruiting
Gachon University, Donginchoen Gil Hospital
Incheon
Yae Min Park
- Recruiting
Inha University Hospital
Incheon
Dae Hyeok Kim
- Recruiting
Mediplex Sejong Hospital
Incheon
Dong-Hyeok Kim
- Recruiting
Kosin University Gospel Hospital
Pusan
Sung Il Im
- Recruiting
Pusan National University Hospital
Pusan
Jinhee Ahn
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Il-young Oh
- Recruiting
Hallym University Medical Center-Kangnam
Seoul
Dong Geum Shin
- Recruiting
Kangbuk Samsung Medical Center
Seoul
Sung Ho Lee
- Recruiting
Koera University Guro Hospital
Seoul
Seung-Young Roh
- Recruiting
Kyung Hee University Hospital
Seoul
Jin-Bae Kim
- Recruiting
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
Woo-Hyun Lim
- Recruiting
Seoul National University Hospital
Seoul
Myung-jin Cha
- Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Sung-Hwan Kim
- Recruiting
VHS Medical Center
Seoul
Jin Kyung Hwang
- Recruiting
Ajou University Hospital
Suwon
Gyo-Seung Hwang
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon
You mi Hwang
About this study
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)
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.
Read the 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.
- Conditions
- Implantable Cardioverter Defibrillator, Atrial Fibrillation, Cardiac Event, Cardiac Arrhythmia
- Being tested
- Atrial sensing On mode
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial sensing On modeDevice
Single lead VDD-ICD programmed as atrial sensing On mode.
| Study group | Role | What they receive |
|---|---|---|
| Atrial sensing OFF mode | No intervention | VDD-ICD programmed as atrial sensing Off mode |
| Atrial sensing ON mode | Active comparator | VDD-ICD programmed as atrial sensing ON mode Receives: Device: Atrial sensing On mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation
cardiac implantable electronic device-detected or clinical atrial fibrillation
Measured: from enrollment to last follow-up (2 years)
Inappropriate device therapy
inappropriate ATP or shock
Measured: from enrollment to last follow-up (2 years)
Secondary outcomes (4)
Number of Participants with complications associated with atrial fibrillation
thromboembolic events, heart failure
Measured: from enrollment to last follow-up (2 years)
Number of Participants with ventricular arrhythmia
cardiac implantable electronic device-detected or clinical ventricular arrhythmia
Measured: from enrollment to last follow-up (2 years)
Number of Participants with major adverse composite events
cardiac death, all cuase death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure
Measured: from enrollment to last follow-up (2 years)
atrial lead sensing stability
Atrioventricular synchrony ratio
Measured: from enrollment to last follow-up (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Jun 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implantable Cardioverter DefibrillatorStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned as atrial sensing ON or Off mode
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
- Investigators
- Seung-Jung Park, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932604
- Sponsor's protocol ID
- SMC-2019-01-149-03
- Status last verified
- Jun 2021
- First submitted
- 28 Apr 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35568193
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03932604
- Acronym / sponsor ID
- SMC-2019-01-149-03
- Conditions
- Implantable Cardioverter Defibrillator, Atrial Fibrillation, Cardiac Event, Cardiac Arrhythmia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomly assigned as atrial sensing ON or Off mode
| Arm | Type | Receives |
|---|---|---|
| Atrial sensing OFF mode | No intervention | –VDD-ICD programmed as atrial sensing Off mode |
| Atrial sensing ON mode | Active comparator | Device: Atrial sensing On modeVDD-ICD programmed as atrial sensing ON mode |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrial sensing On modeSingle lead VDD-ICD programmed as atrial sensing On mode. | Device | Atrial sensing ON mode |
Primary outcome
Atrial fibrillation
Time frame: from enrollment to last follow-up (2 years)
cardiac implantable electronic device-detected or clinical atrial fibrillation
Inappropriate device therapy
Time frame: from enrollment to last follow-up (2 years)
inappropriate ATP or shock
4 secondary outcomes
Number of Participants with complications associated with atrial fibrillation
Time frame: from enrollment to last follow-up (2 years)
Number of Participants with ventricular arrhythmia
Time frame: from enrollment to last follow-up (2 years)
Number of Participants with major adverse composite events
Time frame: from enrollment to last follow-up (2 years)
atrial lead sensing stability
Time frame: from enrollment to last follow-up (2 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Derived from this study: PubMed 35568193Gwag 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jung Park, PhD principal investigator
Samsung Medical Center
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrial sensing On mode in people with Implantable Cardioverter Defibrillator and Atrial Fibrillation, run by Samsung Medical Center at 28 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung-Jung Park, PhD (+82-2-3410-7145, orthovics@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation (time frame: from enrollment to last follow-up (2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.