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Atrial Sensing Capability for Better Detection of Atrial Fibrillation
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Implantable Cardioverter Defibrillator Atrial Fibrillation Cardiac Event Cardiac Arrhythmia | Device: Atrial sensing On mode | Not Applicable |
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.
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 280 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Patients are randomly assigned as atrial sensing ON or Off mode |
| Masking: | None (Open Label) |
| Primary Purpose: | Screening |
| 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) |
| Estimated Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | May 31, 2021 |
| Estimated Study Completion Date : | May 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Atrial sensing OFF mode
VDD-ICD programmed as atrial sensing Off mode
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Active Comparator: Atrial sensing ON mode
VDD-ICD programmed as atrial sensing ON mode
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Device: Atrial sensing On mode
Single lead VDD-ICD programmed as atrial sensing On mode.
|
- Atrial fibrillation [ Time Frame: from enrollment to last follow-up (2 years) ]cardiac implantable electronic device-detected or clinical atrial fibrillation
- Number of Participants with inappropriate shock [ Time Frame: from enrollment to last follow-up (2 years) ]Any ICD therapy not delivered for ventricular tachycardia or ventricular fibrillation
- Number of Participants with complications associated with atrial fibrillation [ Time Frame: from enrollment to last follow-up (2 years) ]thromboembolic events, heart failure
- Number of Participants with ventricular arrhythmia [ Time Frame: from enrollment to last follow-up (2 years) ]cardiac implantable electronic device-detected or clinical ventricular arrhythmia
- Number of Participants with major adverse composite events [ Time Frame: from enrollment to last follow-up (2 years) ]cardiac death, all cuase death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure
- atrial lead sensing stability [ Time Frame: from enrollment to last follow-up (2 years) ]Atrioventricular synchrony ratio
| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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: Seung-Jung Park, PhD | +82-2-3410-7145 | orthovics@gmail.com |
Show 28 study locations
| Principal Investigator: | Seung-Jung Park, PhD | Samsung Medical Center |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 28, 2019 | ||||
| First Posted Date ICMJE | May 1, 2019 | ||||
| Last Update Posted Date | May 2, 2019 | ||||
| Estimated Study Start Date ICMJE | June 1, 2019 | ||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Atrial fibrillation [ Time Frame: from enrollment to last follow-up (2 years) ] cardiac implantable electronic device-detected or clinical atrial fibrillation
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Atrial Sensing Capability for Better Detection of Atrial Fibrillation | ||||
| Official Title ICMJE | 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) | ||||
| Brief Summary | This prospective multi center randomized controlled study aims to determine whether the comparison of atrial fibrillation detection 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. . |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Patients are randomly assigned as atrial sensing ON or Off mode Masking: None (Open Label)Primary Purpose: Screening |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Atrial sensing On mode
Single lead VDD-ICD programmed as atrial sensing On mode.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
280 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 31, 2023 | ||||
| Estimated Primary Completion Date | May 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03932604 | ||||
| Other Study ID Numbers ICMJE | SMC-2019-01-149-03 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Samsung Medical Center | ||||
| Study Sponsor ICMJE | Samsung Medical Center | ||||
| Collaborators ICMJE | Biotronik SE & Co. KG | ||||
| Investigators ICMJE |
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| PRS Account | Samsung Medical Center | ||||
| Verification Date | April 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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