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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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03932604
Enrollment
640
Registered
2019-05-01
Start date
2019-06-01
Completion date
2023-05-31
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Cardiac Arrhythmia, Cardiac Event, Implantable Cardioverter Defibrillator

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.

Interventions

DEVICEAtrial sensing On mode

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

Sponsors

Biotronik SE & Co. KG
CollaboratorINDUSTRY
Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

Patients are randomly assigned as atrial sensing ON or Off mode

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Atrial fibrillationfrom enrollment to last follow-up (2 years)cardiac implantable electronic device-detected or clinical atrial fibrillation
Inappropriate device therapyfrom enrollment to last follow-up (2 years)inappropriate ATP or shock

Secondary

MeasureTime frameDescription
Number of Participants with complications associated with atrial fibrillationfrom enrollment to last follow-up (2 years)thromboembolic events, heart failure
Number of Participants with ventricular arrhythmiafrom enrollment to last follow-up (2 years)cardiac implantable electronic device-detected or clinical ventricular arrhythmia
Number of Participants with major adverse composite eventsfrom 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 stabilityfrom enrollment to last follow-up (2 years)Atrioventricular synchrony ratio

Countries

South Korea

Contacts

Primary ContactSeung-Jung Park, PhD
orthovics@gmail.com+82-2-3410-7145

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026