Atrial Sensing Capability for Better Detection of Atrial Fibrillation

Last updated: September 27, 2021
Sponsor: Samsung Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Fast Heart Rate (Tachycardia)

Arrhythmia

Treatment

N/A

Clinical Study ID

NCT03932604
SMC-2019-01-149-03
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. persistent or permanent atrial fibrillation (AF)
  2. atrial fibrillation detected by electrocardiogram or Holter test within the past 1year 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

Study Design

Total Participants: 640
Study Start date:
June 01, 2019
Estimated Completion Date:
May 31, 2023

Study 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.

Connect with a study center

  • Sejong General Hospital

    Bucheon,
    Korea, Republic of

    Active - Recruiting

  • Inje University Busan Paik Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Samsung Changwon Medical Center

    Changwon,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju,
    Korea, Republic of

    Active - Recruiting

  • Kangwon National University Hospital

    Chuncheon,
    Korea, Republic of

    Active - Recruiting

  • Daegu Catholic University Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Yeongnam University Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • GangNeung Asan Hospital

    Gangneung,
    Korea, Republic of

    Active - Recruiting

  • National Health Insurance Service Ilsan Hospital

    Goyang,
    Korea, Republic of

    Active - Recruiting

  • Gachon University, Donginchoen Gil Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Inha University Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Mediplex Sejong Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

  • Kosin University Gospel Hospital

    Pusan,
    Korea, Republic of

    Active - Recruiting

  • Pusan National University Hospital

    Pusan,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam,
    Korea, Republic of

    Active - Recruiting

  • Hallym University Medical Center-Kangnam

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Koera University Guro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • VHS Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

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