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Atrial Sensing Capability for Better Detection of Atrial Fibrillation

  • Clinicaltrials.gov identifier

    NCT03932604

  • Recruitment Status

    Not yet recruiting

  • First Posted

    May 1, 2019

  • Last update posted

    May 2, 2019

Study Description

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.

  • Condition or Disease:Implantable Cardioverter Defibrillator
    Atrial Fibrillation
    Cardiac Event
    Cardiac Arrhythmia
  • Intervention/Treatment: Device: Atrial sensing On mode
  • Phase: N/A

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. .

Study Design

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2023

Arms and interventions

Arm Intervention/treatment
Active Comparator: Atrial sensing ON mode
VDD-ICD programmed as atrial sensing ON mode
Device: Atrial sensing On mode
Single lead VDD-ICD programmed as atrial sensing On mode.

Outcome Measures

  • Primary Outcome Measures: 1. Atrial fibrillation [ Time Frame: from enrollment to last follow-up (2 years) ]
    cardiac implantable electronic device-detected or clinical atrial fibrillation
  • Secondary Outcome Measures: 1. 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
  • 2. Number of Participants with complications associated with atrial fibrillation [ Time Frame: from enrollment to last follow-up (2 years) ]
    thromboembolic events, heart failure
  • 3. 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
  • 4. 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
  • 5. atrial lead sensing stability [ Time Frame: from enrollment to last follow-up (2 years) ]
    Atrioventricular synchrony ratio

Eligibility Criteria

  • Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Seung-Jung Park, PhD +82-2-3410-7145 orthovics@gmail.com

Locations

Korea, Republic of
Sejong General Hospital
Bucheon

Korea, Republic of
Inje University Busan Paik Hospital
Busan

Korea, Republic of
Samsung Changwon Medical Center
Changwon

Korea, Republic of
Chungbuk National University Hospital
Cheongju

Korea, Republic of
Kangwon National University Hospital
Chuncheon

Korea, Republic of
Daegu Catholic University Medical Center
Daegu

Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu

Korea, Republic of
Kyungpook National University Hospital
Daegu

Korea, Republic of
Yeongnam University Medical Center
Daegu

Korea, Republic of
Chungnam National University Hospital
Daejeon

Korea, Republic of
GangNeung Asan Hospital
Gangneung

Korea, Republic of
National Health Insurance Service Ilsan Hospital
Goyang

Korea, Republic of
Gachon University, Donginchoen Gil Hospital
Incheon

Korea, Republic of
Inha University Hospital
Incheon

Korea, Republic of
Mediplex Sejong Hospital
Incheon

Korea, Republic of
Kosin University Gospel Hospital
Pusan

Korea, Republic of
Pusan National University Hospital
Pusan

Korea, Republic of
Seoul National University Bundang Hospital
Seongnam

Korea, Republic of
Hallym University Medical Center-Kangnam
Seoul

Korea, Republic of
Kangbuk Samsung Medical Center
Seoul

Korea, Republic of
Koera University Guro Hospital
Seoul

Korea, Republic of
Kyung Hee University Hospital
Seoul

Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul

Korea, Republic of
Seoul National University Hospital
Seoul

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

Korea, Republic of
VHS Medical Center
Seoul

Korea, Republic of
Ajou University Hospital
Suwon

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

Sponsors and Collaborators

Samsung Medical Center

Biotronik SE & Co. KG

Investigators

Principal Investigator: Seung-Jung Park, PhD Samsung Medical Center

More Information

  • Responsible Party: Samsung Medical Center
  • ClinicalTrials.gov Identifier: NCT03932604 History of Changes
  • Other Study ID Numbers: SMC-2019-01-149-03
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 2, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Atrial Fibrillation Arrhythmias, Cardiac