Atrial Sensing Capability for Better Detection of Atrial Fibrillation

September 27, 2021 updated by: Samsung Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

640

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Recruiting
        • Sejong General Hospital
        • Contact:
          • Sang Weon Park
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
          • Dae Kyeong Kim
      • Changwon, Korea, Republic of
        • Recruiting
        • Samsung Changwon Medical Center
        • Contact:
          • Hye Bin Gwag
      • Cheongju, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital
        • Contact:
          • Dae In lee
      • Chuncheon, Korea, Republic of
        • Recruiting
        • Kangwon National University Hospital
        • Contact:
          • Kwang Jin Chun
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
          • Jongmin Hwang
      • Daegu, Korea, Republic of
        • Recruiting
        • Daegu Catholic University Medical Center
        • Contact:
          • Young Soo Lee
      • Daegu, Korea, Republic of
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
          • Myung Hwan Bae
      • Daegu, Korea, Republic of
        • Recruiting
        • Yeongnam University Medical Center
        • Contact:
          • Dong-Gu Shin
      • Daejeon, Korea, Republic of
        • Recruiting
        • Chungnam National University Hospital
        • Contact:
          • Minsu Kim
      • Gangneung, Korea, Republic of
        • Recruiting
        • Gangneung Asan Hospital
        • Contact:
          • Sang-Yong You
      • Goyang, Korea, Republic of
        • Recruiting
        • National Health Insurance Service Ilsan Hospital
        • Contact:
          • Hanchul Lee
      • Incheon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
        • Contact:
          • Dae Hyeok Kim
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University, Donginchoen Gil Hospital
        • Contact:
          • Yae Min Park
      • Incheon, Korea, Republic of
        • Recruiting
        • Mediplex Sejong Hospital
        • Contact:
          • Dong-Hyeok Kim
      • Pusan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
        • Contact:
          • Jinhee Ahn
      • Pusan, Korea, Republic of
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
          • Sung Il Im
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Il-young Oh
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Myung-jin Cha
      • Seoul, Korea, Republic of
        • Recruiting
        • VHS Medical Center
        • Contact:
          • Jin Kyung Hwang
      • Seoul, Korea, Republic of
        • Recruiting
        • Hallym University Medical Center-Kangnam
        • Contact:
          • Dong Geum Shin
      • Seoul, Korea, Republic of
        • Recruiting
        • Kangbuk Samsung Medical Center
        • Contact:
          • Sung Ho Lee
      • Seoul, Korea, Republic of
        • Recruiting
        • Koera University Guro Hospital
        • Contact:
          • Seung-Young Roh
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
          • Jin-Bae Kim
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
        • Contact:
          • Woo-Hyun Lim
      • Seoul, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
          • Sung-Hwan Kim
      • Suwon, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, St. Vincent's Hospital
        • Contact:
          • You mi Hwang
      • Suwon, Korea, Republic of
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Gyo-Seung Hwang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Atrial sensing OFF mode
VDD-ICD programmed as atrial sensing Off mode
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation
Time Frame: from enrollment to last follow-up (2 years)
cardiac implantable electronic device-detected or clinical atrial fibrillation
from enrollment to last follow-up (2 years)
Inappropriate device therapy
Time Frame: from enrollment to last follow-up (2 years)
inappropriate ATP or shock
from enrollment to last follow-up (2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with complications associated with atrial fibrillation
Time Frame: from enrollment to last follow-up (2 years)
thromboembolic events, heart failure
from enrollment to last follow-up (2 years)
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
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)
cardiac death, all cuase death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure
from enrollment to last follow-up (2 years)
atrial lead sensing stability
Time Frame: from enrollment to last follow-up (2 years)
Atrioventricular synchrony ratio
from enrollment to last follow-up (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Biotronik SE & Co. KG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

April 28, 2019

First Submitted That Met QC Criteria

April 28, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC-2019-01-149-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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