Atrial Sensing Capability for Better Detection of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932604
• Other study ID #: SMC-2019-01-149-03
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2021
• Source: Samsung Medical Center
• Contact: Seung-Jung Park, PhD
• Phone: +82-2-3410-7145
• Email: orthovics[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Atrial sensing On mode
Single lead VDD-ICD programmed as atrial sensing On mode.

Locations

Country	Name	City	State
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 (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Biotronik SE & Co. KG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation	cardiac implantable electronic device-detected or clinical atrial fibrillation	from enrollment to last follow-up (2 years)
Primary	Inappropriate device therapy	inappropriate ATP or shock	from enrollment to last follow-up (2 years)
Secondary	Number of Participants with complications associated with atrial fibrillation	thromboembolic events, heart failure	from enrollment to last follow-up (2 years)
Secondary	Number of Participants with ventricular arrhythmia	cardiac implantable electronic device-detected or clinical ventricular arrhythmia	from enrollment to last follow-up (2 years)
Secondary	Number of Participants with major adverse composite events	cardiac death, all cuase death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure	from enrollment to last follow-up (2 years)
Secondary	atrial lead sensing stability	Atrioventricular synchrony ratio	from enrollment to last follow-up (2 years)