Atrial Sensing Capability for Better Detection of Atrial Fibrillation

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03932604
• Collaborator: Biotronik SE & Co. KG (Industry)
• Enrollment: 640
• Locations: 28
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site: 22.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Implantable Cardioverter Defibrillator; Atrial Fibrillation; Cardiac Event; Cardiac Arrhythmia	Device: Atrial sensing On mode	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. As the second phase, we also plan to compare inappropriate therapy rate according to atrial sensing status of VDD ICD.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 640 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients are randomly assigned as atrial sensing ON or Off modePatients 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)
• Actual Study Start Date: Jun 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Atrial fibrillation [from enrollment to last follow-up (2 years)]

   cardiac implantable electronic device-detected or clinical atrial fibrillation

2. Inappropriate device therapy [from enrollment to last follow-up (2 years)]

   inappropriate ATP or shock

Secondary Outcome Measures

1. Number of Participants with complications associated with atrial fibrillation [from enrollment to last follow-up (2 years)]

   thromboembolic events, heart failure

2. Number of Participants with ventricular arrhythmia [from enrollment to last follow-up (2 years)]

   cardiac implantable electronic device-detected or clinical ventricular arrhythmia

3. Number of Participants with major adverse composite events [from enrollment to last follow-up (2 years)]

   cardiac death, all cuase death, stroke, atrial fibrillation or flutter, ventricular tachyarrhythmia, hospitalization for heart failure

4. atrial lead sensing stability [from enrollment to last follow-up (2 years)]

   Atrioventricular synchrony ratio

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sejong General Hospital	Bucheon		Korea, Republic of
2	Inje University Busan Paik Hospital	Busan		Korea, Republic of
3	Samsung Changwon Medical Center	Changwon		Korea, Republic of
4	Chungbuk National University Hospital	Cheongju		Korea, Republic of
5	Kangwon National University Hospital	Chuncheon		Korea, Republic of
6	Daegu Catholic University Medical Center	Daegu		Korea, Republic of
7	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
8	Kyungpook National University Hospital	Daegu		Korea, Republic of
9	Yeongnam University Medical Center	Daegu		Korea, Republic of
10	Chungnam National University Hospital	Daejeon		Korea, Republic of
11	GangNeung Asan Hospital	Gangneung		Korea, Republic of
12	National Health Insurance Service Ilsan Hospital	Goyang		Korea, Republic of
13	Gachon University, Donginchoen Gil Hospital	Incheon		Korea, Republic of
14	Inha University Hospital	Incheon		Korea, Republic of
15	Mediplex Sejong Hospital	Incheon		Korea, Republic of
16	Kosin University Gospel Hospital	Pusan		Korea, Republic of
17	Pusan National University Hospital	Pusan		Korea, Republic of
18	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of
19	Hallym University Medical Center-Kangnam	Seoul		Korea, Republic of
20	Kangbuk Samsung Medical Center	Seoul		Korea, Republic of
21	Koera University Guro Hospital	Seoul		Korea, Republic of
22	Kyung Hee University Hospital	Seoul		Korea, Republic of
23	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul		Korea, Republic of
24	Seoul National University Hospital	Seoul		Korea, Republic of
25	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of
26	VHS Medical Center	Seoul		Korea, Republic of
27	Ajou University Hospital	Suwon		Korea, Republic of
28	The Catholic University of Korea, St. Vincent's Hospital	Suwon		Korea, Republic of

Sponsors and Collaborators

• Samsung Medical Center
• Biotronik SE & Co. KG

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03932604
• Other Study ID Numbers: SMC-2019-01-149-03
• First Posted: May 1, 2019
• Last Update Posted: Oct 4, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Oct 4, 2021