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Atrial Sensing Capability for Better Detection of Atrial Fibrillation

A prosepctive, multicenter, randomized controlled trial comparing atrial sensing ON-mode of DX-ICD to atrial sensing OFF-mode of DX-ICD in detecting atrial fibrillation (Smart-Control study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0003893
Enrollment
280
Registered
2019-05-08
Start date
2019-07-01
Completion date
Unknown
Last updated
2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : In patients who implantaed Intica 7 VR-T DX(Biotronik, Germany) ICD are randomly assgned three months after implantation. Patients with atrial sensing on can detect atrial fibrillatio

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients for the present study are those who will undergo or have undergone implantation of Intrica 7 VR-T DX ICD with atrial sensing function(Biotronik, Germany) within previous 90 days before enrollment. Inclusion criteria are as follows: 1) age = 19 years, 2) indication for ICDimplantationaccording to guidelines 3) atrial fibrillation didn't detect by ECG 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

Exclusion criteria: Patients who met any of the following criteria are excluded: 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 catheter or surgical ablation of AF or taking anti arrhythmic drug, 4) scheduled to undergo heart transplant within 1 year, 5)life expectancy < 1 year, or 6) requiring atrial pacing.

Design outcomes

Primary

MeasureTime frame
cardiac implantable electronic device-detected or clinical atrial fibrillation

Secondary

MeasureTime frame
Complications associated with atrial fibrillation;ventricular arrhythmia;major adverse composie events;atrial lead sensing stability

Countries

Korea, Republic of

Contacts

Public ContactSeung-Jung Park

Samsung Medical Center

orthovics@gmail.com+82-2-3410-3419

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026