Managed ventricular pacing and atrial anti-tachycardia pacing for prevention of asymptomatic cerebral infarction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005316

Enrollment

120

Registered

2020-08-20

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

None listed

Interventions

Procedure/Surgery : Pacemaker & Paroxysmal AF -&gt

Baseline Brain MRI -&gt

Randomization -&gt

DDDR pacing (+Managed ventricular pacing) N=60 -&gt

DDDR (+Managed ventricular pacing) + Anti-tachycardia pacing N=60 Primary endpoint-&gt

Silent brain infarction in 2-years follow up brain MRI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients with age between 18-80 years AND - Patients had dual-chamber pacemaker AND - Patients had paroxysmal AF (either clinical AF or subclinical AF detected in the intracardiac device > 6 minutes) documented before pacemaker implantation or within 6 months after pacemaker implantation AND - Able and willing to provide written informed consent to RFCA and participation in this investigation

Exclusion criteria

Exclusion criteria: - Patients refusing participation in the study. - Age< 18 years old or > 80 years old - pregnant woman of child-bearing age with a positive pregnancy test before treatment - Patients with prior history of ischemic stroke or transient ischemic attack - Persistent or permanent AF - Prior PV isolation or surgical ablation of AF or planned for ablation within 3 months - Patients with acute coronary syndrome or valve surgery within 3 months or planned surgery within 3 months - Preexisting cardiac implantable device (pacemaker, ICD, or CRT) without ATP function - Contraindication to the MRI imaging - Presence of mechanical prosthetic valve - Significant coronary artery disease requiring coronary intervention, bypass surgery, or continuous antiplatelet therapy - LV ejection fraction < 35% who indicated for ICD or CRT - Life expectancy less than 1 year

Design outcomes

Primary

Measure	Time frame
Development of clinical ischemic stroke or new silent cerebral infarction in the 2-years follow-up brain MRI image	—

Secondary

Measure	Time frame
- Composite of clinical ischemic stroke, new silent cerebral infarction, and subclinical AF =24 hours during follow-up. - Development of asymptomatic cerebral infarction, white matter hyperintensity, and microbleed in the 2-years follow-up brain MRI image - Clinical ischemic stroke during follow-up - Incidence of subclinical AF = 6 minutes - Incidence of subclinical AF = 5.5 hours - Incidence of subclinical AF = 24 hours - Incidence of clinical AF documented on the 12-lead or holter ECG. - Progression to the persistent AF (at least 7 consecutive days with 22 hours of device-recorded AF per day or at least 1 day with an episode of AF lasting at least 22 hours that was interrupted with an electrical or chemical cardioversion) - Success rate of anti-tachycardia pacing - Percentage of atrial and ventricular pacing on each follow-up interrogation. - Percentage of AF burden on each follow-up interrogation.	—

Measure

Time frame

- Composite of clinical ischemic stroke, new silent cerebral infarction, and subclinical AF =24 hours during follow-up. - Development of asymptomatic cerebral infarction, white matter hyperintensity, and microbleed in the 2-years follow-up brain MRI image - Clinical ischemic stroke during follow-up - Incidence of subclinical AF = 6 minutes - Incidence of subclinical AF = 5.5 hours - Incidence of subclinical AF = 24 hours - Incidence of clinical AF documented on the 12-lead or holter ECG. - Progression to the persistent AF (at least 7 consecutive days with 22 hours of device-recorded AF per day or at least 1 day with an episode of AF lasting at least 22 hours that was interrupted with an electrical or chemical cardioversion) - Success rate of anti-tachycardia pacing - Percentage of atrial and ventricular pacing on each follow-up interrogation. - Percentage of AF burden on each follow-up interrogation.

—

Countries

Korea, Republic of

Contacts

Public ContactKee-Joon Choi

Asan Medical Center

Outcome results