Right Atrial Pacing versus Left Atrial Pacing to Prevent Development of Paroxysmal Atrial Fibrillation in Patients with Sick Sinus Syndrome or Anti-arrhythmic Drug-induced Bradycardia.

Right Atrial Pacing versus Left Atrial Pacing to Prevent Development of Paroxysmal Atrial Fibrillation in Patients with Sick Sinus Syndrome or Anti-arrhythmic Drug-induced Bradycardia. - Riverleft

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39873

Enrollment

330

Registered

2012-10-16

Start date

2013-01-23

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

incidental atrial fibrillation Paroxysmal atrial fibrillation

Interventions

Patients will get a pacemaker implanted and the pacemaker lead will either be placed near the left atrium (coronary sinus) or in the right atrium (right atrial appendage).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Written informed consent signed by patient - Sick Sinus Syndrome or anti-arrhythmic drug-induced bradycardia - Documented paroxysmal atrial fibrillation with a duration of >= 30 seconds in the past 6 months - 18 years old or older

Exclusion criteria

Exclusion criteria: - Life expectancy of = 250 umol/l - Participation in another investigational drug or device study

Design outcomes

Primary

Measure	Time frame
Primary endpoint of this study is development of paroxysmal atrial fibrillation despite left or right atrial stimulation. The follow up period is 36 months. At specific time intervals patient will be called by the investigator in order to check whether atrial fibrillation has occurred. Patients atrial rhythm will continuously be monitored by Home Monitoring® supplied by the pacemaker manufacturer.	—

Measure

Time frame

Primary endpoint of this study is development of paroxysmal atrial fibrillation despite left or right atrial stimulation. The follow up period is 36 months. At specific time intervals patient will be called by the investigator in order to check whether atrial fibrillation has occurred. Patients atrial rhythm will continuously be monitored by Home Monitoring® supplied by the pacemaker manufacturer.

—

Secondary

Measure	Time frame
Quality of Life assessment will be performed at specific time intervals.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)