NCT03607123

Atrial Fibrillation With Sinus Node Dysfunction: Intensive Device Follow-up

Stepwise Atrial Fibrillation supprEssion Treatment in Patients With Paroxysmal Atrial Fibrillation and Sinus Node Dysfunction: Intensive Device Follow-up

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study will try to access the efficacy of atrial pacing, medication and radiofrequency ablation in treating patients with paroxysmal atrial fibrillation and sinus node dysfunction; to identify the response to these treatments in patients with "functional" and organic sinus node dysfunction respectively; to explore the necessity of pacemaker implantation in patients with "functional" sinus node dysfunction. Patients who meet the inclusion criteria will receive pacemaker implantation followed by trial pacing, medication and radiofrequency ablation of AF. Device data will be analyzed to answer the question. And after follow-up of 1 year, lower rate of pacemaker will be set as 40 bpm for patients without AF. The proportion of pacing and patients' tolerance will be analyzed.

Conditions

• Sinus Node Dysfunction
• Atrial Fibrillation

Interventions

Type	Name	Description
OTHER	programing of pacemaker	Different programing parameters will be set in different group/stage
PROCEDURE	AF ablation	AF ablation can only be performed in Step 3
DRUG	Anti arryhthmic drugs	Anti arryhthmic drugs can be prescribed in Step 2, Step3 and SAFE PAF-SND

Timeline

• Start date: 2018-07-04
• Primary completion: 2022-07-04
• Completion: 2022-07-04
• First posted: 2018-07-31
• Last updated: 2018-07-31

Locations

1 site across 1 country: China