Stepwise Atrial Fibrillation supprEssion Treatment in Patients With Paroxysmal Atrial Fibrillation and Sinus Node Dysfunction: Intensive Device Follow-up
Overview
- Phase
- Not Applicable
- Intervention
- programing of pacemaker
- Conditions
- Sinus Node Dysfunction
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- proportion of ventricular pacing
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Minglong Chen
Vice Director of Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University; Professor of Medicine, Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •Age from 18 - 80 years
- •Longest RR interval ≥ 3 seconds in sinus rhythm or when atrial arrhythmia (atrial fibrillation/atrial arrhythmia/atrial flutter) is converted to sinus rhythm (documented by either holter monitor or electrogram).
- •Meet the indications of permanent pacemaker implantation in patients with SND according to the 2012 ACCF/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities.
- •Evidence of paroxysmal atrial fibrillation ( two or more symptomatic episodes within 6 months)
- •Willing to sigh informed consent
Exclusion Criteria
- •Type II second-degree or three-degree atrioventricular block (in sinus rhythm)
- •Intrinsic PR interval ≥ 300 ms in sinus rhythm
- •Persistent AF（including long-standing persistent AF）
- •Severe structural heart disease(e.g. ischemic heart disease that requires revascularization, rheumatic heart disease that requires valve replacement, cardiomyopathy except hypertensive myocardial hypertrophy)
- •Work high above the ground or heavy physical labour
- •Malignant ventricular arrhythmias
- •New York Heart Association (NYHA) class III or IV
- •AF secondary to electrolyte imbalance, thyroid dysfunction, vasovagal reaction or other reversible or non-cardiac causes
- •Previous procedures dealing with AF (including radiofrequency ablation and surgical operation)
- •Cardiac implantable electronic device implantation history
Arms & Interventions
Baseline
After implantation of pacemaker, the pacing mode and the lower rate of pacemaker will be set as VDD and 50/45 bpm respectively, to get the baseline burden of atrial fibrillation without atrial pacing. Except for beta-blockers digoxin, and CCB to control heart rate, anti-arrhythmic drugs (AAD) will not be prescribed. Patients who can not tolerate will drop out. After follow-up of at least 3 month, patients with AF lasting longer than one minute detected by pacemaker will go to next group / stage (Atrial Pacing, Step1).
Intervention: programing of pacemaker
Atrial Pacing (Step 1)
After Baseline and after follow-up of at least 3 month, patients with AF lasting longer than one minute detected by pacemaker will come to this group /stage (Atrial Pacing). At this stage, the pacing mode and the lower rate of pacemaker will be set as DDD and 70/60 bpm respectively, to perform relatively high-rate atrial pacing. Except for beta-blockers digoxin, and CCB to control heart rate, anti-arrhythmic drugs (AAD) will not be prescribed. After follow-up of at least 3 month, patients with AF lasting longer than one minute detected by pacemaker will go to next group/stage (AAD, Step1).
Intervention: programing of pacemaker
AAD (Step 2)
After Step 1, and after follow-up of at least 3 month, patients with AF lasting longer than one minute detected by pacemaker will come to this group/stage. Anti-arrhythmic drugs including propafenone, amiodarone and dronedarone will be prescribed. After follow-up of at least 6 month, patients with AF lasting longer than one minute detected by pacemaker will go to next group/stage (RFCA, Step3).
Intervention: AF ablation
RFCA (Step 3)
After Step 2, and after follow-up of at least 6 month, patients with AF lasting longer than one minute detected by pacemaker will come to this group/stage (RFCA, Step3). Patients will receive catheter ablation of AF, up to patients' willingness. After follow-up of at least 12 month, patients without AF lasting longer than one minute detected by pacemaker will go to next group/stage (SAFE PAF-SND II).
Intervention: AF ablation
RFCA (Step 3)
After Step 2, and after follow-up of at least 6 month, patients with AF lasting longer than one minute detected by pacemaker will come to this group/stage (RFCA, Step3). Patients will receive catheter ablation of AF, up to patients' willingness. After follow-up of at least 12 month, patients without AF lasting longer than one minute detected by pacemaker will go to next group/stage (SAFE PAF-SND II).
Intervention: Anti arryhthmic drugs
SAFE PAF-SND II
After RFCA, and after follow-up of at least 12 month, patients without AF lasting longer than one minute detected by pacemaker will come to this group/stage (SAFE PAF-SND II). At this stage, the pacing mode and the lower rate of pacemaker will be set as VDD and 40 bpm respectively. If the patient can not tolerate, the the pacing mode and the lower rate of pacemaker will be set as DDD/DDDR and 60 bpm. If the patient has no symptom related to bradycardia, he/she will be followed up until the end of this study.
Intervention: programing of pacemaker
SAFE PAF-SND II
After RFCA, and after follow-up of at least 12 month, patients without AF lasting longer than one minute detected by pacemaker will come to this group/stage (SAFE PAF-SND II). At this stage, the pacing mode and the lower rate of pacemaker will be set as VDD and 40 bpm respectively. If the patient can not tolerate, the the pacing mode and the lower rate of pacemaker will be set as DDD/DDDR and 60 bpm. If the patient has no symptom related to bradycardia, he/she will be followed up until the end of this study.
Intervention: AF ablation
Outcomes
Primary Outcomes
proportion of ventricular pacing
Time Frame: through study completion, an average of 2 years
Secondary Outcomes
- symptom related to bradycardia(through study completion, an average of 2 years)
- AF burden(through study completion, an average of 2 years)