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| Name | Class |
|---|---|
| Zhejiang University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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). |
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| RFCA (Step 3) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| programing of pacemaker | Other | Different programing parameters will be set in different group/stage |
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| Measure | Description | Time Frame |
|---|---|---|
| proportion of ventricular pacing | through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| symptom related to bradycardia | through study completion, an average of 2 years | |
| AF burden | through study completion, an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who meet the Eligibility Criteria will be enrolled. The anticipated number of patients is 200.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 201129 | China |
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| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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). |
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| 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. |
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| AF ablation | Procedure | AF ablation can only be performed in Step 3 |
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| Anti arryhthmic drugs | Drug | Anti arryhthmic drugs can be prescribed in Step 2, Step3 and SAFE PAF-SND |
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| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |