Atrial Fibrillation With Sinus Node Dysfunction: Intensive Device Follow-up
NCT ID: NCT03607123
Last Updated: 2018-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2018-07-04
2022-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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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).
programing of pacemaker
Different programing parameters will be set in different group/stage
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).
programing of pacemaker
Different programing parameters will be set in different group/stage
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).
AF ablation
AF ablation can only be performed in Step 3
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).
AF ablation
AF ablation can only be performed in Step 3
Anti arryhthmic drugs
Anti arryhthmic drugs can be prescribed in Step 2, Step3 and SAFE PAF-SND
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.
programing of pacemaker
Different programing parameters will be set in different group/stage
AF ablation
AF ablation can only be performed in Step 3
Interventions
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programing of pacemaker
Different programing parameters will be set in different group/stage
AF ablation
AF ablation can only be performed in Step 3
Anti arryhthmic drugs
Anti arryhthmic drugs can be prescribed in Step 2, Step3 and SAFE PAF-SND
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Severe hepatic and renal dysfunction(serum creatinine above the upper normal limit of the center, or chronic renal dysfunction ; ALT or AST more than 2 times the upper normal limit of the center, or bilirubin more than 2 times the upper normal limit of the center, or hepatic cirrhosis)
* Contraindication to propafenone/amiodarone/dronedarone(except bradycardia)
* Contraindication to oral anticoagulants
* Women who are pregnant
* Presence of malignant tumor
* Severe coagulation disorder (without any anticoagulation treatment)
* The investigators do not think the patient is eligible for this study
* Patient is unwilling to cooperate with the study procedures
18 Years
80 Years
ALL
No
Sponsors
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Zhejiang University
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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Minglong Chen
Vice Director of Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University; Professor of Medicine, Nanjing Medical University
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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2017-SR-235.A2
Identifier Type: -
Identifier Source: org_study_id