Atrial Fibrillation With Sinus Node Dysfunction: Intensive Device Follow-up (SAFE PAF-SND)

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

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Sinus Node Dysfunction
• Intervention / Treatment: Other: programing of pacemaker; Procedure: AF ablation; Drug: Anti arryhthmic drugs

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 201129
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the Eligibility Criteria will be enrolled. The anticipated number of patients is 200.

Description

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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Other: 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).	Other: 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).	Procedure: 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).	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
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of ventricular pacing	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
symptom related to bradycardia	through study completion, an average of 2 years
AF burden	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2018
• Primary Completion (Anticipated): July 4, 2022
• Study Completion (Anticipated): July 4, 2022

Study Registration Dates

• First Submitted: July 8, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 23, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Heart Block; Atrial Fibrillation; Sick Sinus Syndrome
• Other Study ID Numbers: 2017-SR-235.A2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No