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

NCT03607123 | Unknown DMC

• 1 other identifier: 2017-SR-235.A2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinus Node Dysfunction; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• proportion of ventricular pacing

  through study completion, an average of 2 years

Secondary Outcomes (2)

• symptom related to bradycardia

  through study completion, an average of 2 years

• AF burden

  through study completion, an average of 2 years

Study Arms (5)

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

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

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

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; Drug: 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.

Other: programing of pacemaker; Procedure: AF ablation

Interventions

programing of pacemaker OTHER

Different programing parameters will be set in different group/stage

Atrial Pacing (Step 1); Baseline; SAFE PAF-SND II

AF ablation PROCEDURE

AF ablation can only be performed in Step 3

AAD (Step 2); RFCA (Step 3); SAFE PAF-SND II

Anti arryhthmic drugs DRUG

Anti arryhthmic drugs can be prescribed in Step 2, Step3 and SAFE PAF-SND

RFCA (Step 3)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Zhejiang University: collaborator

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 201129, China

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Division of Cardiology, The First Affiliated Hospital of Nanjing Medical University; Professor of Medicine, Nanjing Medical University

Study Record Dates

• First Submitted: July 8, 2018
• First Posted: July 31, 2018
• Study Start: July 4, 2018
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: July 31, 2018

Record last verified: 2018-07

Locations

CN (1)