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

Atrial Fibrillation Clinical Trial

— SAFE PAF-SND  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03607123
• Other study ID #: 2017-SR-235.A2
• Status: Active, not recruiting
• Start date: July 4, 2018
• Est. completion date: July 4, 2022

Study information

• Verified date: July 2018
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 4, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

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

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of ventricular pacing		through study completion, an average of 2 years
Secondary	symptom related to bradycardia		through study completion, an average of 2 years
Secondary	AF burden		through study completion, an average of 2 years