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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03607123
Other study ID # 2017-SR-235.A2
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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