Sinus Node DysfunctionSAFE PAF-SNDNCT03607123
Atrial Fibrillation With Sinus Node Dysfunction: Intensive Device Follow-up
An observational study of Sinus Node Dysfunction and Atrial Fibrillation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sinus Node Dysfunction, Atrial Fibrillation
- What is being tested?
- programing of pacemaker, AF ablation and Anti arryhthmic drugs
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2018to 4 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet the Eligibility Criteria will be enrolled. The anticipated number of patients is 200.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 201129
About this study
Official title: 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.
- Conditions
- Sinus Node Dysfunction, Atrial Fibrillation
- Being tested
- programing of pacemaker, AF ablation, Anti arryhthmic drugs
- Medical subject headings
- Sick Sinus Syndrome, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
programing of pacemakerOther
Different programing parameters will be set in different group/stage
AF ablationProcedure or surgery
AF ablation can only be performed in Step 3
Anti arryhthmic drugsDrug
Anti arryhthmic drugs can be prescribed in Step 2, Step3 and SAFE PAF-SND
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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. Receives: Other: programing of pacemaker; Procedure: AF ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of ventricular pacing
Measured: through study completion, an average of 2 years
Secondary outcomes (2)
symptom related to bradycardia
Measured: through study completion, an average of 2 years
AF burden
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start4 Jul 2018
- Primary completion4 Jul 2022 (estimated)
- Study completion4 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Node DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Principal investigator, Minglong Chen, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607123
- Sponsor's protocol ID
- 2017-SR-235.A2
- Acronym
- SAFE PAF-SND
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise Atrial Fibrillation supprEssion Treatment in Patients With Paroxysmal Atrial Fibrillation and Sinus Node Dysfunction: Intensive Device Follow-up
- ClinicalTrials.gov ID
- NCT03607123
- Acronym / sponsor ID
- SAFE PAF-SND / 2017-SR-235.A2
- Conditions
- Sinus Node Dysfunction, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 4 Jul 2022 (estimated)
- Study completion
- 4 Jul 2022 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Baseline | – | Other: programing of pacemakerAfter 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). |
| Atrial Pacing (Step 1) | – | Other: programing of pacemakerAfter 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). |
| AAD (Step 2) | – | Procedure: AF ablationAfter 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). |
| RFCA (Step 3) | – | Procedure: AF ablation, Drug: Anti arryhthmic drugsAfter 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). |
| SAFE PAF-SND II | – | Other: programing of pacemaker, Procedure: AF ablationAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet the Eligibility Criteria will be enrolled. The anticipated number of patients is 200.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| programing of pacemakerDifferent programing parameters will be set in different group/stage | Other | Atrial Pacing (Step 1), Baseline, SAFE PAF-SND II |
| AF ablationAF ablation can only be performed in Step 3 | Procedure or surgery | AAD (Step 2), RFCA (Step 3), SAFE PAF-SND II |
| Anti arryhthmic drugsAnti arryhthmic drugs can be prescribed in Step 2, Step3 and SAFE PAF-SND | Drug | RFCA (Step 3) |
Primary outcome
proportion of ventricular pacing
Time frame: through study completion, an average of 2 years
2 secondary outcomes
symptom related to bradycardia
Time frame: through study completion, an average of 2 years
AF burden
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinus Node Dysfunction and Atrial Fibrillation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of ventricular pacing (time frame: through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018; AzTrials last refreshed its copy on 27 Oct 2026.