Atrial FibrillationNCT03322085
The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical
A study testing radiofrequency ablation or cryoballoon in people with Atrial Fibrillation, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial summary
This study explored the influence of radiofrequency catheter ablation and cryoballoon ablation on atrial electrical remodeling in patients with atrial fibrillation,the relationship between atrial electrical remodeling and structural remodeling,and which indicators are associated with atrial recurrence after catheter… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- radiofrequency ablation or cryoballoon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 30 Oct 2019
- Phase
- Interventional
- 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
Who may be able to join
- paroxysmal AF episode occurs in the patient at least twice within half a year (electrocardiogram data or Holter), AF cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is ≤80 years.
Who cannot join
- patients with previous history of AF ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation), left atrium (LA) >50 mm, patients who underwent prosthetic heart valve replacement, pregnant women, patients with existing liver and kidney disease, malignant tumors or hematological system diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical Remodeling and the Relationship Between Electrical Remodeling and Structural Remodeling
This study explored the influence of radiofrequency catheter ablation and cryoballoon ablation on atrial electrical remodeling in patients with atrial fibrillation,the relationship between atrial electrical remodeling and structural remodeling,and which indicators are associated with atrial recurrence after catheter ablation.
Read the detailed description
From September 2017 to September 2019, the investigators enroll consecutive patients with symptomatic atrial fibrillation (AF) who were scheduled for an initial catheter ablation, including paroxysmal and persistent AF.Patients are divided in to three group: paroxysmal AF in radiofrequency ablation group, persistent AF in radiofrequency ablation group, and paroxysmal AF in Cryoablation group.
- Paroxysmal AF group: The p-wave duration, P wave dispersion and P wave amplitude are detected before and 24 hours after procedure.The atrial effective refractory period, refractory period dispersion, frequency adaptation and atrial conduction time were tested before and after procedure. Detect atrial electromechanical conduction time in the tissue doppler before and 1 week after procedure.
- Persistent AF group: The p-wave duration, P wave dispersion and P wave amplitude are detected 24 hours after procedure.The atrial effective refractory period, refractory period dispersion, frequency adaptation and atrial conduction time were tested after procedure. Detect atrial electromechanical conduction time in the tissue doppler 1 week after procedure.
- Method of detection of atrial electrical remodeling: 1). the measurement of surface electrocardiogram: the p-wave amplitude, P wave time duration and the p-wave duration dispersion (dP =Pmax- Pmin) of the same 12 lead electrocardiogram in the same cardiac cycle.Two cardiologists measured the value separately.The investigators record the mean value. 2). Atrial effective refractory period (AERP) measured from the high right atrium(HRA,the junction of superior vena cava and the right atrium , near the sinus node), low lateral right atrium(LLRA,the junction of inferior vena cava and the right atrium,on the right atrium free wall side), coronary sinus electrode (CS)7.8, and CS1.2 at 3 basic drive cycle lengths (CLs) of 600, 500, and 400 ms. Pacing was performed using a pulse width of 2 ms and a current output of twice the local diastolic threshold. If the latter was 2.0 milliampere (mA), the catheter was replaced and the threshold repeated. AERP was measured using an 8-beat drive train and a single extrastimulus incremented by 10 ms from a starting point of 170 ms. Every AERP was repeated 3 times, and the mean was taken. 3). At each CL, the dispersion of refractoriness was measured by subtracting the minimum from the maximum AERP across the 4 sites.
- Rate adaption of AERP: With the gradual shortening of the pacing cycle lengths, the atrial effective refractory should be shortened accordingly. The rate adaption of AERP was observed in different pacing cycle lengths.
- Atrial conduction time measured at the HRA after 30 seconds of constant pacing at a CL of 600, 500, and 400 ms. Conduction time is measured from the pacing artifact to the onset of the first initial sharp deflection recorded to the first A wave at CS1.10 and CS1.2. Total atrial conduction time=Pace HRA-Acs1.2; Right atrial conduction time=PaceHRA-Acs9.10; Left atrial conduction time=Acs9.10-Acs1.2.6). Atrial electromechanical conduction time: three sampling points are taken at lateral mitral valve(Sa1), septal mitral valve(Sa2), lateral tricuspid valve (Sa3), in the tissue doppler four-chamber view. Atrial electromechanical conduction time is measured from electrocardiogram P wave initiation to ultrasound A wave initiation. Total atrial electromechanical conduction time=T1-T3;Right atrial electromechanical conduction time=T2-T3; Light atrial electromechanical conduction time=T2-T1.
All patients fill the follow-up form before procedure. After catheter ablation therapy, all patients invited to come back to the outpatient clinic every week in the first month, and then at 2, 3, 6, 9, and 12 month to follow up. Patients received electrocardiogram and Holter monitor examination if with symptoms of palpitations. Those patients with no symptoms received electrocardiogram every month and Holter monitor examination every 6 months. Recurrence of atrial fibrillation was defined as atrial fibrillation/flutter or atrial tachycardia lasting ≥ 30 seconds 3 months after radiofrequency catheter ablation therapy. Patients who have AF recurrence within three months after therapy will not be considered for repeated radiofrequency ablation.Blood samples (routine blood, high sensitivity c-reactive protein,B-type natriuretic peptide (BNP), cystatin C,homocysteine,β2-microglobulin) and transthoracic echocardiography indexes (left atrial anterior to posterior diameter, left atrial length-diameter,left atrial transverse-diameter,left atrial volume index, mitral e', E peak, A peak, E/A,velocity time integral (VTI), left atrial ejection fraction, left atrial strain, strain rate and atrial electrical - mechanical conduction time) are recorded in all patients at each follow-up. Patients with AF recurrence must have an electrocardiogram or a 24 hour holter monitor evidence.
- Conditions
- Atrial Fibrillation
- Being tested
- radiofrequency ablation or cryoballoon
- Keywords
- atrial fibrillation, atrial electrical remodeling
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablation or cryoballoonProcedure or surgery
Patients in radiofrequency ablation group receive circumferential pulmonary vein isolation,and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation. And Cryoablation is performed using a single cryoballoon. The diameter of the cryoballoon is determined as 28 mm or 23 mm according to pulmonary venography results.
| Study group | Role | What they receive |
|---|---|---|
| paroxysmal AF with radiofrequency ablation | Experimental | radiofrequency catheter ablation therapy Receives: Procedure: radiofrequency ablation or cryoballoon |
| persistent AF with radiofrequency ablation group | Experimental | radiofrequency catheter ablation therapy Receives: Procedure: radiofrequency ablation or cryoballoon |
| paroxysmal AF with cryoballoon group | Experimental | cryoballoon ablation therapy Receives: Procedure: radiofrequency ablation or cryoballoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of P wave
Electrocardiogram
Measured: 1-12 month
Atrial effective refractory period
Electrophysiological examination
Measured: During the operation
Secondary outcomes (6)
Plasma biomarkers of inflammation assessed
Blood samples are extracted in all patients for the detection of routine blood, high sensitivity c-reactive protein in mg/L,cystatin C in mg/L.
Measured: 1-12 month
B type natriuretic peptide assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
Left atrial function
Transthoracic echocardiography
Measured: 1-12month
Coagulation index assessed
Blood samples are extracted in all patients to detected
Measured: 1-6 month
homocysteine assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
β2-microglobulin assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Sep 2017
- Primary completion1 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruiqin xie, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322085
- Sponsor's protocol ID
- xierqdoctorER
- Status last verified
- Mar 2020
- First submitted
- 28 Sep 2017
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical Remodeling and the Relationship Between Electrical Remodeling and Structural Remodeling
- ClinicalTrials.gov ID
- NCT03322085
- Acronym / sponsor ID
- xierqdoctorER
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, atrial electrical remodeling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 26 Oct 2017 (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.
This study explored the influence of radiofrequency catheter ablation and cryoballoon ablation on atrial electrical remodeling in patients with atrial fibrillation,the relationship between atrial electrical remodeling and structural remodeling,and which indicators are associated with atrial recurrence after catheter ablation.
Detailed description
From September 2017 to September 2019, the investigators enroll consecutive patients with symptomatic atrial fibrillation (AF) who were scheduled for an initial catheter ablation, including paroxysmal and persistent AF.Patients are divided in to three group: paroxysmal AF in radiofrequency ablation group, persistent AF in radiofrequency ablation group, and paroxysmal AF in Cryoablation group.
- Paroxysmal AF group: The p-wave duration, P wave dispersion and P wave amplitude are detected before and 24 hours after procedure.The atrial effective refractory period, refractory period dispersion, frequency adaptation and atrial conduction time were tested before and after procedure. Detect atrial electromechanical conduction time in the tissue doppler before and 1 week after procedure.
- Persistent AF group: The p-wave duration, P wave dispersion and P wave amplitude are detected 24 hours after procedure.The atrial effective refractory period, refractory period dispersion, frequency adaptation and atrial conduction time were tested after procedure. Detect atrial electromechanical conduction time in the tissue doppler 1 week after procedure.
- Method of detection of atrial electrical remodeling: 1). the measurement of surface electrocardiogram: the p-wave amplitude, P wave time duration and the p-wave duration dispersion (dP =Pmax- Pmin) of the same 12 lead electrocardiogram in the same cardiac cycle.Two cardiologists measured the value separately.The investigators record the mean value. 2). Atrial effective refractory period (AERP) measured from the high right atrium(HRA,the junction of superior vena cava and the right atrium , near the sinus node), low lateral right atrium(LLRA,the junction of inferior vena cava and the right atrium,on the right atrium free wall side), coronary sinus electrode (CS)7.8, and CS1.2 at 3 basic drive cycle lengths (CLs) of 600, 500, and 400 ms. Pacing was performed using a pulse width of 2 ms and a current output of twice the local diastolic threshold. If the latter was 2.0 milliampere (mA), the catheter was replaced and the threshold repeated. AERP was measured using an 8-beat drive train and a single extrastimulus incremented by 10 ms from a starting point of 170 ms. Every AERP was repeated 3 times, and the mean was taken. 3). At each CL, the dispersion of refractoriness was measured by subtracting the minimum from the maximum AERP across the 4 sites.
- Rate adaption of AERP: With the gradual shortening of the pacing cycle lengths, the atrial effective refractory should be shortened accordingly. The rate adaption of AERP was observed in different pacing cycle lengths.
- Atrial conduction time measured at the HRA after 30 seconds of constant pacing at a CL of 600, 500, and 400 ms. Conduction time is measured from the pacing artifact to the onset of the first initial sharp deflection recorded to the first A wave at CS1.10 and CS1.2. Total atrial conduction time=Pace HRA-Acs1.2; Right atrial conduction time=PaceHRA-Acs9.10; Left atrial conduction time=Acs9.10-Acs1.2.6). Atrial electromechanical conduction time: three sampling points are taken at lateral mitral valve(Sa1), septal mitral valve(Sa2), lateral tricuspid valve (Sa3), in the tissue doppler four-chamber view. Atrial electromechanical conduction time is measured from electrocardiogram P wave initiation to ultrasound A wave initiation. Total atrial electromechanical conduction time=T1-T3;Right atrial electromechanical conduction time=T2-T3; Light atrial electromechanical conduction time=T2-T1.
All patients fill the follow-up form before procedure. After catheter ablation therapy, all patients invited to come back to the outpatient clinic every week in the first month, and then at 2, 3, 6, 9, and 12 month to follow up. Patients received electrocardiogram and Holter monitor examination if with symptoms of palpitations. Those patients with no symptoms received electrocardiogram every month and Holter monitor examination every 6 months. Recurrence of atrial fibrillation was defined as atrial fibrillation/flutter or atrial tachycardia lasting ≥ 30 seconds 3 months after radiofrequency catheter ablation therapy. Patients who have AF recurrence within three months after therapy will not be considered for repeated radiofrequency ablation.Blood samples (routine blood, high sensitivity c-reactive protein,B-type natriuretic peptide (BNP), cystatin C,homocysteine,β2-microglobulin) and transthoracic echocardiography indexes (left atrial anterior to posterior diameter, left atrial length-diameter,left atrial transverse-diameter,left atrial volume index, mitral e', E peak, A peak, E/A,velocity time integral (VTI), left atrial ejection fraction, left atrial strain, strain rate and atrial electrical - mechanical conduction time) are recorded in all patients at each follow-up. Patients with AF recurrence must have an electrocardiogram or a 24 hour holter monitor evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| paroxysmal AF with radiofrequency ablation | Experimental | Procedure: radiofrequency ablation or cryoballoonradiofrequency catheter ablation therapy |
| persistent AF with radiofrequency ablation group | Experimental | Procedure: radiofrequency ablation or cryoballoonradiofrequency catheter ablation therapy |
| paroxysmal AF with cryoballoon group | Experimental | Procedure: radiofrequency ablation or cryoballooncryoballoon ablation therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- paroxysmal AF episode occurs in the patient at least twice within half a year (electrocardiogram data or Holter), AF cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is ≤80 years.
Key exclusion criteria (1 listed)
- patients with previous history of AF ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation), left atrium (LA) >50 mm, patients who underwent prosthetic heart valve replacement, pregnant women, patients with existing liver and kidney disease, malignant tumors or hematological system diseases.
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 |
|---|---|---|
| radiofrequency ablation or cryoballoonPatients in radiofrequency ablation group receive circumferential pulmonary vein isolation,and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation. And Cryoablation is performed using a single cryoballoon. The diameter of the cryoballoon is determined as 28 mm or 23 mm according to pulmonary venography results. | Procedure or surgery | paroxysmal AF with cryoballoon group, paroxysmal AF with radiofrequency ablation, persistent AF with radiofrequency ablation group |
Primary outcome
Change of P wave
Time frame: 1-12 month
Electrocardiogram
Atrial effective refractory period
Time frame: During the operation
Electrophysiological examination
6 secondary outcomes
Plasma biomarkers of inflammation assessed
Time frame: 1-12 month
B type natriuretic peptide assessed
Time frame: 1-12 month
Left atrial function
Time frame: 1-12month
Coagulation index assessed
Time frame: 1-6 month
homocysteine assessed
Time frame: 1-12 month
β2-microglobulin assessed
Time frame: 1-12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
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Atrial Fibrillation (AF)
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?
A study testing radiofrequency ablation or cryoballoon in people with Atrial Fibrillation, run by The Second Hospital of Hebei 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of P wave (time frame: 1-12 month). The study lists 2 primary outcomes in all. 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 18 Mar 2021.