Persistent Atrial FibrillationNCT03443232
Effect of Catheter Ablation on Left Atrial Function in Persistent Atrial Fibrillation
A study testing Cryoballoon ablation and Radiofrequency ablation in people with Persistent Atrial Fibrillation, run by The Second Hospital of Hebei Medical University at 1 site in China.
Trial summary
A total of 106 patients with drug-refractory persistent atrial fibrillation, who are planned to undergo circumferential pulmonary vein isolation (CPVI), will be randomly allocated into two groups. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Cryoballoon ablation and Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2018to 17 Mar 2020
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persistent AF is defined as AF that persists without interruption for 7 days (electrocardiogram data or Holter), atrial fibrillation cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is <80 years.
Who cannot join
- •left ventricular dysfunction
- atrial thrombosis
- valvular heart disease
- hyperthyroidism
- patients who underwent prosthetic heart valve replacement
- patients with previous history of atrial fibrillation ablation
Show all 10Show fewer
- pregnant women
- patients with existing liver and kidney disease
- malignant tumors
- 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 Effect of Cryoballoon and Radiofrequency Ablations on Left Atrial Structural and Electrical Remodeling in Patients With Drug-refractory Persistent Atrial Fibrillation
A total of 106 patients with drug-refractory persistent atrial fibrillation, who are planned to undergo circumferential pulmonary vein isolation (CPVI), will be randomly allocated into two groups. These patients will receive cryoballoon ablation, radiofrequency ablation under the guidance of 3D mapping respectively (allocation ratio, 1:1). Atrial electrical activity including atrial effective refractory period, atrial conduction time, electromechanical conduction time, P wave dispersion and spatial dispersion of atrial refractory will be measured before and after the operation. Left atrial appendage flow velocity of all patients are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of left atrial function are carried out for all patients before the operation and after the operation. Blood samples are extracted in all patients before the operation and after the operation.This study will clarify whether these different operation methods have different effects on the recovery of postoperative left atrial function and electrical activity in patients with persistent atrial fibrillation, and whether changes in left atrial function electrical activity are related to indicators such as inflammation, blood clotting and myocardial injury. Cryoballoons ablation is still less used to operate on persistent atrial fibrillation. To investigate the ablative effect, electrical remodeling and structural remodeling of persist atrial fibrillation with different operating methods. Therefore, the ablation is related indicators such as the success rate of the operation, intraoperative complications, postoperative recurrence rate and the amount of x-ray exposure are compared among two groups. At the same time, biochemical indicators of inflammation, blood clotting and myocardial injury such as blood routine, myocardial enzyme, BNP, troponin I and D-D dimmer are detected to analyze and determine which indicators are related to the postoperative recurrence of atrial fibrillation, the recovery of postoperative left atrial function.
Read the detailed description
From February 2018 to February 2020, the investigators enroll consecutive patients with drug-refractory persistent atrial fibrillation who were scheduled for an initial catheter ablation.Patients are divided in to two group: persistent AF in radiofrequency ablation group, cryoballoon ablation group.
- Radiofrequency ablation group: Each patient randomly allocated into the radiofrequency ablation group receives circumferential pulmonary vein isolation(CPVI), if atrial flutter is diagnosed before and during operation,then a radiofrequency is used to ablate cavo-tricuspid isthmus. Under the 3D electro-anatomical mapping system (Carto 3, Biosense Webster), after passing through the transseptal sheath, the ablation catheter is infused under pressure to enter into the left atrium to carry out radiofrequency ablation.The default strategy is to create a circle surrounding the two ipsilateral pulmonary veins. The cardioversion is performed if spontaneous conversion is not observed after CPVI. Observation is carried out for 20-30 minutes after the entrance and exit block of pulmonary vein potentials,in the meantime investigators will mapping the left atrial substrate. If mapping system detect a poor substrate,the investigators should continue to ablate for left atrial roof and posterior line.The situation of pulmonary vein potential conduction will be detected again. If there is a recovery, ablation will be continuously carried out.
- Cryoballoon ablation group: Cryoablation is performed using a single cryoballoon. The diameter of the cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter; Medtronic, Minneapolis, MN) is determined as 28 mm or 23 mm according to pulmonary venography results. After passing through the transseptal sheath, the cryoballoon catheter enters into the left atrium and is continuously infused with heparin saline through a 15F oriented sheath. The balloon is inflated at the entrance of the pulmonary vein. The mapping confirms that the balloon blocks the entrance of the pulmonary vein. After blocking of the entrance of the pulmonary vein is enhanced, liquid nitrogen is injected for cryoablation. Before performing right pulmonary vein ablation, a secondary catheter is placed into the superior vena cava during the cryoablation. A cycle length of 999 ms is taken to continuously make the right phrenic nerve pulsate. If diaphragm movement is weakened or disappears, the cryoablation will be immediately stopped. In general, the cryoablation of each pulmonary vein is carried out twice. According to the objective condition, the operator determine whether or not to carry out an additional cryoablation. The cardioversion is performed if spontaneous conversion is not observed after CPVI. Then investigators will applicate electrophysiological substrate mapping for guiding ablation of atrial fibrillation,If mapping system detect a poor substrate, investigators should continue to ablate for left atrial roof and posterior line. By testing the entrance and exit block of pulmonary vein potentials,the investigators observe the duration of potentials.
- All patients fill the follow-up form before operation. 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 ablation therapy. Atrial electrical activity including atrial effective refractory period, atrial conduction time, electromechanical conduction time, P wave dispersion and spatial dispersion of atrial refractory will be measured before and after the operation.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
- Persistent Atrial Fibrillation
- Being tested
- Cryoballoon ablation, Radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon ablationProcedure or surgery
Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice. According to the objective condition, the operator determine whether or not to carry out an additional cryoablation. Then we will applicate electrophysiological substrate mapping for guiding ablation of atrial fibrillation,If mapping system detect a poor substrate,we should continue to ablate for left atrial roof and posterior line.
Radiofrequency ablationProcedure or surgery
Each patient randomly allocated into the radiofrequency ablation group receives circumferential pulmonary vein isolation(CPVI),The default strategy is to create a circle surrounding the two ipsilateral pulmonary veins.We will mapping the left atrial subtrate. If mapping system detect a poor substrate,we should continue to ablate for left atrial roof and posterior line.
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon ablation group | Experimental | Persistens atrial fibrillation in Cryoballoon ablation group will apply cryoablation Receives: Procedure: Cryoballoon ablation |
| Radiofrequency ablation group | Other | Persistens atrial fibrillation in Radiofrequency ablation group will apply Radiofrequency ablation Receives: Procedure: Radiofrequency ablation |
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 electrical activity
Electrophysiological examination
Measured: During the operation
Left atrial function of postoperative
Transthoracic echocardiography
Measured: 1-12 month
Secondary outcomes (3)
Plasma biomarkers of inflammation assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
B type natriuretic peptide assessed
Blood samples are extracted in all patients to detected
Measured: 1-12 month
Coagulation index assessed
Blood samples are extracted in all patients to detected
Measured: 1-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start16 Feb 2018
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xieruiqin, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443232
- Sponsor's protocol ID
- xierqdoctorAF
- Status last verified
- Mar 2020
- First submitted
- 7 Feb 2018
- Last updated
- 18 Mar 2020
- 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 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cryoballoon and Radiofrequency Ablations on Left Atrial Structural and Electrical Remodeling in Patients With Drug-refractory Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03443232
- Acronym / sponsor ID
- xierqdoctorAF
- Conditions
- Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- The Second Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 23 Feb 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.
A total of 106 patients with drug-refractory persistent atrial fibrillation, who are planned to undergo circumferential pulmonary vein isolation (CPVI), will be randomly allocated into two groups. These patients will receive cryoballoon ablation, radiofrequency ablation under the guidance of 3D mapping respectively (allocation ratio, 1:1). Atrial electrical activity including atrial effective refractory period, atrial conduction time, electromechanical conduction time, P wave dispersion and spatial dispersion of atrial refractory will be measured before and after the operation. Left atrial appendage flow velocity of all patients are measured by Transesophageal Echocardiography(TEE) 24 hours before the operation. Real-time ultrasound examinations of left atrial function are carried out for all patients before the operation and after the operation. Blood samples are extracted in all patients before the operation and after the operation.This study will clarify whether these different operation methods have different effects on the recovery of postoperative left atrial function and electrical activity in patients with persistent atrial fibrillation, and whether changes in left atrial function electrical activity are related to indicators such as inflammation, blood clotting and myocardial injury. Cryoballoons ablation is still less used to operate on persistent atrial fibrillation. To investigate the ablative effect, electrical remodeling and structural remodeling of persist atrial fibrillation with different operating methods. Therefore, the ablation is related indicators such as the success rate of the operation, intraoperative complications, postoperative recurrence rate and the amount of x-ray exposure are compared among two groups. At the same time, biochemical indicators of inflammation, blood clotting and myocardial injury such as blood routine, myocardial enzyme, BNP, troponin I and D-D dimmer are detected to analyze and determine which indicators are related to the postoperative recurrence of atrial fibrillation, the recovery of postoperative left atrial function.
Detailed description
From February 2018 to February 2020, the investigators enroll consecutive patients with drug-refractory persistent atrial fibrillation who were scheduled for an initial catheter ablation.Patients are divided in to two group: persistent AF in radiofrequency ablation group, cryoballoon ablation group.
- Radiofrequency ablation group: Each patient randomly allocated into the radiofrequency ablation group receives circumferential pulmonary vein isolation(CPVI), if atrial flutter is diagnosed before and during operation,then a radiofrequency is used to ablate cavo-tricuspid isthmus. Under the 3D electro-anatomical mapping system (Carto 3, Biosense Webster), after passing through the transseptal sheath, the ablation catheter is infused under pressure to enter into the left atrium to carry out radiofrequency ablation.The default strategy is to create a circle surrounding the two ipsilateral pulmonary veins. The cardioversion is performed if spontaneous conversion is not observed after CPVI. Observation is carried out for 20-30 minutes after the entrance and exit block of pulmonary vein potentials,in the meantime investigators will mapping the left atrial substrate. If mapping system detect a poor substrate,the investigators should continue to ablate for left atrial roof and posterior line.The situation of pulmonary vein potential conduction will be detected again. If there is a recovery, ablation will be continuously carried out.
- Cryoballoon ablation group: Cryoablation is performed using a single cryoballoon. The diameter of the cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter; Medtronic, Minneapolis, MN) is determined as 28 mm or 23 mm according to pulmonary venography results. After passing through the transseptal sheath, the cryoballoon catheter enters into the left atrium and is continuously infused with heparin saline through a 15F oriented sheath. The balloon is inflated at the entrance of the pulmonary vein. The mapping confirms that the balloon blocks the entrance of the pulmonary vein. After blocking of the entrance of the pulmonary vein is enhanced, liquid nitrogen is injected for cryoablation. Before performing right pulmonary vein ablation, a secondary catheter is placed into the superior vena cava during the cryoablation. A cycle length of 999 ms is taken to continuously make the right phrenic nerve pulsate. If diaphragm movement is weakened or disappears, the cryoablation will be immediately stopped. In general, the cryoablation of each pulmonary vein is carried out twice. According to the objective condition, the operator determine whether or not to carry out an additional cryoablation. The cardioversion is performed if spontaneous conversion is not observed after CPVI. Then investigators will applicate electrophysiological substrate mapping for guiding ablation of atrial fibrillation,If mapping system detect a poor substrate, investigators should continue to ablate for left atrial roof and posterior line. By testing the entrance and exit block of pulmonary vein potentials,the investigators observe the duration of potentials.
- All patients fill the follow-up form before operation. 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 ablation therapy. Atrial electrical activity including atrial effective refractory period, atrial conduction time, electromechanical conduction time, P wave dispersion and spatial dispersion of atrial refractory will be measured before and after the operation.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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon ablation group | Experimental | Procedure: Cryoballoon ablationPersistens atrial fibrillation in Cryoballoon ablation group will apply cryoablation |
| Radiofrequency ablation group | Other | Procedure: Radiofrequency ablationPersistens atrial fibrillation in Radiofrequency ablation group will apply Radiofrequency ablation |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Persistent AF is defined as AF that persists without interruption for 7 days (electrocardiogram data or Holter), atrial fibrillation cannot be prevented in patients who orally take class I and III antiarrhythmic drugs, and patient age is <80 years.
Key exclusion criteria (10 listed)
- •left ventricular dysfunction
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 |
|---|---|---|
| Cryoballoon ablationCryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice. According to the objective condition, the operator determine whether or not to carry out an additional cryoablation. Then we will applicate electrophysiological substrate mapping for guiding ablation of atrial fibrillation,If mapping system detect a poor substrate,we should continue to ablate for left atrial roof and posterior line. | Procedure or surgery | Cryoballoon ablation group |
| Radiofrequency ablationEach patient randomly allocated into the radiofrequency ablation group receives circumferential pulmonary vein isolation(CPVI),The default strategy is to create a circle surrounding the two ipsilateral pulmonary veins.We will mapping the left atrial subtrate. If mapping system detect a poor substrate,we should continue to ablate for left atrial roof and posterior line. | Procedure or surgery | Radiofrequency ablation group |
Primary outcome
Change of P wave
Time frame: 1-12 month
Electrocardiogram
Atrial electrical activity
Time frame: During the operation
Electrophysiological examination
Left atrial function of postoperative
Time frame: 1-12 month
Transthoracic echocardiography
3 secondary outcomes
Plasma biomarkers of inflammation assessed
Time frame: 1-12 month
B type natriuretic peptide assessed
Time frame: 1-12 month
Coagulation index assessed
Time frame: 1-6 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 2020.
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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?
A study testing Cryoballoon ablation and Radiofrequency ablation in people with Persistent 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 10 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 2020. 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 3 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 2020.