- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443232
Effect of Catheter Ablation on Left Atrial Function in Persistent Atrial Fibrillation
March 17, 2020 updated by: xieruiqin, The Second Hospital of Hebei Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050000
- The Second Hospital of Hebei Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 78 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:Persistent
- 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.
Exclusion Criteria:
•left ventricular dysfunction
- atrial thrombosis
- valvular heart disease
- hyperthyroidism
- patients who underwent prosthetic heart valve replacement
- patients with previous history of atrial fibrillation ablation
- pregnant women
- patients with existing liver and kidney disease
- malignant tumors
- hematological system diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryoballoon ablation group
Persistens atrial fibrillation in Cryoballoon ablation group will apply cryoablation
|
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.
|
Other: Radiofrequency ablation group
Persistens atrial fibrillation in Radiofrequency ablation group will apply Radiofrequency ablation
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of P wave
Time Frame: 1-12 month
|
Electrocardiogram
|
1-12 month
|
Atrial electrical activity
Time Frame: During the operation
|
Electrophysiological examination
|
During the operation
|
Left atrial function of postoperative
Time Frame: 1-12 month
|
Transthoracic echocardiography
|
1-12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma biomarkers of inflammation assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
B type natriuretic peptide assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
Coagulation index assessed
Time Frame: 1-6 month
|
Blood samples are extracted in all patients to detected
|
1-6 month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
homocysteine assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
β2-microglobulin assessed
Time Frame: 1-12 month
|
Blood samples are extracted in all patients to detected
|
1-12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 16, 2018
Primary Completion (Actual)
March 17, 2020
Study Completion (Actual)
March 17, 2020
Study Registration Dates
First Submitted
February 7, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
March 18, 2020
Last Update Submitted That Met QC Criteria
March 17, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- xierqdoctorAF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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