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The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical

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ClinicalTrials.gov Identifier: NCT03322085
Recruitment Status : Recruiting
First Posted : October 26, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ruiqin xie, The Second Hospital of Hebei Medical University

Brief 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 ablation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: radiofrequency ablation or cryoballoon Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Catheter Ablation for Atrial Fibrillation on Atrial Electrical Remodeling and the Relationship Between Electrical Remodeling and Structural Remodeling
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: paroxysmal AF with radiofrequency ablation
radiofrequency catheter ablation therapy
Procedure: radiofrequency ablation or cryoballoon
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.

Experimental: persistent AF with radiofrequency ablation group
radiofrequency catheter ablation therapy
Procedure: radiofrequency ablation or cryoballoon
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.

Experimental: paroxysmal AF with cryoballoon group
cryoballoon ablation therapy
Procedure: radiofrequency ablation or cryoballoon
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.




Primary Outcome Measures :
  1. Change of P wave [ Time Frame: 1-12 month ]
    Electrocardiogram

  2. Atrial effective refractory period [ Time Frame: During the operation ]
    Electrophysiological examination


Secondary Outcome Measures :
  1. Plasma biomarkers of inflammation assessed [ Time Frame: 1-12 month ]
    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.

  2. B type natriuretic peptide assessed [ Time Frame: 1-12 month ]
    Blood samples are extracted in all patients to detected

  3. Left atrial function [ Time Frame: 1-12month ]
    Transthoracic echocardiography

  4. Coagulation index assessed [ Time Frame: 1-6 month ]
    Blood samples are extracted in all patients to detected

  5. homocysteine assessed [ Time Frame: 1-12 month ]
    Blood samples are extracted in all patients to detected

  6. β2-microglobulin assessed [ Time Frame: 1-12 month ]
    Blood samples are extracted in all patients to detected



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03322085


Contacts
Contact: ruiqin xie, doctor +8615803212537 13230178060@163.com
Contact: ling you youling349@sina.com

Locations
China, Hebei
The Second Hospital of Hebei Medical University Recruiting
Shijiazhuang, Hebei, China, 050000
Contact: Xieruiqin    15803212537    13230178060@163.com   
Sponsors and Collaborators
The Second Hospital of Hebei Medical University

Responsible Party: Ruiqin xie, director of cardiology department, The Second Hospital of Hebei Medical University
ClinicalTrials.gov Identifier: NCT03322085     History of Changes
Other Study ID Numbers: xierqdoctorER
First Posted: October 26, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ruiqin xie, The Second Hospital of Hebei Medical University:
atrial fibrillation
atrial electrical remodeling

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Remodeling
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Pathological Conditions, Anatomical