Effect of Catheter Ablation on Left Atrial Function in Persistent Atrial Fibrillation

NCT03443232 | Completed

• 1 other identifier: xierqdoctorAF
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Persistent Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Change of P wave

  Electrocardiogram

  1-12 month

• Atrial electrical activity

  Electrophysiological examination

  During the operation

• Left atrial function of postoperative

  Transthoracic echocardiography

  1-12 month

Secondary Outcomes (3)

• Plasma biomarkers of inflammation assessed

  1-12 month

• B type natriuretic peptide assessed

  1-12 month

• Coagulation index assessed

  1-6 month

Other Outcomes (2)

• homocysteine assessed

  1-12 month

• β2-microglobulin assessed

  1-12 month

Study Arms (2)

Cryoballoon ablation group

EXPERIMENTAL

Persistens atrial fibrillation in Cryoballoon ablation group will apply cryoablation

Procedure: Cryoballoon ablation

Radiofrequency ablation group

OTHER

Persistens atrial fibrillation in Radiofrequency ablation group will apply Radiofrequency ablation

Procedure: Radiofrequency ablation

Interventions

Cryoballoon ablation PROCEDURE

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.

Cryoballoon ablation group

Radiofrequency ablation PROCEDURE

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.

Radiofrequency ablation group

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of cardiology department

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 23, 2018
• Study Start: February 16, 2018
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: March 18, 2020

Record last verified: 2020-03

Locations

CN (1)