Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation (WACACF vs Cryo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564925
Recruitment Status : Not yet recruiting
First Posted : June 21, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University

Brief Summary:
The purpose of this randomized clinical trial is to compare the efficacy and safety of wide area circumferential ablation using contact force catheter with cryoballoon ablation for the treatment of paroxysmal atrial fibrillation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation CryoAblation Pulmonary Vein Isolation Procedure: Wide area circumferential ablation Procedure: Cryoballoon ablation Not Applicable

Detailed Description:
Atrial fibrillation (AF) is the most common cardiac arrhythmia and is associated with stroke, reductions in quality of life and overall survival. Previous studies have shown that cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation. However, the pulmonary vein isolation for radiofrequency catheter ablation in previous studies was done around each pulmonary-vein antrum, and it's not wide area circumferential ablation. Moreover, the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing was not performed in most of previous studies. We hypothesize that wide area circumferential ablation with contact force catheter and combined catheter ablation the potential atrial triggers and/or other atrial arrhythmias induced by aggressive induction is more effective than cryoballoon ablation in patients with paroxysmal atrial fibrillation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two groups, group one is for Wide Area Circumferential Ablation With Contact Force catheter, group two is for Cryoballoon Ablation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Wide Area Circumferential Ablation With Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Wide area circumferential ablation
Device:Smart Touch® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
Procedure: Wide area circumferential ablation
Wide area circumferential ablation with contact force catheter will be performed in Patients allocated in this group,the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing will be performed. If frequent atrial premature beats are found beyond pulmonary vein, activation mapping will be performed for eliminating the triggers. If atrial tachycardias(ATs)are induced, activation mapping the ATs and ablation will be performed. Electrical isolation of pulmonary veins and elimination the triggers and ATs induced by isoproterenol or programmed stimulation and burst pacing are the endpoints of ablation

Experimental: Cryoballoon ablation
Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
Procedure: Cryoballoon ablation
In the cryoballoon procedures, pulmonary vein isolation (PVI) was achieved using fluoroscopic guidance to position the cryoballoon catheter. Once PV-to-balloon occlusion was confirmed by retrograde radiopaque contrast agent retention, circumferential ablation was performed by freezing with a single-shot delivery of coolant to the balloon.




Primary Outcome Measures :
  1. Time to first documented recurrence of atrial arrhythmias [ Time Frame: 12 months ]
    a blanking period of three months will be maintained after the initial procedure


Secondary Outcome Measures :
  1. time to the first occurrence of each of the components of the primary outcome [ Time Frame: 12 months ]
    a blanking period of three months will be maintained after the initial procedure

  2. all-cause death [ Time Frame: 12 months ]
    all-cause death

  3. Arrhythmia-related death [ Time Frame: 12 months ]
    Arrhythmia-related death

  4. total procedural duration [ Time Frame: 12 months ]
    time of total procedural

  5. total time of fluoroscopy [ Time Frame: 12 months ]
    total time of fluoroscopy

  6. time to recurrent atrial fibrillation (AF) [ Time Frame: 12 months ]
    a blanking period of three months will be maintained after the initial procedure

  7. time to first cardiovascular hospitalization [ Time Frame: 12 months ]
    a blanking period of three months will be maintained after the initial procedure

  8. number of cardiovascular hospitalizations (over-night stays) [ Time Frame: 12 months ]
    a blanking period of three months will be maintained after the initial procedure

  9. quality of life changes at 12 months compared to baseline [ Time Frame: 12 months ]
    with the evaluation of the MOS item short from health survey(SF-36)

  10. time to first symptomatic AF recurrence [ Time Frame: 12 months ]
    a blanking period of three months will be maintained after the initial procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Symptomatic PAF with at least two episodes and at least one episode documented (30 seconds episode length, documented by ECG within last 12 months).

    Documented treatment failure for effectiveness of at least one anti-arrhythmic drug(AAD Type I or III, including β-blocker and AAD intolerance).

  2. ≥ 18 and ≤ 75 years of age.
  3. Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
  4. Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard RF ablation technique. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. All the details have been presented to him and he has signed the informed consent form for the trial.

Exclusion Criteria:

Exclusion criteria related to a cardiac condition

  1. Patients with prosthetic valves.
  2. Any previous LA ablation or surgery.
  3. Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment.
  4. Unstable angina pectoris.
  5. Myocardial infarction within three months prior to enrollment.
  6. Symptomatic carotid stenosis.
  7. Chronic obstructive pulmonary disease with detected pulmonary hypertension.
  8. Any condition contraindicating chronic anticoagulation.
  9. Stroke or transient ischemic attack within six months prior to enrollment.
  10. Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
  11. New York Heart Association (NYHA) class III or IV congestive heart failure.
  12. EF < 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history).
  13. Anteroposterior LA diameter > 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment).
  14. LA thrombus (TEE diagnostic performed on admission). Intracardiac thrombus.
  15. PV diameter > 26 mm in right sided PVs.
  16. Mitral prosthesis.
  17. Hypertrophic cardiomyopathy
  18. 2° (Type II) or 3° atrioventricular block.
  19. Brugada syndrome or long QT syndrome.
  20. Arrhythmogenic right ventricular dysplasia.
  21. Sarcoidosis.
  22. PV stent.
  23. Myxoma.

Exclusion criteria based on laboratory abnormalities

  1. Thrombocytosis (platelet count > 600,000 / µl), thrombocytopenia (platelet count < 100,000 / µl).
  2. Any untreated or uncontrolled hyperthyroidism or hypothyroidism.
  3. Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min).

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): NCT03564925


Contacts
Layout table for location contacts
Contact: ZHIYU LING, MD +8613512362075 lingzy1977@163.com
Contact: YANPING XU, MD +86-23-63693079

Locations
Layout table for location information
China, Chongqing
The Second Affilliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400010
Contact: ZHIYU LING, MD    +8613512362075    lingzy1977@163.com   
Contact: YANPING XU, MD    +8613618273302    yxu2013@163.com   
Sub-Investigator: WEIJIE CHEN, MD         
Sponsors and Collaborators
The Second Affiliated Hospital of Chongqing Medical University
Publications of Results:
Layout table for additonal information
Responsible Party: Yuehui Yin, Proffessor, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT03564925    
Other Study ID Numbers: WACACF vs Cryo
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University:
Atrial Fibrillation
CryoAblation
pulmonary vein isolation
wide area circumferential ablation
contact force
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes