- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03564925
Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation (WACACF vs Cryo)
Comparison of Wide Area Circumferential Ablation With Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: YANPING XU, MD
- Phone Number: +86-23-63693079
Study Locations
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Chongqing
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Chongqing, Chongqing, China, 400010
- The Second Affilliated Hospital of Chongqing Medical University
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Sub-Investigator:
- WEIJIE CHEN, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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).
- ≥ 18 and ≤ 75 years of age.
- Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
- 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
- Patients with prosthetic valves.
- Any previous LA ablation or surgery.
- Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment.
- Unstable angina pectoris.
- Myocardial infarction within three months prior to enrollment.
- Symptomatic carotid stenosis.
- Chronic obstructive pulmonary disease with detected pulmonary hypertension.
- Any condition contraindicating chronic anticoagulation.
- Stroke or transient ischemic attack within six months prior to enrollment.
- Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
- New York Heart Association (NYHA) class III or IV congestive heart failure.
- EF < 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history).
- Anteroposterior LA diameter > 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment).
- LA thrombus (TEE diagnostic performed on admission). Intracardiac thrombus.
- PV diameter > 26 mm in right sided PVs.
- Mitral prosthesis.
- Hypertrophic cardiomyopathy
- 2° (Type II) or 3° atrioventricular block.
- Brugada syndrome or long QT syndrome.
- Arrhythmogenic right ventricular dysplasia.
- Sarcoidosis.
- PV stent.
- Myxoma.
Exclusion criteria based on laboratory abnormalities
- Thrombocytosis (platelet count > 600,000 / µl), thrombocytopenia (platelet count < 100,000 / µl).
- Any untreated or uncontrolled hyperthyroidism or hypothyroidism.
- Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) < 15 ml / min).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all-cause death
Time Frame: 12 months
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all-cause death
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12 months
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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
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12 months
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Arrhythmia-related death
Time Frame: 12 months
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Arrhythmia-related death
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12 months
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total procedural duration
Time Frame: 12 months
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time of total procedural
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12 months
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total time of fluoroscopy
Time Frame: 12 months
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total time of fluoroscopy
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12 months
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time to recurrent atrial fibrillation (AF)
Time Frame: 12 months
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a blanking period of three months will be maintained after the initial procedure
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12 months
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time to first cardiovascular hospitalization
Time Frame: 12 months
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a blanking period of three months will be maintained after the initial procedure
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12 months
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number of cardiovascular hospitalizations (over-night stays)
Time Frame: 12 months
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a blanking period of three months will be maintained after the initial procedure
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12 months
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quality of life changes at 12 months compared to baseline
Time Frame: 12 months
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with the evaluation of the MOS item short from health survey(SF-36)
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12 months
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time to first symptomatic AF recurrence
Time Frame: 12 months
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a blanking period of three months will be maintained after the initial procedure
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12 months
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WACACF vs Cryo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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