Atrial FibrillationWACACF vs CryoNCT03564925
Wide Area Circumferential Ablation With Contact Force Versus Cryoballoon Ablation
A study testing Wide area circumferential ablation and Cryoballoon ablation in people with Atrial Fibrillation and CryoAblation, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, CryoAblation, Pulmonary Vein Isolation
- What is being tested?
- Wide area circumferential ablation and Cryoballoon ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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).
Trial locations and contacts
1 site in 1 country.
YANPING XU, MD contact
China1 site
The Second Affilliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
ZHIYU LING, MD, +8613512362075, lingzy1977@163.com
YANPING XU, MD, +8613618273302, yxu2013@163.com
About this study
Official title: Comparison of Wide Area Circumferential Ablation With Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
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.
Read the 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.
- Conditions
- Atrial Fibrillation, CryoAblation, Pulmonary Vein Isolation
- Being tested
- Wide area circumferential ablation, Cryoballoon ablation
- Keywords
- Atrial Fibrillation, CryoAblation, pulmonary vein isolation, wide area circumferential ablation, contact force
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wide area circumferential ablationProcedure or surgery
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
Cryoballoon ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Wide area circumferential ablation | Active comparator | 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. Receives: Procedure: Wide area circumferential ablation |
| Cryoballoon ablation | Experimental | 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. Receives: Procedure: Cryoballoon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first documented recurrence of atrial arrhythmias
a blanking period of three months will be maintained after the initial procedure
Measured: 12 months
Secondary outcomes (10)
time to the first occurrence of each of the components of the primary outcome
a blanking period of three months will be maintained after the initial procedure
Measured: 12 months
all-cause death
all-cause death
Measured: 12 months
Arrhythmia-related death
Arrhythmia-related death
Measured: 12 months
total procedural duration
time of total procedural
Measured: 12 months
total time of fluoroscopy
total time of fluoroscopy
Measured: 12 months
time to recurrent atrial fibrillation (AF)
a blanking period of three months will be maintained after the initial procedure
Measured: 12 months
time to first cardiovascular hospitalization
a blanking period of three months will be maintained after the initial procedure
Measured: 12 months
number of cardiovascular hospitalizations (over-night stays)
a blanking period of three months will be maintained after the initial procedure
Measured: 12 months
quality of life changes at 12 months compared to baseline
with the evaluation of the MOS item short from health survey（SF-36）
Measured: 12 months
time to first symptomatic AF recurrence
a blanking period of three months will be maintained after the initial procedure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Jun 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564925
- Sponsor's protocol ID
- WACACF vs Cryo
- Acronym
- WACACF vs Cryo
- Status last verified
- Mar 2019
- First submitted
- 10 Sep 2017
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
PubMed 27042964
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Wide Area Circumferential Ablation With Cryoballoon Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03564925
- Acronym / sponsor ID
- WACACF vs Cryo / WACACF vs Cryo
- Conditions
- Atrial Fibrillation, CryoAblation, Pulmonary Vein Isolation
- Keywords
- Atrial Fibrillation, CryoAblation, pulmonary vein isolation, wide area circumferential ablation, contact force
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two groups, group one is for Wide Area Circumferential Ablation With Contact Force catheter, group two is for Cryoballoon Ablation
| Arm | Type | Receives |
|---|---|---|
| Wide area circumferential ablation | Active comparator | Procedure: Wide area circumferential ablationDevice: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. |
| Cryoballoon ablation | Experimental | Procedure: Cryoballoon ablationDevice: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wide area circumferential ablationWide 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 | Procedure or surgery | Wide area circumferential ablation |
| Cryoballoon ablationIn 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. | Procedure or surgery | Cryoballoon ablation |
Primary outcome
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
10 secondary outcomes
time to the first occurrence of each of the components of the primary outcome
Time frame: 12 months
all-cause death
Time frame: 12 months
Arrhythmia-related death
Time frame: 12 months
total procedural duration
Time frame: 12 months
total time of fluoroscopy
Time frame: 12 months
time to recurrent atrial fibrillation (AF)
Time frame: 12 months
time to first cardiovascular hospitalization
Time frame: 12 months
number of cardiovascular hospitalizations (over-night stays)
Time frame: 12 months
quality of life changes at 12 months compared to baseline
Time frame: 12 months
time to first symptomatic AF recurrence
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 27042964Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YANPING XU, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wide area circumferential ablation and Cryoballoon ablation in people with Atrial Fibrillation and CryoAblation, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZHIYU LING, MD (+8613512362075, lingzy1977@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first documented recurrence of atrial arrhythmias (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.