Atrial FibrillationCRYO-AFNCT03044951
Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）
A study testing cryoballoon ablation and radiofrequency ablation in people with Atrial Fibrillation, run by Ruijin Hospital at 1 site in China.
Trial summary
It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- cryoballoon ablation and radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2020
- 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
- ECG recording of atrial fibrillation
- first time of ablation
- refractory to at least one anti-arrhythmia drug
- sign informed consent for participation in the study
Who cannot join
- had ablation before
- serious heart failure
- left atrial diameter>55mm
- Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation
- Stroke in 6 months before the ablation
- Endocardial thrombosis
Trial locations and contacts
1 site in 1 country.
Qi Jin contact
China1 site, 1 recruiting
- Recruiting
Shanghai Rui-Jin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Li-Qun Wu, wuliqun89@hotmail.com
Tian-You Ling, lty0919@hotmail.com
About this study
Official title: Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.
Read the detailed description
The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.
- Conditions
- Atrial Fibrillation
- Being tested
- cryoballoon ablation, radiofrequency ablation
- Keywords
- atrial fibrillation, cryoablation, irrigated radiofrequency ablation, pulmonary vein isolation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoballoon ablationProcedure or surgery
cryoballoon ablation：pulmonary vein isolation by cryoballoon
radiofrequency ablationProcedure or surgery
radiofrequency ablation: pulmonary vein isolation by radiofrequency energy
| Study group | Role | What they receive |
|---|---|---|
| cryoballoon ablation | Experimental | patients who accept cryoballoon ablation Receives: Procedure: cryoballoon ablation |
| radiofrequency ablation | Active comparator | patients who accept radiofrequency ablation Receives: Procedure: radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint (time to first documented clinical recurrence after blanking period)
the time to first documented clinical recurrence after blanking period (month)
Measured: one year
Safety endpoint (Any procedure-related complications)
Any procedure-related complications
Measured: one year
Secondary outcomes (5)
Procedure time (min)
skin to skin
Measured: one year
Left atrial time (min)
Measured: one year
X-ray time (min)
Measured: one year
time to first time cardiovascular hospitalization (month)
Measured: one year
QoL changes at 12 months (Units on a Scale)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startNov 2016
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Jin, Ruijin Hospital
- Investigators
- Li-Qun Wu, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044951
- Sponsor's protocol ID
- DLY201604
- Acronym
- CRYO-AF
- Status last verified
- Feb 2017
- First submitted
- 30 Jan 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 27042964Andrade JG, Khairy P, Macle L, Packer DL, Lehmann JW, Holcomb RG, Ruskin JN, Dubuc M. Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):69-75. doi: 10.1161/CIRCEP.113.000586. Epub 2014 Jan 19.
PubMed 24446022
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballoon Versus Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: A Multi-center, Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03044951
- Acronym / sponsor ID
- CRYO-AF / DLY201604
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, cryoablation, irrigated radiofrequency ablation, pulmonary vein isolation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- 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.
It's a multi-center, prospective, randomized, controlled clinical trial of cryoballoon versus radiofrequency ablation for paroxysmal atrial fibrillation.
Detailed description
The hypothesis of this study is that pulmonary vein isolation with cryoballoon ablation is not inferior to radiofrequency ablation with 3D mapping with respect to clinical safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cryoballoon ablation | Experimental | Procedure: cryoballoon ablationpatients who accept cryoballoon ablation |
| radiofrequency ablation | Active comparator | Procedure: radiofrequency ablationpatients who accept radiofrequency ablation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ECG recording of atrial fibrillation
- first time of ablation
- refractory to at least one anti-arrhythmia drug
- sign informed consent for participation in the study
Key exclusion criteria (6 listed)
- had ablation before
- serious heart failure
- left atrial diameter>55mm
- Myocardial infarction, heart surgery or coronary intervention in 3 months before the ablation
- Stroke in 6 months before the ablation
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 |
|---|---|---|
| cryoballoon ablationcryoballoon ablation：pulmonary vein isolation by cryoballoon | Procedure or surgery | cryoballoon ablation |
| radiofrequency ablationradiofrequency ablation: pulmonary vein isolation by radiofrequency energy | Procedure or surgery | radiofrequency ablation |
Primary outcome
Efficacy endpoint (time to first documented clinical recurrence after blanking period)
Time frame: one year
the time to first documented clinical recurrence after blanking period (month)
Safety endpoint (Any procedure-related complications)
Time frame: one year
Any procedure-related complications
5 secondary outcomes
Procedure time (min)
Time frame: one year
Left atrial time (min)
Time frame: one year
X-ray time (min)
Time frame: one year
time to first time cardiovascular hospitalization (month)
Time frame: one year
QoL changes at 12 months (Units on a Scale)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- 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.
- Results publication: PubMed 24446022Andrade JG, Khairy P, Macle L, Packer DL, Lehmann JW, Holcomb RG, Ruskin JN, Dubuc M. Incidence and significance of early recurrences of atrial fibrillation after cryoballoon ablation: insights from the multicenter Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial. Circ Arrhythm Electrophysiol. 2014 Feb;7(1):69-75. doi: 10.1161/CIRCEP.113.000586. Epub 2014 Jan 19.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Atrial Fibrillation (AF)
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.
Qi Jin contact
Li-Qun Wu principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoballoon ablation and radiofrequency ablation in people with Atrial Fibrillation, run by Ruijin Hospital 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 4 inclusion and 6 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 7 Feb 2017. 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 Qi Jin (jinqi127@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint (time to first documented clinical recurrence after blanking period) (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT03044951, which also lists 2 linked publications.
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 7 Feb 2017.