Atrial FibrillationSD-CRYO-AFNCT03003975
Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation
A study testing PVI by single cryoballoon application guided by Achieve Mapping Catheter and PVI by 2 routine cryoballoon applications in people with Atrial Fibrillation, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
This is a clinical study where the investigators will assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). 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?
- PVI by single cryoballoon application guided by Achieve Mapping Catheter and PVI by 2 routine cryoballoon applications
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2014to Mar 2017
- 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
- Patients with paroxysmal or persistent AF verified by ECG
- Patients with symptoms corresponding to at least Europe Heart Rhythm Association (EHRA) score 2.
Who cannot join
- Sinus rhythm cannot be maintained for at least one hour after an electrical cardioversion.
- Congestive heart failure with New York Heart Association (NYHA) class 3 or more.
- Left ventricular ejection fraction < 35% not secondary to AF with inadequate rate control, according to the judgement of the investigator.
- Left atrial diameter ≥ 55 mm judged by transthoracic echocardiography.
- Prior AF ablation procedure.
- Longstanding persistent AF
Show all 18Show fewer
- AF secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and uncontrolled thyroid disease as well as AF triggered by other uniform supraventricular tachycardia.
- Contraindication to treatment with anticoagulants.
- Significant valvular disease or planned cardiac intervention.
- Hypertrophic cardiomyopathy.
- Recent cardiac disease states within the last 6 months; unstable angina, acute myocardial infarction, revascularisation procedures, valve disease
- Implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) device.
- Dual chamber- and single chamber-pacemaker when the patient is pacemaker dependent on ventricular level
- Patients with contraindications for transseptal catheterization or appropriate vascular access is precluded.
- Renal failure requiring dialysis or abnormalities of liver function tests.
- Participant in investigational clinical or device trial.
- Unwilling or unable to give informed consent or inaccessible for follow-up and psychological problem that might limit compliance.
- Active abuse of alcohol or other substance which may be causative of AF and/or might affect compliance.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiology, University Hospital in Uppsala
Uppsala, 75185
About this study
Official title: Efficacy of Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation (SD-Cryo-AF): A Randomized Study
This is a clinical study where the investigators will assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).
Read the detailed description
This is a prospective, randomized clinical study performed at one centre. The objective is to assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation in patients with atrial fibrillation (AF).
140 subjects with paroxysmal or persistent atrial fibrillation referred for their first AF ablation procedures will be enrolled.
Recruitment, ablation and follow-up will be performed at Dep of Cardiology in Uppsala University Hospital, Uppsala, Sweden.
Study duration is 2 years with 12--months enrolment period and 1 year follow-up per subject.
Pulmonary vein isolation (PVI) will be performed using the Arctic Front Advance cryoballoon ablation catheter. Patients will be randomized to a single cryoballoon application guided by a multipolar recording catheter or to a conventional technique with 2 cryoballoon applications. After cryoballoon ablation of all pulmonary veins, PV conduction block will be assessed by a separate circular mapping catheter. Acute procedural success is defined as complete electrical isolation of a pulmonary vein assessed by entrance and exit block, including 20 minutes waiting time. Complications and duration of the procedure will be assessed.
Patients will be followed at three, six and 12 months after the ablation procedure. A 12 lead ECG, a 7 day Holter monitoring, quality of life (EQ5D) and EHRA score, will be performed at baseline, 6 and 12 months. as well as Biomarkers including nTproBNP and troponin I, will be performed at baseline, and at 6 and 12 months (only nTproBNP). Predictive variables for successful outcome/AF recurrence will be analysed.
The frequency of symptomatic recurrence of AF and number of reablations will be compared at 6 and 12 months, and in those requiring a redo ablation procedure the status of PV reconduction will be assessed.
- Conditions
- Atrial Fibrillation
- Being tested
- PVI by single cryoballoon application guided by Achieve Mapping Catheter, PVI by 2 routine cryoballoon applications
- Keywords
- Ablation, Cryoballoon, Achieve
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI by single cryoballoon application guided by Achieve Mapping CatheterDevice
Also called Arctic Front™ Advance Cardiac CryoAblation Catheter, Achieve Mapping Catheter
Pulmonary vein isolation by single cryoballoon application guided by recorded electrogram signals from an internal Mapping Catheter and by temperature drop if mapping of signals is not possible (temperature cutoff < or = -40 degrees C)
PVI by 2 routine cryoballoon applicationsDevice
Also called Arctic Front™ Advance Cardiac CryoAblation Catheter
Pulmonary vein isolation by 2 cryoballoon applications guided by degree of occlusion and by temperature drop according to discretion of physician
| Study group | Role | What they receive |
|---|---|---|
| PVI by single cryoballoon application | Active comparator | A single cryoballoon application for pulmonary vein isolation will be guided by a Multipolar Recording Catheter (Achieve Mapping Catheter), passed through the inner lumen of the cryoablation catheter. A single application of 4 minutes will be used per vein guided by recording of loss of electrograms and by a defined drop of temperature within 2 minutes application. If a stable position with adequate occlusion of the vein the Achieve catheter should be located proximally for evaluation of entrance block during application, but can be advanced deeper for stability and then retracted to the ostium to evaluate vein isolation (entrance block).
If the vein then is isolated after a single application, the operator can move on to the next vein. Receives: Device: PVI by single cryoballoon application guided by Achieve Mapping Catheter |
| PVI by 2 cryo applications | Active comparator | Cryoballoon ablation with a conventional guidewire passed through the inner lumen of the catheter for stability will be used. Ablation will be performed with 2 consecutive applications for 4 minutes each in each vein guided by degree of occlusion and temperature drop at the discretion of the physician. Receives: Device: PVI by 2 routine cryoballoon applications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute pulmonary vein isolation after first ablation.
Frequency of complete pulmonary vein isolation after first pass of ablation as per protocol
Measured: Acute during ablation procedure
Secondary outcomes (19)
Procedure time
Procedure time of AF ablation (from initial puncture to removal of sheaths)
Measured: During ablation procedure
Fluoroscopy exposure
Total time of fluoroscopy for AF ablation
Measured: During ablation procedure
Freedom from atrial fibrillation
No atrial fibrillation after first ablation
Measured: Evaluated after 12 months
Adverse/Serious Adverse events
Complications during and after ablation
Measured: Evaluated after 12 months
Quality of Life after ablation
Quality of life assessed by EQ5D after ablation compared to baseline
Measured: Evaluated after 12 months
Reduction of symptom severity score after ablation
Symptoms Severity Questionnaire, score reduction after ablation
Measured: Evaluated after 12 months
Reduction of overall symptoms of atrial fibrillation after ablation
Symptom assessed by EHRA Symptom Classification score reduction after ablation
Measured: Evaluated after 12 months
Cost of ablation procedure
Assessed by time for procedure, used resources and equipment during/after ablation
Measured: Evaluated after initial ablation (within 24 h after ablation)
Quality of life after ablation (measured as EQ5D score)
EQ5D measured before ablation and after 12 months
Measured: Evaluated after 12 months
Hospitalisation after ablation
hospitalisation (no of days)
Measured: Evaluated after 12 months
Maximum troponin I (ng/L) levels after ablation as a predictor of clinical success
Maximum troponin I (ng/L) levels as a predictor of freedom from AF after 12 months
Measured: Evaluated after 12 months
Nt-proBNP levels before ablation as a predictor of clinical success
Nt-proBNP levels as a predictor of freedom from AF after 12 months
Measured: Evaluated after 12 months
Left atrial diameter (mm) before ablation as a predictor of clinical success
Left atrial diameter in mm (LAX view) as a predictor of freedom from AF after 12 months
Measured: Evaluated after 12 months
Left atrial volume (ml/m2) before ablation as a predictor of clinical success
Left atrial volume (ml/m2) as a predictor of freedom from AF after 12 months
Measured: Evaluated after 12 months
Age (years) as a predictor of clinical success
Age at ablation (years) as a predictor of freedom from AF after 12 months; 2 groups; < 70 and >70 years old
Measured: Evaluated after 12 months
Sex as a predictor of clinical success
Sex as a predictor of freedom from AF after 12 months. 2 groups; male vs females
Measured: Evaluated after 12 months
CHADsVASc score as a predictor of clinical success
CHADsVASc score as a predictor of freedom from AF after 12 months
Measured: Evaluated after 12 months
BMI (kg/m2) as a predictor of clinical success
BMI (kg/m2) as a predictor of freedom from AF after 12 months
Measured: Evaluated after 12 months
Atrial conduction time as a predictor of clinical success
Mean conduction time over left atrium as a predictor of freedom from AF after 12 months
Measured: Evaluated after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startNov 2014
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carina Blomstrom Lundqvist, Uppsala University Hospital
- Investigators
- Carina Blomström Lundqvist, Professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003975
- Sponsor's protocol ID
- SD-CRYO-AF
- Acronym
- SD-CRYO-AF
- Status last verified
- May 2017
- First submitted
- 9 Dec 2016
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Single Versus Double Cryoballoon Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation (SD-Cryo-AF): A Randomized Study
- ClinicalTrials.gov ID
- NCT03003975
- Acronym / sponsor ID
- SD-CRYO-AF / SD-CRYO-AF
- Conditions
- Atrial Fibrillation
- Keywords
- Ablation, Cryoballoon, Achieve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Dec 2016 (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.
This is a clinical study where the investigators will assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).
Detailed description
This is a prospective, randomized clinical study performed at one centre. The objective is to assess the efficacy of a single cryoballoon application per vein guided by a multipolar recording catheter as compared with a conventional technique with 2 cryoballoon applications for pulmonary vein isolation in patients with atrial fibrillation (AF).
140 subjects with paroxysmal or persistent atrial fibrillation referred for their first AF ablation procedures will be enrolled.
Recruitment, ablation and follow-up will be performed at Dep of Cardiology in Uppsala University Hospital, Uppsala, Sweden.
Study duration is 2 years with 12--months enrolment period and 1 year follow-up per subject.
Pulmonary vein isolation (PVI) will be performed using the Arctic Front Advance cryoballoon ablation catheter. Patients will be randomized to a single cryoballoon application guided by a multipolar recording catheter or to a conventional technique with 2 cryoballoon applications. After cryoballoon ablation of all pulmonary veins, PV conduction block will be assessed by a separate circular mapping catheter. Acute procedural success is defined as complete electrical isolation of a pulmonary vein assessed by entrance and exit block, including 20 minutes waiting time. Complications and duration of the procedure will be assessed.
Patients will be followed at three, six and 12 months after the ablation procedure. A 12 lead ECG, a 7 day Holter monitoring, quality of life (EQ5D) and EHRA score, will be performed at baseline, 6 and 12 months. as well as Biomarkers including nTproBNP and troponin I, will be performed at baseline, and at 6 and 12 months (only nTproBNP). Predictive variables for successful outcome/AF recurrence will be analysed.
The frequency of symptomatic recurrence of AF and number of reablations will be compared at 6 and 12 months, and in those requiring a redo ablation procedure the status of PV reconduction will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI by single cryoballoon application | Active comparator | Device: PVI by single cryoballoon application guided by Achieve Mapping CatheterA single cryoballoon application for pulmonary vein isolation will be guided by a Multipolar Recording Catheter (Achieve Mapping Catheter), passed through the inner lumen of the cryoablation catheter. A single application of 4 minutes will be used per vein guided by recording of loss of electrograms and by a defined drop of temperature within 2 minutes application. If a stable position with adequate occlusion of the vein the Achieve catheter should be located proximally for evaluation of entrance block during application, but can be advanced deeper for stability and then retracted to the ostium to evaluate vein isolation (entrance block). If the vein then is isolated after a single application, the operator can move on to the next vein. |
| PVI by 2 cryo applications | Active comparator | Device: PVI by 2 routine cryoballoon applicationsCryoballoon ablation with a conventional guidewire passed through the inner lumen of the catheter for stability will be used. Ablation will be performed with 2 consecutive applications for 4 minutes each in each vein guided by degree of occlusion and temperature drop at the discretion of the physician. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with paroxysmal or persistent AF verified by ECG
- Patients with symptoms corresponding to at least Europe Heart Rhythm Association (EHRA) score 2.
Key exclusion criteria (18 listed)
- Sinus rhythm cannot be maintained for at least one hour after an electrical cardioversion.
- Congestive heart failure with New York Heart Association (NYHA) class 3 or more.
- Left ventricular ejection fraction < 35% not secondary to AF with inadequate rate control, according to the judgement of the investigator.
- Left atrial diameter ≥ 55 mm judged by transthoracic echocardiography.
- Prior AF ablation procedure.
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 |
|---|---|---|
| PVI by single cryoballoon application guided by Achieve Mapping CatheterAlso: Arctic Front™ Advance Cardiac CryoAblation Catheter, Achieve Mapping CatheterPulmonary vein isolation by single cryoballoon application guided by recorded electrogram signals from an internal Mapping Catheter and by temperature drop if mapping of signals is not possible (temperature cutoff < or = -40 degrees C) | Device | PVI by single cryoballoon application |
| PVI by 2 routine cryoballoon applicationsAlso: Arctic Front™ Advance Cardiac CryoAblation CatheterPulmonary vein isolation by 2 cryoballoon applications guided by degree of occlusion and by temperature drop according to discretion of physician | Device | PVI by 2 cryo applications |
Primary outcome
Frequency of acute pulmonary vein isolation after first ablation.
Time frame: Acute during ablation procedure
Frequency of complete pulmonary vein isolation after first pass of ablation as per protocol
19 secondary outcomes
Procedure time
Time frame: During ablation procedure
Fluoroscopy exposure
Time frame: During ablation procedure
Freedom from atrial fibrillation
Time frame: Evaluated after 12 months
Adverse/Serious Adverse events
Time frame: Evaluated after 12 months
Quality of Life after ablation
Time frame: Evaluated after 12 months
Reduction of symptom severity score after ablation
Time frame: Evaluated after 12 months
Reduction of overall symptoms of atrial fibrillation after ablation
Time frame: Evaluated after 12 months
Cost of ablation procedure
Time frame: Evaluated after initial ablation (within 24 h after ablation)
Quality of life after ablation (measured as EQ5D score)
Time frame: Evaluated after 12 months
Hospitalisation after ablation
Time frame: Evaluated after 12 months
Maximum troponin I (ng/L) levels after ablation as a predictor of clinical success
Time frame: Evaluated after 12 months
Nt-proBNP levels before ablation as a predictor of clinical success
Time frame: Evaluated after 12 months
Left atrial diameter (mm) before ablation as a predictor of clinical success
Time frame: Evaluated after 12 months
Left atrial volume (ml/m2) before ablation as a predictor of clinical success
Time frame: Evaluated after 12 months
Age (years) as a predictor of clinical success
Time frame: Evaluated after 12 months
Sex as a predictor of clinical success
Time frame: Evaluated after 12 months
CHADsVASc score as a predictor of clinical success
Time frame: Evaluated after 12 months
BMI (kg/m2) as a predictor of clinical success
Time frame: Evaluated after 12 months
Atrial conduction time as a predictor of clinical success
Time frame: Evaluated after 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
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.
Carina Blomström Lundqvist, Professor principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI by single cryoballoon application guided by Achieve Mapping Catheter and PVI by 2 routine cryoballoon applications in people with Atrial Fibrillation, run by Uppsala University Hospital at 1 site in Sweden.
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 2 inclusion and 18 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: finished, as of the sponsor's last update on 9 May 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of acute pulmonary vein isolation after first ablation. (time frame: Acute during ablation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2017; AzTrials last refreshed its copy on 31 Oct 2026.