Atrial FibrillationCAFENCT06701383
Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation
A study testing Cryoablation in people with Atrial Fibrillation, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial summary
Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use. A new imaging technique (3D CT overlay) could reduce radiation exposure and contrast medium use significantly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cryoablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2012to May 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients screened are accepted for PVI according to the current guidelines - Patients are candidates for enrolment if they have paroxysmal AF as defined in the guidelines
Who cannot join
- Persistent, long-standing persistent or permanent AF
- Left atrial diameter > 50 mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography)
- Previous PVI ablation (epicardial or endocardial).
Trial locations and contacts
1 site in 1 country.
About this study
Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use. A new imaging technique (3D CT overlay) could reduce radiation exposure and contrast medium use significantly.
- Conditions
- Atrial Fibrillation
- Being tested
- Cryoablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Pulmonary vein isolation using cryoablation
| Study group | Role | What they receive |
|---|---|---|
| Standard fluorscopy | Active comparator | Cryoablation using a balloon with standard fluoroscopy Receives: Device: Cryoablation |
| 3D CT overlay | Experimental | Cryoablation using a balloon with 3D CT overlay Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoroscopy time
To compare the fluoroscopy time between cryoballoon ablation with and without the use of 3D CT overlay
Measured: Procedure time
radiation exposure
To compare the radiation exposure (DAP) between cryoballoon ablation with and without the use of 3D CT overlay
Measured: Procedure time
Contrast
To compare the amount of contrast medium between cryoballoon ablation with and without the use of 3D CT overlay
Measured: Amount of contrast during procedure
Secondary outcomes (1)
Recurrence
The percentage of patients without a recurrence of AF, without AADs, within a follow-up period of at least 12 months after a stabilisation period of 90 days after the initial procedure.
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 posted22 Nov 2024
- Study startAug 2012
- Primary completionMay 2014
- Study completionMay 2015
Why it stopped: Safety point reached, subjects in the 3D CT overlay group received sugnificantly less contrast.
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, B. Oude Velthuis, Medisch Spectrum Twente
- Investigators
- Jurren van Opstal, MD, PhD, Principal investigator, Medisch Spectrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701383
- Sponsor's protocol ID
- NL39065.044.11
- Other IDs
- P12-16
- Acronym
- CAFE
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between 3 D CT Overlay and Conventional Fluoroscopy to Decrease Contrast and Radiation Exposure During Cryoballoon Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06701383
- Acronym / sponsor ID
- CAFE / NL39065.044.11
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety point reached, subjects in the 3D CT overlay group received sugnificantly less contrast.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Nov 2024 (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.
Cryoablation using a balloon is an effective therapy for paroxysmal atrial fibrillation (AF), however associated with significant amounts of radiation exposure and contrast medium use. A new imaging technique (3D CT overlay) could reduce radiation exposure and contrast medium use significantly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard fluorscopy | Active comparator | Device: CryoablationCryoablation using a balloon with standard fluoroscopy |
| 3D CT overlay | Experimental | Device: CryoablationCryoablation using a balloon with 3D CT overlay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients screened are accepted for PVI according to the current guidelines - Patients are candidates for enrolment if they have paroxysmal AF as defined in the guidelines
Key exclusion criteria (3 listed)
- Persistent, long-standing persistent or permanent AF
- Left atrial diameter > 50 mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography)
- Previous PVI ablation (epicardial or endocardial).
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 |
|---|---|---|
| CryoablationPulmonary vein isolation using cryoablation | Device | 3D CT overlay, Standard fluorscopy |
Primary outcome
Fluoroscopy time
Time frame: Procedure time
To compare the fluoroscopy time between cryoballoon ablation with and without the use of 3D CT overlay
radiation exposure
Time frame: Procedure time
To compare the radiation exposure (DAP) between cryoballoon ablation with and without the use of 3D CT overlay
Contrast
Time frame: Amount of contrast during procedure
To compare the amount of contrast medium between cryoballoon ablation with and without the use of 3D CT overlay
1 secondary outcome
Recurrence
Time frame: one year
Results and safety
The study was stopped early (reason given: Safety point reached, subjects in the 3D CT overlay group received sugnificantly less contrast.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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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.
Jurren van Opstal, MD, PhD principal investigator
Medisch Spectrum Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Atrial Fibrillation, run by Medisch Spectrum Twente at 1 site in Netherlands.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 22 Nov 2024. 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 Netherlands. 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 was stopped early (reason given: Safety point reached, subjects in the 3D CT overlay group received sugnificantly less contrast.). Results are not available in the source record.
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?
Fluoroscopy time (time frame: Procedure time). The study lists 3 primary outcomes in all. 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 22 Nov 2024; AzTrials last refreshed its copy on 4 Nov 2026.