Atrial FibrillationNCT02074566
Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
A study testing Cryoballoon ablation in people with Atrial Fibrillation, run by Harald Verheij at 2 sites in Netherlands.
Trial summary
Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Cryoballoon ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesNetherlands
- Study dates
- 14 Aug 2014to 13 Feb 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
- Age < 70 years.
- Willing and able to sign informed consent.
- Willing to and capable of following the requested study procedures.
Who cannot join
- Age < 18 years.
- Pregnancy
- Life or follow-up expectancy < 12 months.
- Previous PVI.
- Contrast allergy.
- Creatin clearance level < 60.
- Left ventricular ejection fraction < 40%
- Abnormal left atrium anatomy defined as number of PV's ≠ 4 or Left Atrium diameter >50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or >40 cc/m2 . This will lead to exclusion after inclusion but before randomisation.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medisch Spectrum Twente
Enschede, Nederland, 7500 KA
Maastricht University Medical Centre
Maastricht, 6229 HX
About this study
Official title: A Prospective Randomized Multicentre Efficacy Study on Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Read the detailed description
Rationale Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.
Objective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Study design The study is designed as a prospective multicentre randomized efficacy study.
Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".
Main study parameters/endpoints Acute success of pulmonary vein isolation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
No additional risk is present as the procedure is common clinical practice, current cryoballoon application time is 3 minutes Shorter application times are not expected to add to the risk.
- Conditions
- Atrial Fibrillation
- Being tested
- Cryoballoon ablation
- Keywords
- Pulmonary Vein Isolation, Atrial fibrillation, Cryoballoon therapy, Duration
- 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 ablationOther
PVI using cryoballoon
| Study group | Role | What they receive |
|---|---|---|
| 2 times 1 | Other | PVI will be performed using a cryoballoon ablation application time of 2 times 1 minute Receives: Other: Cryoballoon ablation |
| 2 times 2 | Other | PVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes Receives: Other: Cryoballoon ablation |
| 2 times 3 | Other | PVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes Receives: Other: Cryoballoon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients wit successfull pulmonary vein isolation
Assessment of successfull pulmonary vein isolation after 2 x 1/2/3 minutes of cryoballoon application. The assessment of this outcome will take place during the procedure.
Measured: up to 6 minutes
Secondary outcomes (7)
Number of complications
Complications being:
- Phrenic nerve palsy or diminishment of diaphragm excursion during cryo-ablation.
- Temperatures reaching <12 C in the oesophagus during cryoablation.
- Other complications such as delayed gastric emptying, pericardial fluid/tamponade, haemoptoe, vascular complications.
Measured: 1 year
Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present
The assessment of this outcome will take place during the procedure
Measured: up to 6 minutes
Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation
The assessment of this outcome will take place during the procedure.
Measured: up to 6 minutes
Procedure time, fluoroscopy time, amount of contrast used
The assessment of this outcome will take place right after the procedure. It measures procedural parameters.
Measured: up to 6 minutes
Lower Esophageal Temperature development
The measurement will take place during the procedure. It registrates the lower esophageal temperature ande the development during the course of the procedure.
Measured: up to 6 minutes
Atrial Fibrillation recurrence
Measured: after 1 year follow up
Balloon temperatures measured by the console
Measured: up to 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study start14 Aug 2014
- Primary completion8 Mar 2018
- Study completion13 Feb 2019
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harald Verheij
- Sponsor type
- University, hospital or other
- Collaborators
- Thorax Centrum Twente, Academisch Ziekenhuis Maastricht
- Responsible party
- Sponsor-investigator, Harald Verheij, Thorax Centrum Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074566
- Sponsor's protocol ID
- NL47337.044.13
- Status last verified
- Apr 2019
- First submitted
- 10 Feb 2014
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Multicentre Efficacy Study on Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
- ClinicalTrials.gov ID
- NCT02074566
- Acronym / sponsor ID
- NL47337.044.13
- Conditions
- Atrial Fibrillation
- Keywords
- Pulmonary Vein Isolation, Atrial fibrillation, Cryoballoon therapy, Duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Harald VerheijUniversity, hospital or other
- Collaborators
- Thorax Centrum Twente, Academisch Ziekenhuis Maastricht
- Study start
- 14 Aug 2014 (actual)
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 13 Feb 2019 (actual)
- First posted
- 28 Feb 2014 (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.
Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.The objective of the study is to assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Detailed description
Rationale Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique and its increased effectiveness, the risk of complications increases. Therefore it is of utmost importance to define the optimal duration of cryoballoon ablation time.
Objective To assess the optimal ablation duration using the second generation cryoballoon for isolation of pulmonary veins in the treatment of atrial fibrillation.
Study design The study is designed as a prospective multicentre randomized efficacy study.
Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon ablation after reaching the temperature "plateau phase".
Main study parameters/endpoints Acute success of pulmonary vein isolation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
No additional risk is present as the procedure is common clinical practice, current cryoballoon application time is 3 minutes Shorter application times are not expected to add to the risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 times 1 | Other | Other: Cryoballoon ablationPVI will be performed using a cryoballoon ablation application time of 2 times 1 minute |
| 2 times 2 | Other | Other: Cryoballoon ablationPVI will be performed using a cryoballoon ablation application time of 2 times 2 minutes |
| 2 times 3 | Other | Other: Cryoballoon ablationPVI will be performed using a cryoballoon ablation application time of 2 times 3 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
- Age < 70 years.
- Willing and able to sign informed consent.
- Willing to and capable of following the requested study procedures.
Key exclusion criteria (8 listed)
- Age < 18 years.
- Pregnancy
- Life or follow-up expectancy < 12 months.
- Previous PVI.
- Contrast allergy.
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 ablationPVI using cryoballoon | Other | 2 times 1, 2 times 2, 2 times 3 |
Primary outcome
Number of patients wit successfull pulmonary vein isolation
Time frame: up to 6 minutes
Assessment of successfull pulmonary vein isolation after 2 x 1/2/3 minutes of cryoballoon application. The assessment of this outcome will take place during the procedure.
7 secondary outcomes
Number of complications
Time frame: 1 year
Patients in which acute success of pulmonary vein isolation (after 1 freezing cycle) was present
Time frame: up to 6 minutes
Duration of thaw phase (= time between end of freezing to automatic deflation of the balloon) related to acute success of pulmonary vein isolation
Time frame: up to 6 minutes
Procedure time, fluoroscopy time, amount of contrast used
Time frame: up to 6 minutes
Lower Esophageal Temperature development
Time frame: up to 6 minutes
Atrial Fibrillation recurrence
Time frame: after 1 year follow up
Balloon temperatures measured by the console
Time frame: up to 6 minutes
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 12 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon ablation in people with Atrial Fibrillation, run by Harald Verheij at 2 sites 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 4 inclusion and 8 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 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Number of patients wit successfull pulmonary vein isolation (time frame: up to 6 minutes). 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 12 Mar 2020.