Atrial FibrillationPhase 4CRYO-MAPNCT01448265
Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
A Phase 4 study testing Cryoballoon ablation. in people with Atrial Fibrillation, run by Heidelberg University at 1 site in Germany.
Trial summary
Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia, impairs quality of life and increases stroke risk and mortality. Recent clinical experience with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can be used to isolate the pulmonary veins (PVs)… 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.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Jul 2013
- Phase
- Phase 4
- 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
- Documented paroxysmal atrial fibrillation
- ≥18 and ≤75 years of age
- Failure of one or more antiarrhythmic drugs
- Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
Who cannot join
- Previous ablation of atrial fibrillation
- Documented left atrial thrombus
- Irregular pulmonary vein anatomy according to transesophageal echocardiography
- Atrial fibrillation secondary to reversible cause
- Amiodarone therapy in the previous 6 months
- Cardiac surgery within the prior 6 months
Show all 17Show fewer
- Myocardial infarction within the previous 2 months
- Ejection fraction < 40%
- NYHA class III or IV
- Moderate to severe valvular heart disease
- Previous valve replacement
- Pacemaker or implantable cardioverter defibrillator placement in the prior 3 months
- History of stroke or TIA within the previous 12 months
- Left atrial size ≥ 50 mm
- Contraindication for anticoagulation medication
- Life expectancy of less than 12 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Cardiology, University of Heidelberg
Heidelberg, 69120
About this study
Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia, impairs quality of life and increases stroke risk and mortality. Recent clinical experience with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF, thereby eliminating the recurrence of AF.
Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy times decrease with experience.
Read more
Objective: The purpose of this study is to assess safety, feasibility, and a learning curve associated with cryoballoon catheter ablation using a novel circular mapping catheter (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with symptomatic paroxysmal atrial fibrillation.
The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™ mapping catheter. The reduction of procedure and fluoroscopy times during the first 40 patients treated with this approach will be analyzed to evaluate a potential learning curve upon introduction of the technique.
Read the detailed description
A total of 40 patients scheduled for a first ablation of paroxysmal AF will be included. All study subjects will undergo cryoablation using the 28 mm Arctic Front™ Cryoablation Catheter. A double transseptal approach will be followed in all study patients, allowing for use of regular guide wire and circular mapping catheter, respectively, if required.
Use of the 20 mm Achieve™ circular mapping catheter is preferred. The 15 mm AchieveTM catheter may be used at the physician's discretion. If stable balloon positions cannot be obtained, the Achieve™ catheter will be replaced by a regular guide wire and pulmonary vein isolation will be assessed by a circular mapping catheter (Lasso™; Biosense Webster) introduced through a second transseptal puncture. Cryoablations will be applied for 5 minutes each. Premature terminations will be allowed at the physician's discretion but should be avoided to allow for detection of late pulmonary vein isolation during cryoenergy application. Cryoballoon catheter manipulations (e.g., pull down maneuver) may be performed during energy application. During ablation of septal pulmonary veins, electrical phrenic nerve stimulation will be performed to exclude phrenic nerve palsy. If additional single point ablations are required to achieve electrical isolation of pulmonary veins, a linear cryocatheter (Freezor™ Max; Medtronic) will be used.
- Conditions
- Atrial Fibrillation
- Being tested
- Cryoballoon ablation.
- Keywords
- atrial fibrillation, catheter ablation, circular mapping catheter, cryoballoon
- 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 ablation.Procedure or surgery
Cryoballoon ablation using a novel circular mapping catheter.
| Study group | Role | What they receive |
|---|---|---|
| Paroxysmal atrial fibrillation. | Experimental | Not described Receives: Procedure: Cryoballoon ablation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, defined as successful pulmonary vein isolation using the novel circular mapping catheter with the cryoballoon.
Measured: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Secondary outcomes (4)
Time from beginning of the freeze to conduction blockade ("time to effect").
Measured: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Treatment-related adverse events.
Measured: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Procedure time.
Measured: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Overall fluoroscopy time and dose.
Measured: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionJul 2013
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Dierk Thomas, M.D., Heidelberg University
- Investigators
- Dierk Thomas, MD, Principal investigator, Department of Cardiology, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448265
- Sponsor's protocol ID
- CRYO-MAP
- Acronym
- CRYO-MAP
- Status last verified
- Jul 2013
- First submitted
- 30 Sep 2011
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Assessment of Cryoballoon Pulmonary Vein Isolation Using a Novel Circular Mapping Catheter
- ClinicalTrials.gov ID
- NCT01448265
- Acronym / sponsor ID
- CRYO-MAP / CRYO-MAP
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, circular mapping catheter, cryoballoon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 7 Oct 2011 (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.
Background: Atrial fibrillation (AF) is the most frequent sustained cardiac arrhythmia, impairs quality of life and increases stroke risk and mortality. Recent clinical experience with the Arctic Front™ cryoballoon ablation catheter system (Medtronic) suggests that it can be used to isolate the pulmonary veins (PVs) safely and effectively in patients with AF, thereby eliminating the recurrence of AF.
Hypothesis: Our hypotheses are (1) that visualization of real-time pulmonary vein conduction during cryoballoon ablation of atrial fibrillation using a novel spiral circumferential mapping catheter (Achieve™) is feasible and safe, and (2) that procedure and fluoroscopy times decrease with experience.
Objective: The purpose of this study is to assess safety, feasibility, and a learning curve associated with cryoballoon catheter ablation using a novel circular mapping catheter (Achieve™, Medtronic) inserted through the lumen of the cryoballoon in patients with symptomatic paroxysmal atrial fibrillation.
The primary goal is to evaluate successful pulmonary vein isolation using the Achieve™ mapping catheter. The reduction of procedure and fluoroscopy times during the first 40 patients treated with this approach will be analyzed to evaluate a potential learning curve upon introduction of the technique.
Detailed description
A total of 40 patients scheduled for a first ablation of paroxysmal AF will be included. All study subjects will undergo cryoablation using the 28 mm Arctic Front™ Cryoablation Catheter. A double transseptal approach will be followed in all study patients, allowing for use of regular guide wire and circular mapping catheter, respectively, if required.
Use of the 20 mm Achieve™ circular mapping catheter is preferred. The 15 mm AchieveTM catheter may be used at the physician's discretion. If stable balloon positions cannot be obtained, the Achieve™ catheter will be replaced by a regular guide wire and pulmonary vein isolation will be assessed by a circular mapping catheter (Lasso™; Biosense Webster) introduced through a second transseptal puncture. Cryoablations will be applied for 5 minutes each. Premature terminations will be allowed at the physician's discretion but should be avoided to allow for detection of late pulmonary vein isolation during cryoenergy application. Cryoballoon catheter manipulations (e.g., pull down maneuver) may be performed during energy application. During ablation of septal pulmonary veins, electrical phrenic nerve stimulation will be performed to exclude phrenic nerve palsy. If additional single point ablations are required to achieve electrical isolation of pulmonary veins, a linear cryocatheter (Freezor™ Max; Medtronic) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paroxysmal atrial fibrillation. | Experimental | Procedure: Cryoballoon 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)
- Documented paroxysmal atrial fibrillation
- ≥18 and ≤75 years of age
- Failure of one or more antiarrhythmic drugs
- Referral for a pulmonary vein isolation catheter ablation procedure to treat atrial fibrillation
Key exclusion criteria (17 listed)
- Previous ablation of atrial fibrillation
- Documented left atrial thrombus
- Irregular pulmonary vein anatomy according to transesophageal echocardiography
- Atrial fibrillation secondary to reversible cause
- Amiodarone therapy in the previous 6 months
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 ablation.Cryoballoon ablation using a novel circular mapping catheter. | Procedure or surgery | Paroxysmal atrial fibrillation. |
Primary outcome
Feasibility, defined as successful pulmonary vein isolation using the novel circular mapping catheter with the cryoballoon.
Time frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
4 secondary outcomes
Time from beginning of the freeze to conduction blockade ("time to effect").
Time frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Treatment-related adverse events.
Time frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Procedure time.
Time frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
Overall fluoroscopy time and dose.
Time frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.
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 25 Jul 2013.
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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.
Dierk Thomas, MD principal investigator
Department of Cardiology, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cryoballoon ablation. in people with Atrial Fibrillation, run by Heidelberg University at 1 site in Germany.
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 17 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 25 Jul 2013. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility, defined as successful pulmonary vein isolation using the novel circular mapping catheter with the cryoballoon. (time frame: Participants will be followed for the duration of the ablation procedure, an expected average of 1-3 hours.). 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 25 Jul 2013.