Atrial FibrillationCANARI-AFNCT03489096
Cryoballoon Targeting Atrial Fibrosis in Atrial Fibrillation
A study testing Cryoballoon Ablation: PVI + substrate modification in people with Atrial Fibrillation and Left Atrial Fibrosis, run by University of Utah.
Trial summary
Pulmonary vein isolation (PVI) using cryoballoon ablation is a well-established procedure for the treatment of atrial fibrillation (AF). However, the use of cryoballoon ablation in recent clinical trials have been limited to PVI. As such, patients with paroxysmal AF have been the main recipients of this procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Left Atrial Fibrosis
- What is being tested?
- Cryoballoon Ablation: PVI + substrate modification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Oct 2021
- 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
- Referred for cryoballoon ablation of paroxysmal or persistent atrial fibrillation
- 18 years of age or older
- Ability to give informed consent in accordance with University of Utah IRB guidelines
Who cannot join
- Previous ablation for atrial fibrillation or atypical atrial flutter
- Contraindication to MRI contrast agent
- Unquantifiable fibrosis or moderate to severe left-atrial fibrosis (≥ 20%)
- Contraindication for chronic anticoagulation therapy
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular disease within the last 2 months
- Implanted cardiac device
Show all 14Show fewer
- Presence of left atrial thrombus
- Contraindications to cryoballoon ablation including history of cryoglobulinemia, active systemic infection, and presence of one or more pulmonary vein stents
- New York Heart Association (NYHA) class IV heart failure
- Women who are currently pregnant or breast feeding or using unreliable contraceptive measures if premenopausal
- Enrollment in another investigational trial
- Untreated hyperthyroidism or hypothyroidism
- Life expectancy < 12 months due to a terminal disease
- Presence of phrenic nerve injury at baseline elicited by hemidiaphragmatic paralysis on pre-ablation chest x-ray
About this study
Official title: CryobAllooN Targeting Atrial fibRosIs in Atrial Fibrillation
Pulmonary vein isolation (PVI) using cryoballoon ablation is a well-established procedure for the treatment of atrial fibrillation (AF). However, the use of cryoballoon ablation in recent clinical trials have been limited to PVI. As such, patients with paroxysmal AF have been the main recipients of this procedure. In patients with persistent AF, or patients with paroxysmal AF and significant AF substrate other than the pulmonary veins, the utility of cryoballoon ablation is less straightforward. In such patients, the choices are to either use cryoballoon ablation in a PVI-only approach or alternatively, use cryoballoon ablation for PVI followed by the use of radiofrequency ablation for additional ablation and/or substrate modification.
Substrate modification by targeting left atrial fibrosis detected on delayed enhancement magnetic resonance imaging (DE-MRI) is an increasingly popular approach with growing data showing its utility to decrease the risk of recurrence. The ability to use cryoballoon ablation for fibrosis based ablation in addition to PVI will therefore provide a significant advantage.
This study will evaluate feasibility and the outcome of targeted ablation of left atrial fibrosis detected on DE-MRI in addition to pulmonary vein isolation using the Arctic Front Advance Cryoballoon Catheter.
Read the detailed description
This is a single center open-label pilot study to be performed at the University of Utah Hospital. Patients that are referred for first time ablation of paroxysmal or persistent atrial fibrillation (AF) will be considered to be enrolled in the study. An electrocardiogram (ECG) will be performed at the time of the first clinic visit with the documentation of the rhythm. All patients will be started on an oral anticoagulation (either a novel anticoagulation agent or warfarin with a targeted international normalized ratio (INR) of 2-3). All patients will have a basic metabolic panel, complete blood count, prothrombin time/INR, thyroid-stimulating hormone, and a chest x-ray at the time of the first clinic visit. Women of childbearing potential will have a β-human chorionic gonadotropin test to rule out pregnancy. Within a month prior to the planned ablation, all patients will undergo a DE-MRI to assess pulmonary vein anatomy, fibrosis burden and distribution, and left ventricular function.
All patients will undergo a transesophageal echocardiogram immediately prior to the ablation procedure to rule out thrombus within the left atrial appendage. If thrombus is detected, the procedure will be postponed. AF ablation procedure will consist of pulmonary vein isolation using the Medtronic Arctic Front Advance Cryoballoon Catheter. Following PVI, additional lesions will be placed targeting areas of fibrosis by further manipulation of the catheter from its position within pulmonary vein.
Following ablation, all patients will be observed for 24 hours to assess immediate post procedural complications. All patients will be continued on anticoagulation for at least two months. Patients may be continued on oral anticoagulation beyond two months post-ablation if they are determined to have a high stroke risk profile.
A DE-MRI will be performed on all patients within 24 hours of ablation to assess esophageal thermal injury. Patients with severe esophageal enhancement will have a repeat DE-MRI within 24 hours. Patients with moderate enhancement will have a repeat DE-MRI within 1 week. All patients with persistent esophageal enhancement on repeat DE-MRI will be referred for esophagogastroduodenoscopy. All patients will be placed on a proton pump inhibitor for 1 month.
All patients will be discharged with a 60-day event monitor. Continuation of antiarrhythmic medications will be at the discretion of the performing physician. Following the procedure, a 90-day blanking period will start. Following the blanking period, patients will be monitored for one year for recurrence of AF. Recurrence of AF is defined as a detectable episode of AF, atrial flutter, or atrial tachycardia lasting at least 30 seconds. AF recurrence will be assessed by 30-day event monitors at 3, 6, and 12-months following the blanking period. A chest x-ray will be performed in all patients at the time of their first follow up visit.
All patients will undergo a DE-MRI at 3 months at the time which ablation scar size and burden, progression of left atrial fibrosis as well as presence of pulmonary vein stenosis will be assessed.
- Conditions
- Atrial Fibrillation, Left Atrial Fibrosis
- Being tested
- Cryoballoon Ablation: PVI + substrate modification
- Keywords
- Cryoballoon Ablation, Persistent atrial fibrillation, Paroxysmal atrial fibrillation
- 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: PVI + substrate modificationDevice
Standard pulmonary vein isolation using cryoballoon ablation, followed by left atrial fibrosis substrate modification using cryoballoon ablation
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon Ablation | Experimental | Cryoballoon Ablation: PVI + substrate modification. Left atrial fibrosis ablation in addition to standard pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. Ablation will be performed utilizing the Medtronic Arctic Front Advance Cryoballoon catheter. Receives: Device: Cryoballoon Ablation: PVI + substrate modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Atrial Fibrillation
Recurrence of atrial fibrillation will be defined by detection of an episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds during any of the study follow-up periods up to one year post-ablation.
Measured: 12 Months
Secondary outcomes (1)
Recurrence of Atrial Fibrillation Stratified by Atrial Fibrillation Type
Recurrence of atrial fibrillation type will be compared to historical data of ablations targeting only pulmonary vein isolation
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study startOct 2019 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Why it stopped: Sponsor-Investigator left the institution
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.
- More trials run by University of UtahThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-center, open-label pilot study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Nassir F Marrouche, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489096
- Sponsor's protocol ID
- IRB_00109729
- Acronym
- CANARI-AF
- Status last verified
- Jul 2019
- First submitted
- 28 Mar 2018
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CryobAllooN Targeting Atrial fibRosIs in Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03489096
- Acronym / sponsor ID
- CANARI-AF / IRB_00109729
- Conditions
- Atrial Fibrillation, Left Atrial Fibrosis
- Keywords
- Cryoballoon Ablation, Persistent atrial fibrillation, Paroxysmal atrial fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor-Investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 5 Apr 2018 (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.
Pulmonary vein isolation (PVI) using cryoballoon ablation is a well-established procedure for the treatment of atrial fibrillation (AF). However, the use of cryoballoon ablation in recent clinical trials have been limited to PVI. As such, patients with paroxysmal AF have been the main recipients of this procedure. In patients with persistent AF, or patients with paroxysmal AF and significant AF substrate other than the pulmonary veins, the utility of cryoballoon ablation is less straightforward. In such patients, the choices are to either use cryoballoon ablation in a PVI-only approach or alternatively, use cryoballoon ablation for PVI followed by the use of radiofrequency ablation for additional ablation and/or substrate modification.
Substrate modification by targeting left atrial fibrosis detected on delayed enhancement magnetic resonance imaging (DE-MRI) is an increasingly popular approach with growing data showing its utility to decrease the risk of recurrence. The ability to use cryoballoon ablation for fibrosis based ablation in addition to PVI will therefore provide a significant advantage.
This study will evaluate feasibility and the outcome of targeted ablation of left atrial fibrosis detected on DE-MRI in addition to pulmonary vein isolation using the Arctic Front Advance Cryoballoon Catheter.
Detailed description
This is a single center open-label pilot study to be performed at the University of Utah Hospital. Patients that are referred for first time ablation of paroxysmal or persistent atrial fibrillation (AF) will be considered to be enrolled in the study. An electrocardiogram (ECG) will be performed at the time of the first clinic visit with the documentation of the rhythm. All patients will be started on an oral anticoagulation (either a novel anticoagulation agent or warfarin with a targeted international normalized ratio (INR) of 2-3). All patients will have a basic metabolic panel, complete blood count, prothrombin time/INR, thyroid-stimulating hormone, and a chest x-ray at the time of the first clinic visit. Women of childbearing potential will have a β-human chorionic gonadotropin test to rule out pregnancy. Within a month prior to the planned ablation, all patients will undergo a DE-MRI to assess pulmonary vein anatomy, fibrosis burden and distribution, and left ventricular function.
All patients will undergo a transesophageal echocardiogram immediately prior to the ablation procedure to rule out thrombus within the left atrial appendage. If thrombus is detected, the procedure will be postponed. AF ablation procedure will consist of pulmonary vein isolation using the Medtronic Arctic Front Advance Cryoballoon Catheter. Following PVI, additional lesions will be placed targeting areas of fibrosis by further manipulation of the catheter from its position within pulmonary vein.
Following ablation, all patients will be observed for 24 hours to assess immediate post procedural complications. All patients will be continued on anticoagulation for at least two months. Patients may be continued on oral anticoagulation beyond two months post-ablation if they are determined to have a high stroke risk profile.
A DE-MRI will be performed on all patients within 24 hours of ablation to assess esophageal thermal injury. Patients with severe esophageal enhancement will have a repeat DE-MRI within 24 hours. Patients with moderate enhancement will have a repeat DE-MRI within 1 week. All patients with persistent esophageal enhancement on repeat DE-MRI will be referred for esophagogastroduodenoscopy. All patients will be placed on a proton pump inhibitor for 1 month.
All patients will be discharged with a 60-day event monitor. Continuation of antiarrhythmic medications will be at the discretion of the performing physician. Following the procedure, a 90-day blanking period will start. Following the blanking period, patients will be monitored for one year for recurrence of AF. Recurrence of AF is defined as a detectable episode of AF, atrial flutter, or atrial tachycardia lasting at least 30 seconds. AF recurrence will be assessed by 30-day event monitors at 3, 6, and 12-months following the blanking period. A chest x-ray will be performed in all patients at the time of their first follow up visit.
All patients will undergo a DE-MRI at 3 months at the time which ablation scar size and burden, progression of left atrial fibrosis as well as presence of pulmonary vein stenosis will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-center, open-label pilot study
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon Ablation | Experimental | Device: Cryoballoon Ablation: PVI + substrate modificationCryoballoon Ablation: PVI + substrate modification. Left atrial fibrosis ablation in addition to standard pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. Ablation will be performed utilizing the Medtronic Arctic Front Advance Cryoballoon catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Referred for cryoballoon ablation of paroxysmal or persistent atrial fibrillation
- 18 years of age or older
- Ability to give informed consent in accordance with University of Utah IRB guidelines
Key exclusion criteria (14 listed)
- Previous ablation for atrial fibrillation or atypical atrial flutter
- Contraindication to MRI contrast agent
- Unquantifiable fibrosis or moderate to severe left-atrial fibrosis (≥ 20%)
- Contraindication for chronic anticoagulation therapy
- Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular disease within the last 2 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: PVI + substrate modificationStandard pulmonary vein isolation using cryoballoon ablation, followed by left atrial fibrosis substrate modification using cryoballoon ablation | Device | Cryoballoon Ablation |
Primary outcome
Recurrence of Atrial Fibrillation
Time frame: 12 Months
Recurrence of atrial fibrillation will be defined by detection of an episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting for more than 30 seconds during any of the study follow-up periods up to one year post-ablation.
1 secondary outcome
Recurrence of Atrial Fibrillation Stratified by Atrial Fibrillation Type
Time frame: 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Nassir F Marrouche, M.D. principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon Ablation: PVI + substrate modification in people with Atrial Fibrillation and Left Atrial Fibrosis, run by University of Utah.
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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Recurrence of Atrial Fibrillation (time frame: 12 Months). 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 19 Jul 2019.