Atrial FibrillationPhase 4LAMDENCT02875730
A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium Enhancement
A Phase 4 study testing Pulse Sequence and CMRI in people with Atrial Fibrillation and Cryoablation, run by Aspire Foundation at 1 site in United States.
Trial summary
This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Cryoablation
- What is being tested?
- Pulse Sequence and CMRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2016to 27 Apr 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or non-pregnant women
- A diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure
- Documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation.
Who cannot join
- Contraindication to MRI, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits
- Allergy to gadolinium-based contrast agent
- Previous atrial fibrillation ablation
- Renal dysfunction (estimated GFR <60 mL/min/1.73m2) within 6 months
- Unwilling to provide informed consent for this protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Health System
Kansas City, Missouri, 64111
About this study
Official title: A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium
This is a prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.
- Conditions
- Atrial Fibrillation, Cryoablation
- Being tested
- Pulse Sequence, CMRI
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse SequenceProcedure or surgery
Cylindrical Navigator Preparatory Pulse Sequence
CMRIProcedure or surgery
Cardiac Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| CMRI Pulse Sequence | Experimental | Patients will have late gadolinium cardiac magnetic resonance images of the individual pulmonary veins acquired with the standard and the cylindrical navigator preparatory pulse sequences for comparison. Receives: Procedure: Pulse Sequence; Procedure: CMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pool Corrected Signal Intensity
Measured: Through study completion, an average of 1 year
Imaging Failure Rate
Measured: Through study completion, an average of 1 year
Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start13 Dec 2016
- Primary completion6 Mar 2018
- Study completion27 Apr 2018
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspire Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875730
- Sponsor's protocol ID
- 16-044
- Acronym
- LAMDE
- Status last verified
- Jun 2018
- First submitted
- 16 Aug 2016
- Last updated
- 29 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Investigation Detecting Cryoablation Scar by 3D Late Gadolinium
- ClinicalTrials.gov ID
- NCT02875730
- Acronym / sponsor ID
- LAMDE / 16-044
- Conditions
- Atrial Fibrillation, Cryoablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Aspire FoundationUniversity, hospital or other
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 27 Apr 2018 (actual)
- First posted
- 23 Aug 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 prospective trial investigating the effectiveness of a modified MRI preparatory pulse sequence to improve pulmonary vein isolation visualization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMRI Pulse Sequence | Experimental | Procedure: Pulse Sequence, Procedure: CMRIPatients will have late gadolinium cardiac magnetic resonance images of the individual pulmonary veins acquired with the standard and the cylindrical navigator preparatory pulse sequences for comparison. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or non-pregnant women
- A diagnosis of symptomatic paroxysmal or recently persistent atrial fibrillation with a documented successful cardioversion within 4 months of the procedure
- Documented treatment failure or intolerance of at least 1 anti-arrhythmic medication used to control atrial fibrillation.
Key exclusion criteria (5 listed)
- Contraindication to MRI, such as implanted incompatible metal prosthesis, or subject size exceeds bore or table limits
- Allergy to gadolinium-based contrast agent
- Previous atrial fibrillation ablation
- Renal dysfunction (estimated GFR <60 mL/min/1.73m2) within 6 months
- Unwilling to provide informed consent for this protocol
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 |
|---|---|---|
| Pulse SequenceCylindrical Navigator Preparatory Pulse Sequence | Procedure or surgery | CMRI Pulse Sequence |
| CMRICardiac Magnetic Resonance Imaging | Procedure or surgery | CMRI Pulse Sequence |
Primary outcome
Blood Pool Corrected Signal Intensity
Time frame: Through study completion, an average of 1 year
Imaging Failure Rate
Time frame: Through study completion, an average of 1 year
Extent of Detected LGE Signal Correlate to the Respiratory Navigator Scheme
Time frame: Through study completion, an average of 1 year
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 29 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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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
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulse Sequence and CMRI in people with Atrial Fibrillation and Cryoablation, run by Aspire Foundation at 1 site in United States.
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 5 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 29 Jun 2018. 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 United States. 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?
Blood Pool Corrected Signal Intensity (time frame: Through study completion, an average of 1 year). 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 29 Jun 2018.