Atrial FibrillationNCT04363307
Prospective Study to Validate Ablation Parameters with MRI Based Scar for Left Atrial Ablation
An observational study of Atrial Fibrillation, run by Ravi Ranjan at 1 site in United States.
Trial summary
One of the goals of an ablation procedure is to create scarring of cardiac tissue. Not all ablations result in scar tissue. Advances in technology have improved scarring but ideal parameters that result in scar tissue are still not completely clear and there is great variability in the parameters used. 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?
- AF Ablation and MRI
- Type of treatment
- Medical device
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2020to 31 Jul 2023
- Phase
- Observational
- 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
Study population: All participants ages 18 or older with paroxysmal or early persistent AF who will undergo their first ablation.
Who may be able to join
- Paroxysmal or early Persistent AF (continuous AF duration less than 3 months and CHADSVASC great than or equal to 2).
- First time ablation for AF
- Agreeable to a 3 month MRI
Who cannot join
- Claustrophobic (unable to undergo MRI)
- Having undergone prior left atrial ablation including AT or atypical flutter
- Metal implants that preclude getting an MRI
- eGFR < 30
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
One of the goals of an ablation procedure is to create scarring of cardiac tissue. Not all ablations result in scar tissue. Advances in technology have improved scarring but ideal parameters that result in scar tissue are still not completely clear and there is great variability in the parameters used. Theoretically, intense ablation can always create scar tissue but is also likely to create more complications such as cardiac perforations. The investigator recently published another retrospective study looking at ablation parameters that reliably result in scar tissue but it had its limitations as it was retrospectively done.
This is a prospective study to validate the parameters that result in long term scarring. MRI has long been used to visualize ablation scar tissue. So in this study patients undergoing, initial left atrial ablation for atrial fibrillation as standard of care will undergo a 3 month post ablation MRI and that will be used to validate the ablation parameters.
Read the detailed description
A critical step to improve atrial fibrillation (AF) ablation broadly is to minimize interoperator variability. VISITAG SURPOINT calculated a marker tag index value by combining contact force, power setting, and duration of energy delivered. Use of VISITAG SURPOINT has accurately predicted sites of pulmonary vein reconnection and regional changes in late gadolinium enhancement (LGE) and T2 (edema) intensity 24 hours post ablation. Prospective use of the ablation index improves first pass pulmonary vein isolation and 1-year freedom from atrial tachyarrhythmias compared to conventional treatment.
There remains a paucity of data regarding if ablation guided by index values and VISITAG SURPOINT results in durable scar formation in humans in general and compared to conventional approaches. In addition, the relative contribution of the components of VISITAG SURPOINT impact scar formation in-vivo and across a broad diversity of atrial anatomies. Such data are critical in patients that present with various degrees of atrial myopathies, arrhythmia substrate, and anatomies.
- Conditions
- Atrial Fibrillation
- Being tested
- AF Ablation, MRI
- Keywords
- Atrial fibrillation, Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF AblationDevice
Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT
MRIDevice
Adult participants will undergo a late gadolinium enhancement MRI of the left atrium three months post standard of care ablation
| Study group | Role | What they receive |
|---|---|---|
| Adult participants | Adult participants ages 18 and older with AF Receives: Device: AF Ablation; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of ablative force with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Measured: 3 months
Correlation of ablative power with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Measured: 3 months
Correlation of ablation time on scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Measured: 3 months
Secondary outcomes (1)
Change in circumferential extent of the lesion around pulmonary veins after ablation as measured by scar area
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2020
- Study start14 May 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ravi Ranjan
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, Ravi Ranjan, University of Utah
- Investigators
- Ravi Ranjan, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04363307
- Sponsor's protocol ID
- IRB_00130480
- Status last verified
- Oct 2024
- First submitted
- 23 Apr 2020
- Last updated
- 1 Nov 2024
- 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 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Validate Ablation Parameters with MRI Based Scar for Left Atrial Ablation
- ClinicalTrials.gov ID
- NCT04363307
- Acronym / sponsor ID
- IRB_00130480
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ravi RanjanUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 14 May 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 27 Apr 2020 (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.
One of the goals of an ablation procedure is to create scarring of cardiac tissue. Not all ablations result in scar tissue. Advances in technology have improved scarring but ideal parameters that result in scar tissue are still not completely clear and there is great variability in the parameters used. Theoretically, intense ablation can always create scar tissue but is also likely to create more complications such as cardiac perforations. The investigator recently published another retrospective study looking at ablation parameters that reliably result in scar tissue but it had its limitations as it was retrospectively done.
This is a prospective study to validate the parameters that result in long term scarring. MRI has long been used to visualize ablation scar tissue. So in this study patients undergoing, initial left atrial ablation for atrial fibrillation as standard of care will undergo a 3 month post ablation MRI and that will be used to validate the ablation parameters.
Detailed description
A critical step to improve atrial fibrillation (AF) ablation broadly is to minimize interoperator variability. VISITAG SURPOINT calculated a marker tag index value by combining contact force, power setting, and duration of energy delivered. Use of VISITAG SURPOINT has accurately predicted sites of pulmonary vein reconnection and regional changes in late gadolinium enhancement (LGE) and T2 (edema) intensity 24 hours post ablation. Prospective use of the ablation index improves first pass pulmonary vein isolation and 1-year freedom from atrial tachyarrhythmias compared to conventional treatment.
There remains a paucity of data regarding if ablation guided by index values and VISITAG SURPOINT results in durable scar formation in humans in general and compared to conventional approaches. In addition, the relative contribution of the components of VISITAG SURPOINT impact scar formation in-vivo and across a broad diversity of atrial anatomies. Such data are critical in patients that present with various degrees of atrial myopathies, arrhythmia substrate, and anatomies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult participants | – | Device: AF Ablation, Device: MRIAdult participants ages 18 and older with AF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants ages 18 or older with paroxysmal or early persistent AF who will undergo their first ablation.
Key inclusion criteria (3 listed)
- Paroxysmal or early Persistent AF (continuous AF duration less than 3 months and CHADSVASC great than or equal to 2).
- First time ablation for AF
- Agreeable to a 3 month MRI
Key exclusion criteria (4 listed)
- Claustrophobic (unable to undergo MRI)
- Having undergone prior left atrial ablation including AT or atypical flutter
- Metal implants that preclude getting an MRI
- eGFR < 30
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 |
|---|---|---|
| AF AblationAdult participants undergoing standard of care AF ablation using VISITAG SURPOINT | Device | Adult participants |
| MRIAdult participants will undergo a late gadolinium enhancement MRI of the left atrium three months post standard of care ablation | Device | Adult participants |
Primary outcome
Correlation of ablative force with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Time frame: 3 months
Correlation of ablative power with scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Time frame: 3 months
Correlation of ablation time on scar formation, on a scale of 0 (no correlation) to 1 (total correlation)
Time frame: 3 months
1 secondary outcome
Change in circumferential extent of the lesion around pulmonary veins after ablation as measured by scar area
Time frame: 3 months
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 1 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Ravi Ranjan, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Ravi Ranjan 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 4 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 1 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 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.
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?
Correlation of ablative force with scar formation, on a scale of 0 (no correlation) to 1 (total correlation) (time frame: 3 months). 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 1 Nov 2024.