Paroxysmal Atrial FibrillationNCT03906461
LSI (Lesion Index) Workflow Observational Study
An observational study of Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 9 sites in 5 countries.
Trial summary
This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Medical device
- How many people
- 143 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 17 May 2019to 27 Apr 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: This clinical investigation will enroll male and female subjects undergoing their first ablation procedure from the documented drug-refractory, paroxysmal atrial fibrillation (PAF) population. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
Who may be able to join
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- Subject is at least 18 years of age.
- Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.
- Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.
- Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug.
- For the purposes of this study, "intolerant" includes either:
- Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason.
- Subject was offered the drug and refused to take for any reason.
Who cannot join
- Previous ablation or surgery in the left atria.
- Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).
- Participation in another clinical investigation that may confound the results of this study.
- Pregnant or nursing.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- Life expectancy less than 12 months.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
United States4 sites
Maimonides Medical Center
Brooklyn, New York, 11219
Mills-Peninsula Medical Center
Burlingame, California, 94010
St. Vincent Hospital
Indianapolis, Indiana, 46260
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Japan2 sites
Tokyo Medical and Dental University Hospital of Medicine
Bunkyō-Ku, Tokyo, 113-8510
The Jikei University Katsushika Medical Center
Katsushikachō, Tokyo, 125-8506
About this study
Official title: LSI (Lesion Index) Workflow Post-Market Observational Study
This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-word environment.
Read the detailed description
The primary objective of this study is to characterize LSI achieved values for durable lesion formation using the TactiCath SE catheter in the different anatomical regions around the pulmonary veins (PVs) of the heart during RF ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF)
Secondary objectives of this study are as follows:
- To characterize the use of EnSite Automap and AutoMark module software settings, including LSI threshold (OUS), contact force, time, power, flow, and AutoMark spacing using the TactiCath SE catheter for RF ablation for the treatment of drug-refractory PAF.
- To characterize LSI achieved values for lesions that reconnected versus those that were durable, both in an acute procedural setting as well as in patients who undergo additional ablations during the 12-month follow-up period after an index RF ablation procedure for the treatment of drug-refractory PAF.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Radiofrequency 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.
Radiofrequency AblationDevice
The Tacticath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) is designed to facilitate electrophysiological mapping of the heart chambers and to transmit radiofrequency (RF) current to the catheter tip electrode for intracardiac ablation purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Achieved Lesion Index (LSI) Values
The primary endpoint is a summary of Lesion Index (LSI) values achieved for radiofrequency ablation catheter lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). LSI is a proprietary index that combines contact force, radiofrequency duration, and radiofrequency current into a single value to express the gradual growth of lesion formation with increasing LSI values.
Measured: At time of procedure
Secondary outcomes (20)
Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters
Descriptive summary of EnSite AutoMark module software settings and characteristics, including time and AutoMark Time parameters for each lesion. Away time refers to the maximum amount of time the catheter can remain away from the AutoMark region before a new AutoMark will be placed. The AutoMark minimum lesion time refers to the minimum amount of time the catheter tip must remain within the AutoMark region before an AutoMark lesion is placed.
Measured: At time of procedure
Ensite AutoMark Settings and Characteristics: Average RF Power Delivered
Descriptive summary of EnSite AutoMark module software settings and characteristics, including average radiofrequency (RF) power delivered for each lesion
Measured: At time of procedure
Ensite AutoMark Settings and Characteristics: Contact Force
Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion
Measured: At time of procedure
Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter
Descriptive summary of EnSite AutoMark module software settings and characteristics, including AutoMark Lesion Spacing parameter for each lesion
Measured: At time of procedure
Number of Participants With Acute Electrical Isolation of Pulmonary Veins
Acute electrical isolation of the pulmonary veins (PVs), 20 minutes after the last RF ablation in the PV region. The number of participants with acute electric isolation of all pulmonary veins is reported.
Measured: 20 minutes after last RF ablation in PV region
Number of Participants With 7-Day Device or Procedure Related SAEs
Device- or procedure-related SAEs within 7-days of the index procedure
Measured: within 7-days of index procedure
Number of Participants With 12-Month Device or Procedure Related SAEs
Device- or procedure-related SAEs within 12-months of index procedure
Measured: between 7 days and 12-months of index procedure
Number of Participants With Freedom From AF/AFL/AT Recurrence
Freedom from documented AF/AFL/AT recurrence at 12-months post index ablation, excluding a 90-day blanking period. Freedom from AF/AFL/AT recurrence is defined as no documented episodes greater than 30 seconds with a 24-hour Holter.
Measured: No documented episodes greater than 30 seconds with a 24hour-Holter
Number of Participants With Repeat Ablation
Participants with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period)
Measured: 12-months post index procedure (excluding 90-day blanking period)
Number of Participants That Required Touch up Ablation in Each Region
Participants with regions that required touch up ablation.
Measured: At time of procedure
Number of Participants in Which Pulmonary Veins Required Touch-up Ablation
Participants that required touch-up ablation of each pulmonary vein (PV).
Measured: At time of procedure
Number of Participants That Required Index Procedure Touch-up Ablations
Participants who required at least one touch-up ablation during the index procedure
Measured: At time of procedure
LSI Achieved Values for Repeat RF Ablations
In participants who undergo any repeat RF ablation procedures up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable
Measured: up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable
Overall Procedure Time
Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations
Measured: At time of procedure
Overall RF Ablation Time
Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, and any touch-up ablations
Measured: At time of procedure
Overall Fluoroscopy Time
Overall fluoroscopy time
Measured: At time of procedure
Quality of Life Changes 6-Month
Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 6-months post index ablation, compared to baseline scores.
AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.
EQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.
Measured: 6 months post index ablation, compared to baseline scores
Quality of Life Changes 12-Month
Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 12-months post index ablation, compared to baseline scores.
AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.
EQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.
Measured: 12-months post index ablation, compared to baseline scores
Number of Participants on Antiarrhythmic Drugs
Antiarrhythmic drug use at 12-months
Measured: 12-months
Number of Participants With Health Care Utilization
Health care utilization (including number of unscheduled hospital outpatient/ER visits and inpatient hospitalizations due to arrhythmias) collected throughout the 12-month follow-up period
Measured: collected throughout the 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start17 May 2019
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristen Ruffner, PhD, Study director, EP Program Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906461
- Sponsor's protocol ID
- ABT-CIP-10276
- Status last verified
- Feb 2024
- First submitted
- 29 Mar 2019
- Last updated
- 2 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: TBD via publication plan
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LSI (Lesion Index) Workflow Post-Market Observational Study
- ClinicalTrials.gov ID
- NCT03906461
- Acronym / sponsor ID
- ABT-CIP-10276
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 17 May 2019 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Posted 2 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-word environment.
Detailed description
The primary objective of this study is to characterize LSI achieved values for durable lesion formation using the TactiCath SE catheter in the different anatomical regions around the pulmonary veins (PVs) of the heart during RF ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF)
Secondary objectives of this study are as follows:
- To characterize the use of EnSite Automap and AutoMark module software settings, including LSI threshold (OUS), contact force, time, power, flow, and AutoMark spacing using the TactiCath SE catheter for RF ablation for the treatment of drug-refractory PAF.
- To characterize LSI achieved values for lesions that reconnected versus those that were durable, both in an acute procedural setting as well as in patients who undergo additional ablations during the 12-month follow-up period after an index RF ablation procedure for the treatment of drug-refractory PAF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical investigation will enroll male and female subjects undergoing their first ablation procedure from the documented drug-refractory, paroxysmal atrial fibrillation (PAF) population. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.
Key inclusion criteria (8 listed)
- Subject must provide written informed consent prior to any clinical investigation related procedure.
- Subject is at least 18 years of age.
- Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.
- Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.
- Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug.
Key exclusion criteria (6 listed)
- Previous ablation or surgery in the left atria.
- Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).
- Participation in another clinical investigation that may confound the results of this study.
- Pregnant or nursing.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
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 |
|---|---|---|
| Radiofrequency AblationThe Tacticath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) is designed to facilitate electrophysiological mapping of the heart chambers and to transmit radiofrequency (RF) current to the catheter tip electrode for intracardiac ablation purposes. | Device | – |
Primary outcome
Mean Achieved Lesion Index (LSI) Values
Time frame: At time of procedure
The primary endpoint is a summary of Lesion Index (LSI) values achieved for radiofrequency ablation catheter lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). LSI is a proprietary index that combines contact force, radiofrequency duration, and radiofrequency current into a single value to express the gradual growth of lesion formation with increasing LSI values.
20 secondary outcomes
Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters
Time frame: At time of procedure
Ensite AutoMark Settings and Characteristics: Average RF Power Delivered
Time frame: At time of procedure
Ensite AutoMark Settings and Characteristics: Contact Force
Time frame: At time of procedure
Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter
Time frame: At time of procedure
Number of Participants With Acute Electrical Isolation of Pulmonary Veins
Time frame: 20 minutes after last RF ablation in PV region
Number of Participants With 7-Day Device or Procedure Related SAEs
Time frame: within 7-days of index procedure
Number of Participants With 12-Month Device or Procedure Related SAEs
Time frame: between 7 days and 12-months of index procedure
Number of Participants With Freedom From AF/AFL/AT Recurrence
Time frame: No documented episodes greater than 30 seconds with a 24hour-Holter
Number of Participants With Repeat Ablation
Time frame: 12-months post index procedure (excluding 90-day blanking period)
Number of Participants That Required Touch up Ablation in Each Region
Time frame: At time of procedure
Number of Participants in Which Pulmonary Veins Required Touch-up Ablation
Time frame: At time of procedure
Number of Participants That Required Index Procedure Touch-up Ablations
Time frame: At time of procedure
LSI Achieved Values for Repeat RF Ablations
Time frame: up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable
Overall Procedure Time
Time frame: At time of procedure
Overall RF Ablation Time
Time frame: At time of procedure
Overall Fluoroscopy Time
Time frame: At time of procedure
Quality of Life Changes 6-Month
Time frame: 6 months post index ablation, compared to baseline scores
Quality of Life Changes 12-Month
Time frame: 12-months post index ablation, compared to baseline scores
Number of Participants on Antiarrhythmic Drugs
Time frame: 12-months
Number of Participants With Health Care Utilization
Time frame: collected throughout the 12-month follow-up period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. TBD via publication plan
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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.
Kristen Ruffner, PhD study director
EP Program Director
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Abbott Medical Devices at 9 sites in 5 countries.
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 8 inclusion and 6 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 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Japan, Germany, Italy, Spain. 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?
Yes. Results are posted in the registry (first posted 2 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Achieved Lesion Index (LSI) Values (time frame: At time of procedure). 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 2 Aug 2024.