N/A
N=143
LSI (Lesion Index) Workflow Observational Study
Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03906461 ↗Enrolled (actual)
143
Serious AEs
0.7%
Results posted
Aug 2024
Primary outcome: Primary: Mean Achieved Lesion Index (LSI) Values — 4.9; 4.8; 4.9; 4.7 Lesion Index
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Radiofrequency Ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Achieved Lesion Index (LSI) Values |
4.9; 4.8; 4.9; 4.7; 5.1; 5.0 | — |
| SECONDARY Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters |
14.4; 7.1; 3.2 | — |
| SECONDARY Ensite AutoMark Settings and Characteristics: Average RF Power Delivered |
38.0 | — |
| SECONDARY Ensite AutoMark Settings and Characteristics: Contact Force |
11.7 | — |
| SECONDARY Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter |
5.7 | — |
| SECONDARY Number of Participants With Acute Electrical Isolation of Pulmonary Veins |
143 | — |
| SECONDARY Number of Participants With 7-Day Device or Procedure Related SAEs |
1 | — |
| SECONDARY Number of Participants With 12-Month Device or Procedure Related SAEs |
1 | — |
| SECONDARY Number of Participants With Freedom From AF/AFL/AT Recurrence |
112 | — |
| SECONDARY Number of Participants With Repeat Ablation |
3 | — |
| SECONDARY Number of Participants That Required Touch up Ablation in Each Region |
5; 7; 5; 5; 3; 7 | — |
| SECONDARY Number of Participants in Which Pulmonary Veins Required Touch-up Ablation |
11; 7; 9; 6 | — |
| SECONDARY Number of Participants That Required Index Procedure Touch-up Ablations |
34 | — |
| SECONDARY LSI Achieved Values for Repeat RF Ablations |
NA | — |
| SECONDARY Overall Procedure Time |
55.6; 7.4; 22.5; 142.5 | — |
| SECONDARY Overall RF Ablation Time |
19.3; 2.6; 22.1 | — |
| SECONDARY Overall Fluoroscopy Time |
23.7 | — |
| SECONDARY Quality of Life Changes 6-Month |
20.8; 6.3 | — |
| SECONDARY Quality of Life Changes 12-Month |
23.8; 7.6 | — |
| SECONDARY Number of Participants on Antiarrhythmic Drugs |
52 | — |
| SECONDARY Number of Participants With Health Care Utilization |
13 | — |
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 real-word environment.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03906461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.