LSI (Lesion Index) Workflow Observational Study

Abbott

Status: Completed

Conditions: Paroxysmal Atrial Fibrillation

Treatments: Device: Radiofrequency Ablation

Study type: Observational

Funder types: Industry

Identifiers

NCT03906461

ABT-CIP-10276

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject must provide written informed consent prior to any clinical investigation related procedure.

2. Subject is at least 18 years of age.

3. Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.

4. Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.

5. 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:

     1. Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason.
     2. Subject was offered the drug and refused to take for any reason.

Exclusion criteria

1. Previous ablation or surgery in the left atria.
2. Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).
3. Participation in another clinical investigation that may confound the results of this study.
4. Pregnant or nursing.
5. 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.
6. Life expectancy less than 12 months.

Trial design