LSI (Lesion Index) Workflow Observational Study

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

LSI (Lesion Index) Workflow Post-Market Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906461
• Other study ID #: ABT-CIP-10276
• Status: Completed
• Start date: May 17, 2019
• Est. completion date: April 27, 2021

Study information

• Verified date: May 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 real-word environment.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Device:
• Radiofrequency Ablation
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.

Locations

Country	Name	City	State
Germany	St. Johannes Hospital	Dortmund
Italy	Ospedale Santa Maria del Prato	Feltre
Japan	Tokyo Medical and Dental University Hospital of Medicine	Bunkyo-Ku	Tokyo
Japan	The Jikei University Katsushika Medical Center	Katsushikacho	Tokyo
Spain	Hospital Universitario de Monteprincipe	Boadilla del Monte
United States	Maimonides Medical Center	Brooklyn	New York
United States	Mills-Peninsula Medical Center	Burlingame	California
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	North Mississippi Medical Center	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary LSI-Achieved Value Endpoint	The primary endpoint is a summary of LSI values achieved for RF lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs).	At time of procedure
Secondary	Ensite AutoMap and AutoMark settings	Descriptive summary of EnSite AutoMap and AutoMark module software settings, including LSI threshold settings (in OUS), contact force, time, power, flow settings, and AutoMark spacing for each procedure	At time of procedure
Secondary	Electic Isolation of Pulmonary Veins	Acute electrical isolation of PVs, 20 minutes after last RF ablation in PV region	20 minutes after last RF ablation in PV region
Secondary	7-Day Device or Procedure related SAE rate	Device- or procedure-related SAEs within 7-days and 12-months of index procedure	within 7-days of index procedure
Secondary	12-Month Device or Procedure related SAE rate	Device- or procedure-related SAEs within 7-days and 12-months of index procedure	within 12-months of index procedure
Secondary	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	No documented episodes greater than 30 seconds with a 24hour-Holter
Secondary	Repeat Ablation Proportion	Proportion of patients with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period)	12-months post index procedure (excluding 90-day blanking period)
Secondary	First-pass PVI lesion	Proportion of lesions generated during first-pass PVI that required touch-up ablation	At time of procedure
Secondary	Touch-up ablation of pulmonary viens	Proportion of pulmonary veins (PVs) requiring touch-up ablation	At time of procedure
Secondary	Index procedure touch-up ablations	Proportion of patients who required at least one touch-up ablation during the index procedure	At time of procedure
Secondary	LSI achieved values for repeat RF ablations	In patients 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	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
Secondary	Overall procedure time	Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations	At time of procedure
Secondary	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	At time of procedure
Secondary	Overall fluro time	Overall fluoroscopy time	At time of procedure
Secondary	Quality of life changes 6-Month	Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-months post index ablation, compared to baseline scores	6 months post index ablation, compared to baseline scores
Secondary	Quality of life changes 12-Month	Changes in EQ-5D-5L and AFEQT quality of life scores at 6- and 12-months post index ablation, compared to baseline scores	12-months post index ablation, compared to baseline scores
Secondary	Antiarrhythmia medication	AAD use at 12-months	12-months
Secondary	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	collected throughout the 12-month follow-up period