Trial Outcomes & Findings for TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation (NCT NCT03354663)

Last Updated: 2023-10-11

Results Overview

The primary safety endpoint is the rate of device or procedure-related serious adverse events occurring within 7 days of the index procedure. SAEs related solely to arrhythmia recurrence (without coexisting conditions such as thromboembolism, worsening heart failure, etc.) will not be considered primary safety endpoint events. The SAEs that will be included in this endpoint are: * Atrial-esophageal fistula * AV block * Cardiac Perforation/ Tamponade * Death * Diaphragmatic paralysis * Gastroparesis * Hospitalization * Myocardial Infarction * Pericarditis * Pneumothorax * Pulmonary edema * Pulmonary vein stenosis * Stroke * Thromboembolism * Transient ischemic attack * Vascular access complications Atrial-esophageal fistula, cardiac perforation/tamponade, and pulmonary vein stenosis that occur \>7 days post procedure through 30 days will also contribute to the primary endpoint.

Recruitment status

COMPLETED

Study phase

Target enrollment

156 participants

Primary outcome timeframe

30 days

Results posted on

2023-10-11

Participant Flow

Participant milestones

Participant milestones
Measure	TactiCath SE Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation.
Enrollment to Catheter Insertion STARTED	156
Enrollment to Catheter Insertion COMPLETED	151
Enrollment to Catheter Insertion NOT COMPLETED	5
Completed 30-day Visit STARTED	151
Completed 30-day Visit COMPLETED	149
Completed 30-day Visit NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	TactiCath SE Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation.
Enrollment to Catheter Insertion Did not meet inc/exc criteria	4
Enrollment to Catheter Insertion Adverse Event	1
Completed 30-day Visit Withdrawal by Subject	1
Completed 30-day Visit Missed Visit	1

Baseline Characteristics

TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TactiCath SE n=151 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=93 Participants
Age, Categorical >=65 years	76 Participants n=93 Participants
Age, Continuous	65.0 years n=93 Participants
Sex: Female, Male Female	60 Participants n=93 Participants
Sex: Female, Male Male	91 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	125 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	23 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	123 Participants n=93 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=93 Participants
Region of Enrollment United States	101 participants n=93 Participants
Region of Enrollment Italy	12 participants n=93 Participants
Region of Enrollment Australia	22 participants n=93 Participants
Region of Enrollment Germany	21 participants n=93 Participants
BMI	28.0 kg/m^2 STANDARD_DEVIATION 5.0 • n=93 Participants
Coronary Artery Disease	20 Participants n=93 Participants
Heart Failure	4 Participants n=93 Participants
Hypertension	80 Participants n=93 Participants
Diabetes	15 Participants n=93 Participants
Stoke/Transient Ischemic Attack	14 Participants n=93 Participants
Myocardial Infarction	6 Participants n=93 Participants
Obstructive Sleep Apnea	20 Participants n=93 Participants
Structural Heart Disease	5 Participants n=93 Participants
Known Family History of Cardiovascular Disease	81 Participants n=93 Participants
Left Ventricular Ejection Fraction	60.7 % n=93 Participants
Left Atrium Diameter	3.8 centimeters n=93 Participants
Pacemaker or Implantable Cardiac Monitor	19 Participants n=93 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All subjects with device inserted into vasculature and either experienced a primary endpoint event or completed 30 days of follow up.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=149 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Rate of Serious Adverse Events	7 Participants

PRIMARY outcome

Timeframe: 0 days

Population: Effectiveness Population - all subjects with device inserted into vasculature

The primary effectiveness endpoint is acute procedural success, where acute procedural success is defined as confirmation of entrance block in all pulmonary veins

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=151 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Number of Participants With Procedural Success	148 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: During Procedure

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the average power delivered for a case.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=150 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Average Power Delivered	29.0 Watts Interval 26.0 to 32.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: Population includes all subjects with at least some radiofrequency energy delivered.

Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=149 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Population includes all subjects with ablation catheter inserted.

Serious adverse events and adverse events related to the procedure and/or ablation catheter through 30 days post index ablation. This excludes the events identified in the primary safety endpoint.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=151 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Number of Participants Experiencing Serious Adverse Events Within 30 Days Serious AE Related to Device or Procedure	5 Participants
Number of Participants Experiencing Serious Adverse Events Within 30 Days Non-Serious AE Related to Device or Procedure	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Subjects with TactiCath SE inserted into vasculature

Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=151 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Number of Participants Experiencing a Serious Adverse Event Within 1 Year Serious AE Related to Device or Procedure	5 Participants
Number of Participants Experiencing a Serious Adverse Event Within 1 Year Non-Serious AE Related to Device or Procedure	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Includes subjects with the following: * device inserted * RF energy delivered * Had 12M visit or failed endpoint

One-year freedom from AF, defined as freedom from symptomatic AF, atrial flutter (AFL), and atrial tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3-month blanking period.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=133 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
One-year Freedom From AF	108 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: The analysis population included the following subjects: * Device inserted * Radiofrequency energy applied * 12M visit complete or failed endpoint

One-year drug-free success defined as freedom from any AF/AFL/AT lasting at least 30 seconds or any Class I or III AAD after removal from antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=136 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
One-year Drug-free Success From AF	90 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Subset of RF population with EQ-5D-5L data at both baseline and 12M

Changes in EQ-5D-5L utility scores from baseline to follow up at 3, 6, and 12 months Utility scores range from 0 (worst) to 1 (best). A positive change indicates an improvement.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=71 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Changes in EQ-5D-5L Utility Scores Change in EQ-5D-5L Utility from Baseline to 3M	0.044 score on a scale Standard Deviation 0.108
Changes in EQ-5D-5L Utility Scores Change in EQ-5D-5L Utility from Baseline to 6M	0.066 score on a scale Standard Deviation 0.117
Changes in EQ-5D-5L Utility Scores Change in EQ-5D-5L Utility from Baseline to 12M	0.032 score on a scale Standard Deviation 0.158

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Subjects in RF population with available AFEQT data at both baseline and 12M

Changes in AFEQT scores from baseline to follow up at 3, 6, and 12 months AFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=71 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Changes in AFEQT Scores Change from Baseline to 3M	25.8 score on a scale Standard Deviation 23.8
Changes in AFEQT Scores Change from Baseline to 6M	25.2 score on a scale Standard Deviation 21.9
Changes in AFEQT Scores Change from Baseline to 12M	29.1 score on a scale Standard Deviation 23.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Population: Subjects with device inserted and healthcare utilization data reported

Cardiovascular-related health care utilization through 12 months post index ablation Cardiovascular-related health care utilization would include any office visits, tests, hospitalizations, or other interventions outside of routine follow up.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=28 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Health Care Utilization	37 Encounters

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: Subjects from RF population with FTI or LSI data available

Mean force-time integral across lesions for a subject FTI for a lesion is the product of contact force in grams and duration of radiofrequency ablation in seconds. The mean value for this product across all lesions for a subject is then calculated.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=144 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Force Time Integral (FTI)	161.7 gram-seconds Standard Deviation 103.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the average temperature (by lesion) for a case.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=149 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Average Catheter Temperature	33.4 degrees celsius Interval 32.5 to 34.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is whether or not the recommended irrigation flow rate was used for a case.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=150 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Number of Participants With Recommended Irrigation Flow Rate Used During Procedure	140 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the average contact force for a case.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=149 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Contact Force During Procedure	12.1 grams Standard Deviation 4.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the total procedure time for a case.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=150 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Total Procedure Time	159.5 minutes Interval 123.0 to 206.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 Days

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the total ablation time for a case. This is the time from first to last ablation.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=150 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Ablation Time - First to Last Ablation	84.0 minutes Interval 56.0 to 127.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the total fluoroscopy time for a case.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=150 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Fluoroscopy Time	9.0 minutes Interval 5.0 to 16.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the total RF application time for a case.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=149 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Radiofrequency (RF) Application Time	35.7 minutes Interval 28.9 to 51.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: The population includes only subjects with at least some radiofrequency energy delivered.

This outcome is the number of cases using AutoMark.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=150 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Number of Participants Using AutoMark	149 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 days

Population: Subjects from RF population with some LSI data available

Mean lesion index (LSI) across lesions by subject Lesion index is a proprietary score calculated as a function of power, contact force, and duration for a radiofrequency (RF) energy application. Scores start at 0 (no ablation) and do not have an upper limit. Applications must be at least 6 seconds in duration to generate a score. Lesion index is intended to provide feedback to the operator during an RF application.

Outcome measures

Outcome measures
Measure	TactiCath SE - Safety Population n=144 Participants Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation. Includes all subjects with catheter inserted into vasculature.
Lesion Index (LSI)	4.3 units on a scale Standard Deviation 0.8

Adverse Events

TactiCath SE

Serious events: 21 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TactiCath SE n=156 participants at risk Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation.
Cardiac disorders Arrhythmias	4.5% 7/156 • Number of events 8 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Gastrointestinal disorders Atrial-Esophageal Fistula	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Cardiac disorders Cardiac Perforation/Tamponade	1.3% 2/156 • Number of events 2 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Nervous system disorders Cerebrovascular Accident/ Stroke	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Hepatobiliary disorders Cholecystitis	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastroparesis	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Vascular disorders Hypertension	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Gastrointestinal disorders Infections	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Infections and infestations Infections	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Cardiac disorders Pericardial Effusion	1.9% 3/156 • Number of events 3 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Cardiac disorders Pericarditis	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
General disorders Syncope/Dizziness	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Vascular disorders Thromboembolism	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Renal and urinary disorders Urinary Retention	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Blood and lymphatic system disorders Vascular Bleeding/Local Hematomas/Ecchymosis	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Vascular disorders Vascular Damage	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Cardiac disorders Ventricular Tachyarrhythmia	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.

Other adverse events

Other adverse events
Measure	TactiCath SE n=156 participants at risk Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation. TactiCath SE: Ablation to achieve pulmonary vein isolation.
Skin and subcutaneous tissue disorders Allergic Reaction	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Cardiac disorders Chest Pain/Discomfort	3.2% 5/156 • Number of events 5 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Gastrointestinal disorders Epigastric Fullness	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Vascular disorders Hypotension	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Infections and infestations Infections	1.9% 3/156 • Number of events 3 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Renal and urinary disorders Infections	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
General disorders Low Grade Temp	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Cardiac disorders Pericardial Effusion	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Cardiac disorders Pericarditis	3.8% 6/156 • Number of events 6 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Cardiac disorders Syncope/Dizziness	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Vascular disorders Vascular Access Complication	1.3% 2/156 • Number of events 2 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Vascular disorders Vascular Bleeding/Local Hematomas/Ecchymosis	1.9% 3/156 • Number of events 3 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Vascular disorders Volume Overload	1.3% 2/156 • Number of events 2 • 30 days Adverse events include events that are not necessarily related to the device or procedure.
Musculoskeletal and connective tissue disorders Wrist Pain With Swelling And Bruising	0.64% 1/156 • Number of events 1 • 30 days Adverse events include events that are not necessarily related to the device or procedure.

Additional Information

Steven Madej

Abbott

Phone: 651-756-2230

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60