NCT03354663: TactiSense

TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation

Completed NA Results posted Last updated 11 October 2023

What this trial tests

NA trial testing TactiCath SE in Paroxysmal Atrial Fibrillation in 156 participants. Completed in 30 October 2019.

Timeline

11 December 2017

Primary endpoint
2 August 2018

30 October 2019

Quick facts

Lead sponsor	Abbott Medical Devices
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	156
Start date	11 December 2017
Primary completion	2 August 2018
Estimated completion	30 October 2019
Sites	21 locations across Italy, Germany, United States, Australia

Drugs / interventions tested

• TactiCath SE

Conditions studied

• Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Serious Adverse Events Primary · 30 days

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 * Pul

Group	Value	95% CI
TactiCath SE - Safety Population	7

Number of Participants With Procedural Success Primary · 0 days

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

Group	Value	95% CI
TactiCath SE	148

Average Power Delivered Secondary · During Procedure

This outcome is the average power delivered for a case.

Group	Value	95% CI
RF Population	29.0	26.0 – 32.0

Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force Secondary · 0 days

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

Group	Value	95% CI
RF Population	5

Number of Participants Experiencing Serious Adverse Events Within 30 Days Secondary · 30 days

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.

Serious AE Related to Device or Procedure

Group	Value	95% CI
TactiCath SE	5

Non-Serious AE Related to Device or Procedure

Group	Value	95% CI
TactiCath SE	23

Number of Participants Experiencing a Serious Adverse Event Within 1 Year Secondary · 1 year

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

Serious AE Related to Device or Procedure

Group	Value	95% CI
TactiCath SE	5

Non-Serious AE Related to Device or Procedure

Group	Value	95% CI
TactiCath SE	23

One-year Freedom From AF Secondary · 1 year

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.

Group	Value	95% CI
TactiCath SE	108

One-year Drug-free Success From AF Secondary · 1 year

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.

Group	Value	95% CI
TactiCath SE Drug-Free Success Population	90

Changes in EQ-5D-5L Utility Scores Secondary · 1 year

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.

Change in EQ-5D-5L Utility from Baseline to 3M

Group	Value	95% CI
RF Population	0.044	± 0.108

Change in EQ-5D-5L Utility from Baseline to 6M

Group	Value	95% CI
RF Population	0.066	± 0.117

Change in EQ-5D-5L Utility from Baseline to 12M

Group	Value	95% CI
RF Population	0.032	± 0.158

Changes in AFEQT Scores Secondary · 1 year

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.

Change from Baseline to 3M

Group	Value	95% CI
RF Population	25.8	± 23.8

Change from Baseline to 6M

Group	Value	95% CI
RF Population	25.2	± 21.9

Change from Baseline to 12M

Group	Value	95% CI
RF Population	29.1	± 23.0

Health Care Utilization Secondary · 1 year

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.

Group	Value	95% CI
TactiCath SE	37

Force Time Integral (FTI) Secondary · 0 days

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.

Group	Value	95% CI
RF Population	161.7	± 103.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TactiCath SE

Serious: 21/156 (13%)

Deaths: 0/156

Serious adverse events (17 terms)

Reaction	System	TactiCath SE
Arrhythmias	Cardiac disorders	—
Pericardial Effusion	Cardiac disorders	—
Cardiac Perforation/Tamponade	Cardiac disorders	—
Atrial-Esophageal Fistula	Gastrointestinal disorders	—
Cerebrovascular Accident/ Stroke	Nervous system disorders	—
Cholecystitis	Hepatobiliary disorders	—
Gastroparesis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Hypertension	Vascular disorders	—
Infections	Gastrointestinal disorders	—
Infections	Infections and infestations	—
Pericarditis	Cardiac disorders	—
Syncope/Dizziness	General disorders	—
Thromboembolism	Vascular disorders	—
Urinary Retention	Renal and urinary disorders	—
Vascular Bleeding/Local Hematomas/Ecchymosis	Blood and lymphatic system disorders	—
Vascular Damage	Vascular disorders	—
Ventricular Tachyarrhythmia	Cardiac disorders	—

Other adverse events (14 terms — click to expand)

Reaction	System	TactiCath SE
Pericarditis	Cardiac disorders	—
Chest Pain/Discomfort	Cardiac disorders	—
Infections	Infections and infestations	—
Vascular Bleeding/Local Hematomas/Ecchymosis	Vascular disorders	—
Vascular Access Complication	Vascular disorders	—
Volume Overload	Vascular disorders	—
Allergic Reaction	Skin and subcutaneous tissue disorders	—
Epigastric Fullness	Gastrointestinal disorders	—
Hypotension	Vascular disorders	—
Infections	Renal and urinary disorders	—
Low Grade Temp	General disorders	—
Pericardial Effusion	Cardiac disorders	—
Syncope/Dizziness	Cardiac disorders	—
Wrist Pain With Swelling And Bruising	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Arrhythmias, Pericardial Effusion, Cardiac Perforation/Tamponade, Atrial-Esophageal Fistula, Cerebrovascular Accident/ Stroke, Cholecystitis, Gastroparesis, Hypertension.

Data from ClinicalTrials.gov NCT03354663 adverse events section.

Sponsor's own description

This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter in the United States. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. This clinical investigation is sponsored by Abbott.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.