TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation (TactiSense)

• ClinicalTrials.gov Identifier: NCT03354663
• Recruitment Status: Completed
• First Posted: November 28, 2017
• Results First Posted: August 20, 2019
• Last Update Posted: August 7, 2020
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Tracking Information

• First Submitted Date: November 17, 2017
• First Posted Date: November 28, 2017
• Results First Submitted Date: August 1, 2019
• Results First Posted Date: August 20, 2019
• Last Update Posted Date: August 7, 2020
• Actual Study Start Date: December 11, 2017
• Actual Primary Completion Date: August 2, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 14, 2020)

• Rate of Serious Adverse Events [ Time Frame: 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
  • 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.
• Number of Participants With Procedural Success [ Time Frame: 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

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: July 24, 2020)

• Average Power Delivered [ Time Frame: During Procedure ]
  This outcome is the average power delivered for a case.
• Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force [ Time Frame: 0 days ]
  Proportion of index cases achieving ≥ 90% lesions with ≥10g contact force
• Number of Participants Experiencing Serious Adverse Events Within 30 Days [ Time Frame: 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.
• Number of Participants Experiencing a Serious Adverse Event Within 1 Year [ Time Frame: 1 year ]
  Serious adverse events and adverse events related to the procedure and/or ablation catheter through 1 year post index ablation
• One-year Freedom From AF [ Time Frame: 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.
• One-year Drug-free Success From AF [ Time Frame: 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.
• Changes in EQ-5D-5L Utility Scores [ Time Frame: 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.
• Changes in AFEQT Scores [ Time Frame: 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.
• Health Care Utilization [ Time Frame: 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.
• Force Time Integral (FTI) [ Time Frame: 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.
• Average Catheter Temperature [ Time Frame: 0 days ]
  This outcome is the average temperature (by lesion) for a case.
• Number of Participants With Recommended Irrigation Flow Rate Used During Procedure [ Time Frame: 0 days ]
  This outcome is whether or not the recommended irrigation flow rate was used for a case.
• Contact Force During Procedure [ Time Frame: 0 days ]
  This outcome is the average contact force for a case.
• Total Procedure Time [ Time Frame: 0 days ]
  This outcome is the total procedure time for a case.
• Ablation Time - First to Last Ablation [ Time Frame: 0 Days ]
  This outcome is the total ablation time for a case. This is the time from first to last ablation.
• Fluoroscopy Time [ Time Frame: 0 days ]
  This outcome is the total fluoroscopy time for a case.
• Radiofrequency (RF) Application Time [ Time Frame: 0 days ]
  This outcome is the total RF application time for a case.
• Number of Participants Using AutoMark [ Time Frame: 0 days ]
  This outcome is the number of cases using AutoMark.
• Lesion Index (LSI) [ Time Frame: 0 days ]
  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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
• Official Title: Multi-Center Acute Safety Trial of TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the Treatment of Drug Refractory Recurrent Symptomatic Paroxysmal Atrial Fibrillation
• Brief Summary: 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.
• Detailed Description: This is a prospective, multi-center, single-arm clinical trial to demonstrate the acute safety and effectiveness of the TactiCath SE catheter for the treatment of PAF against a performance goal. One hundred fifty six (156) subjects will be enrolled at up to 35 investigational sites in the US, Europe, and Australia. Only sites that enroll at least one subject will be part of the analysis population. No center may contribute more than 20% of the total number of enrollments without sponsor pre-approval to exceed this proportion and at least 50% of subjects must be from the United States.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Paroxysmal Atrial Fibrillation

Intervention

Device: TactiCath SE

Ablation to achieve pulmonary vein isolation.

Study Arms

Experimental: TactiCath SE

Catheter ablation with the TactiCath SE ablation catheter to achieve pulmonary vein isolation.

Intervention: Device: TactiCath SE

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 27, 2018): 156
• Original Enrollment: Not Provided
• Actual Study Completion Date: October 30, 2019
• Actual Primary Completion Date: August 2, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Plans to undergo a catheter ablation procedure due to symptomatic PAF that is refractory or intolerant to at least one Class I or III antiarrhythmic drug
• Physician's note indicating recurrent self-terminating AF
• One electrocardiographically documented AF episode within 6 months prior to the index ablation procedure
• At least 18 years of age
• Able and willing to comply with all trial requirements
• Informed of the nature of the trial, agreed to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

Exclusion Criteria:

• Persistent or long-standing persistent atrial fibrillation (AF)
• Four or more cardioversions in the past 12 months
• Active systemic infection
• Known presence of cardiac thrombus
• Implanted with implantable cardiac defibrillator (ICD)
• Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, and other major surgical procedures in the preceding 3 months
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 3 months
• Left atrial diameter > 5.0 cm
• Left ventricular ejection fraction < 35%
• New York Heart Association (NYHA) class III or IV
• Previous left atrial surgical or catheter ablation procedure
• Left atrial surgical procedure or incision with resulting scar
• Previous tricuspid or mitral valve replacement or repair
• Heart disease in which corrective surgery is anticipated within 6 months
• Bleeding diathesis or suspected procoagulant state
• Contraindication to long term antithromboembolic therapy
• Presence of any condition that precludes appropriate vascular access
• Renal failure requiring dialysis
• Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
• Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
• Pregnant or nursing
• Presence of other anatomic or comorbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results
• Patient is currently participating in another clinical trial or has participated in a clinical trial within 30 days prior to screening that may interfere with this clinical trial
• Patient is unlikely to survive the protocol follow up period of 12 months
• Body mass index > 40 kg/m2
• Vulnerable subject

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Germany, Italy, United States

Administrative Information

• NCT Number: NCT03354663
• Other Study ID Numbers: SJM-CIP-10216
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

• IPD Sharing Statement: Not Provided
• Responsible Party: Abbott Medical Devices
• Study Sponsor: Abbott Medical Devices
• Collaborators: Not Provided

Investigators

• Study Director: Kristin Ruffner, PhD MBA; Abbott

• PRS Account: Abbott Medical Devices
• Verification Date: July 2020