Clinical trial NCT03354663: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: paroxysmal atrial fibrillation
PAF
ablation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-11-28
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of Serious Adverse Events
timeFrame: 30 days
measure: Number of Participants With Procedural Success
timeFrame: 0 days
Secondary outcomes:
Other outcomes:
measure: Average Power Delivered
timeFrame: During Procedure
measure: Index Cases Achieving ≥ 90% Lesions With ≥ 10 Contact Force
timeFrame: 0 days
measure: Number of Participants Experiencing Serious Adverse Events Within 30 Days
timeFrame: 30 days
measure: Number of Participants Experiencing a Serious Adverse Event Within 1 Year
timeFrame: 1 year
measure: One-year Freedom From AF
timeFrame: 1 year
measure: One-year Drug-free Success From AF
timeFrame: 1 year
measure: Changes in EQ-5D-5L Utility Scores
timeFrame: 1 year
measure: Changes in AFEQT Scores
timeFrame: 1 year
measure: Health Care Utilization
timeFrame: 1 year
measure: Force Time Integral (FTI)
timeFrame: 0 days
measure: Average Catheter Temperature
timeFrame: 0 days
measure: Number of Participants With Recommended Irrigation Flow Rate Used During Procedure
timeFrame: 0 days
measure: Contact Force During Procedure
timeFrame: 0 days
measure: Total Procedure Time
timeFrame: 0 days
measure: Ablation Time - First to Last Ablation
timeFrame: 0 Days
measure: Fluoroscopy Time
timeFrame: 0 days
measure: Radiofrequency (RF) Application Time
timeFrame: 0 days
measure: Number of Participants Using AutoMark
timeFrame: 0 days
measure: Lesion Index (LSI)
timeFrame: 0 days
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Health
state: California
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, P.C.
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Adelaide
country: Australia
facility: Ashford Hospital
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital - City Campus
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
state: Saxony
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Milan
country: Italy
facility: Ospedale San Raffaele
state: Lombardy
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
affiliation: Abbott
name: Kristin Ruffner, PhD MBA
role: STUDY_DIRECTOR
References: