N/A
N=224
Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
Persistent Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03650556 ↗Enrolled (actual)
224
Serious AEs
26.3%
Results posted
Apr 2022
Primary outcome: Primary: Rate of Subjects With a Device and/or Procedure-related SAE. — 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Subjects With a Device and/or Procedure-related SAE. |
7 | — |
| PRIMARY Percent of Subjects Free From Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) Recurrence. |
114 | — |
| SECONDARY Acute Procedural Success |
219 | — |
| SECONDARY 15-month Success Off of Antiarrhythmic Drugs |
89 | — |
| SECONDARY 15 Month Single Procedure Success |
110 | — |
Summary
This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. 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 for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.
Eligibility Criteria
Inclusion Criteria
- Patient must provide written informed consent prior to any clinical investigation related procedure.
- Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7-days and less than 1-year that is documented by (1) a physician's note and (2) a 24-hour Holter within 90-days prior to the procedure, showing continuous AF
- Refractory or intolerant to at least one Class I-IV antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF
- Age 18 years or older
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion Criteria
- Continuous AF > 12 months (longstanding persistent AF)
- Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar
- Any cardiac procedure (surgical or percutaneous) within 90-days prior to the initial procedure
- CABG surgery within the 6-months (180-days) prior to the initial procedure
- Valvular cardiac surgical/percutaneous procedure (i.e. ventriculotomy, valve repair or replacement and/or presence of a prosthetic or mechanical valve)
- Any carotid stenting or endarterectomy
- Documented or known left atrial thrombus on imaging
- Left atrial diameter > 50 mm (parasternal long axis view or by CT)
- Left ventricular ejection fraction 40 kg/m2
- Known sensitivity to contrast media (if needed during the procedure) that cannot be controlled with pre-medication
- Renal failure requiring dialysis
- Vulnerable subject
- History of atriotomy or ventriotomy
- Implanted endocardial left atrial appendage occlusion device
Data sourced from ClinicalTrials.gov (NCT03650556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.