N/A
N=156
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03354663 ↗Enrolled (actual)
156
Serious AEs
13.5%
Results posted
Aug 2019
Primary outcome: Primary: Rate of Serious Adverse Events — 7 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TactiCath SE (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Serious Adverse Events |
7 | <0.0001 sig |
| PRIMARY Number of Participants With Procedural Success |
148 | 0.0001 sig |
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.
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 40 kg/m2
- Vulnerable subject
Data sourced from ClinicalTrials.gov (NCT03354663). 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.