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NCT03354663 · ClinicalTrials.gov registry record · NA
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 156
- Enrollment target
NCT03354663: Completed NA study, sponsored by Abbott Medical Devices.
NCT03354663 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 156 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03354663, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 156 participants
- Enrollment target
Study 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.
Primary Outcome
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 * Gastropar
Interventions
- DEVICE TactiCath SE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2017-12-11 |
| Est. Completion | 2019-10-30 |
| Phase | NA |
What the finished NCT03354663 record still lists
NCT03354663 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which TactiCath SE is the first listed.
NCT03354663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03354663 about?
NCT03354663 is a clinical study titled "TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation". 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 inv...
What is the current status of trial NCT03354663?
This trial is currently completed. It is a NA study. The enrollment target is 156 participants. The study started on 2017-12-11. Estimated completion is 2019-10-30.
What interventions are being tested in trial NCT03354663?
The interventions under investigation include: TactiCath SE (DEVICE).
Who is sponsoring clinical trial NCT03354663?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03354663's enrollment target sits among peer trials
156 656th of 2000 higher than 1,345 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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