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NCT03650556 · ClinicalTrials.gov registry record · NA

Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation

A NA study, sponsored by Abbott Medical Devices.

Completed
Registry status
NA
Development phase
224
Enrollment target

NCT03650556: Completed NA study, sponsored by Abbott Medical Devices.

NCT03650556 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 224 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03650556, a NA study, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
NA
Development phase
224 participants
Enrollment target

Study 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.

Primary Outcome

Rate of subjects with a device and/or procedure-related SAE with onset within 7-days of any ablation procedure that used the investigational device.

Interventions

  • DEVICE TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2018-09-28
Est. Completion 2021-01-11
Phase NA
Abbott Medical Devices

261 total trials

What the finished NCT03650556 record still lists

NCT03650556 is an interventional study that assigns participants to a tested intervention. The registered 224 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 (84% lower).

The record links to 0 conditions, and to 1 intervention - of which TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is the first listed.

NCT03650556 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03650556 about?

NCT03650556 is a clinical study titled "Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation". 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 fibr...

What is the current status of trial NCT03650556?

This trial is currently completed. It is a NA study. The enrollment target is 224 participants. The study started on 2018-09-28. Estimated completion is 2021-01-11.

What interventions are being tested in trial NCT03650556?

The interventions under investigation include: TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (DEVICE).

Who is sponsoring clinical trial NCT03650556?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03650556's enrollment target sits among peer trials

224 478th of 2000 higher than 1,520 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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Source: ClinicalTrials.gov NCT03650556, the US trial registry maintained by the National Library of Medicine. NCT03650556 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.