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NCT02310100 · ClinicalTrials.gov registry record · NA

TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study

A NA study of Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices.

Completed
Registry status
NA
Development phase
178
Enrollment target
20
Study locations

NCT02310100: Completed NA study of Paroxysmal Atrial Fibrillation, sponsored by Abbott Medical Devices.

NCT02310100 is a NA study of Paroxysmal Atrial Fibrillation that has completed, run by Abbott Medical Devices. The registered enrollment target is 178 participants, below the 852-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02310100, a NA study of Paroxysmal Atrial Fibrillation, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
NA
Development phase
178 participants
Enrollment target
20
Study locations

Study Summary

A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radiofrequency ablation.

Primary Outcome

Rate of subjects free from symptomatic Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter (AFL), and Atrial Tachycardia (AT) lasting longer than 30 seconds through 9 months of follow-up after a 3 month blanking period compared to a stated performance goal. Procedural failure defined by any of the following events: (1) Documented recurrence of AF/AFL/AT during the 9-month observational period lasting longer than 30 seconds; (2) Repeat ablation following the blanking period; or (3) Use of s new

Interventions

  • DEVICE TactiCath Quartz treatment

Study Locations (20)

California

  • Glendale Memorial Hospital and Health Center - Glendale
  • Regional Cardiology Associates - Sacramento

Massachusetts

  • Massachusetts General Hospital - Boston
  • Brigham and Womens Hospital - Boston

Michigan

  • Cardiology Consultants of East Michigan - Flint
  • Providence Hospital - Southfield

New York

  • Mount Sinai Hospital - New York
  • Stony Brook University Medical Center - Stony Brook

Texas

  • Texas Cardiac Arrhythmia - Austin
  • The Methodist Hospital - Houston

Georgia

  • Emory University Hospital - Atlanta

Kansas

  • Kansas University Medical Center - Kansas City

Kentucky

  • University of Louisville - Louisville

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2015-01-21
Est. Completion 2021-09-17
Phase NA
Abbott Medical Devices

261 total trials

What the finished NCT02310100 record still lists

NCT02310100 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, below the 852-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (79% lower).

The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which TactiCath Quartz treatment is the first listed.

NCT02310100 names 20 study sites across 15 states, led by California, Massachusetts, Michigan.

Frequently Asked Questions

What is clinical trial NCT02310100 about?

NCT02310100 is a clinical study titled "TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Post Approval Study". A prospective, multicenter, interventional study to collect confirmatory evidence on the safety and effectiveness of the TactiCath® percutaneous ablation catheter in the post approval setting for the treatment of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated radio...

What is the current status of trial NCT02310100?

This trial is currently completed. It is a NA study. The enrollment target is 178 participants. The study started on 2015-01-21. Estimated completion is 2021-09-17.

What conditions does trial NCT02310100 study?

This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation.

What interventions are being tested in trial NCT02310100?

The interventions under investigation include: TactiCath Quartz treatment (DEVICE).

Who is sponsoring clinical trial NCT02310100?

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

Where is trial NCT02310100 being conducted?

This trial has 20 study locations across California, Georgia, Kansas, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Paroxysmal Atrial Fibrillation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02310100's enrollment target sits among peer trials

178 16th of 24 higher than 9 of 24 other Paroxysmal Atrial Fibrillation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation 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 NCT02310100, the US trial registry maintained by the National Library of Medicine. NCT02310100 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.