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NCT01278953 · ClinicalTrials.gov registry record · NA
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT01278953: Completed NA study, sponsored by Abbott Medical Devices.
NCT01278953 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01278953, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
Study Summary
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied. A second phase of the study will treat up to 50 non-randomized subjects with a new version of the device under the same protocol.
Primary Outcome
Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.
Interventions
- DEVICE Catheter ablation to treat paroxysmal atrial fibrillation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-09 |
| Phase | NA |
What the finished NCT01278953 record still lists
NCT01278953 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Catheter ablation to treat paroxysmal atrial fibrillation is the first listed.
NCT01278953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01278953 about?
NCT01278953 is a clinical study titled "TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation". The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing ...
What is the current status of trial NCT01278953?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2011-01. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01278953?
The interventions under investigation include: Catheter ablation to treat paroxysmal atrial fibrillation (DEVICE).
Who is sponsoring clinical trial NCT01278953?
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 NCT01278953's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 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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