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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 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 300 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01278953
The ClinicalTrials.gov registry entry for NCT01278953 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Catheter ablation to treat paroxysmal atrial fibrillation is the first listed.
NCT01278953 reports 0 study locations.
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.
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