TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation

Completed · Not applicable

Conditions studied: Paroxysmal Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT01278953

Run by

Abbott Medical Devices

People needed

300

Starts

2011-01-01

Expected to finish

2015-09-01

Last updated by the study team

2019-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug
• minimum one documented PAF episode >30 sec duration within prior 12 months
• minimum three PAF episodes during prior 12 months
• 18 years or older

You may not qualify if…

• persistent or long-standing persistent AF
• four or more cardioversions in prior 12 months
• MI, CABG or PCI within preceding 3 months
• left atrial diameter > 5.0 cm
• LVEF < 35%
• NYHA class III or IV
• previous left atrial ablation procedure
• previous tricuspid or mitral valve repair surgery

Where it is running

• Mount Sinai Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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