- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278953
TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It has been hypothesized that the ability to create durable lesions during radiofrequency (RF) ablation is directly correlated with a reduction in the recurrence of arrhythmia in patients with paroxysmal atrial fibrillation (PAF). Lesion depth is directly correlated with the contact force measured between the the tip of the catheter and the heart tissue. In this study, patients in whom a pulmonary vein isolation procedure has been prescribed for the treatment of PAF will be randomized for treatment with either a device incorporating contact force sensing or one without.
To be included in the study, patients 18 or older must demonstrate a history of atrial fibrillation and will have failed treatment using antiarrhythmic medications. In both study arms, ablation will be performed using an accepted treatment strategy and standard procedures. Patients will receive routine follow-up for 12 months after the procedure, with the addition of ambulatory monitoring to detect the recurrence of episodes of atrial arrhythmia. The study will compare the effectiveness of the procedure in the two arms, and will characterize any differences in safety outcomes primarily related to complications arising from the use of an ablation device and the ablation procedure.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TactiCath
Catheter ablation to treat paroxysmal AF using the TactiCath catheter with contact force capability
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A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
ACTIVE_COMPARATOR: Control
Catheter ablation to treat paroxysmal AF using a catheter with no contact force sensing capability
|
A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
Time Frame: 12 months
|
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.
|
12 months
|
Incidence of Device-related Early-onset Primary Serious Adverse Events
Time Frame: 12 months
|
Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VP-002 527
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