TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
| Status: | Completed |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/23/2019 |
| Start Date: | January 2011 |
| End Date: | September 2015 |
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.
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.
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.
(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.
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
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