Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
NCT ID: NCT01278953
Sponsor Protocol Number: VP-002 527
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
- 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
- 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
Publications are currently not available