TactiCath® Contact Force Ablation Catheter Study for Atrial Fibrillation Continued Access Protocol



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2014
End Date:October 2015

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Trial Summary
Trial Overview
Inclusion Criteria
A prospective, multicenter, interventional study to collect confirmatory evidence on the
safety and effectiveness of the TactiCath® percutaneous ablation catheter for the treatment
of symptomatic paroxysmal atrial fibrillation using contact force assisted irrigated
radiofrequency ablation.


Inclusion Criteria:

- symptomatic PAF (Paroxysmal Atrial Fibrillation)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(Atrial Fibrillation)

- four or more cardioversions in prior 12 months

- MI (myocardial infarction), CABG (coronary artery bypass graft) or PCI (percutaneous
coronary intervention) within preceding 3 months

- left atrial diameter > 5.0 cm

- LVEF (left ventricular ejection fraction)< 35%

- NYHA (New York Heart Association) class III or IV

- previous left atrial ablation procedure

- previous tricuspid or mitral valve repair surgery
We found this trial at
1
site
Massachusetts General Hospital
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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