A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation
This trial is active, not recruiting.
|Conditions||atrial fibrillation, burden of atrial fibrillation|
|Treatments||contact force during ablation, standard ablation procedure|
|Sponsor||University of Aarhus|
|Start date||February 2012|
|End date||September 2014|
|Trial size||50 participants|
|Trial identifier||NCT01538277, CFC-PVAI|
The knowledge of the real-time contact force leads to a greater reduction in atrial fibrillation burden after pulmonary vein antrum isolation.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Reduction in atrial fibrillation burden (after 3 months blanking period) in comparison with the period prior to ablation in the absence of antiarrhythmic drugs
time frame: 12 month follow after the RFA treatment
Contact Force distribution during procedure (g/cm2) Post ablation A-fib burden(% of time in atrial fibrillation) Complications (number) Time spent on RFA of each pulmonary vein (min.) Reconnected pulmonary veins during adenosine/isoprenaline
time frame: 12 month follow up after the RFA treatment
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients <75 years of age with atrial fibrillation who have had at least two episodes of symptomatic paroxysmal or short-lasting persistent atrial fibrillation in the foregoing 12 months undergoing the first pulmonary vein antrum isolation can be included. - Patients having also persistent episodes of atrial fibrillation of shorter duration (the longest atrial fibrillation episode 3 months) on top of paroxysmal episodes will be included Exclusion Criteria: - Contraindication to anticoagulation treatment with vitamin K antagonists Amiodarone therapy Expected surgery for structural heart disease within the follow-up period Significant mitral valve disease NYHA III-IV Left ventricular ejection fraction < 35% Left atrial diameter > 5 cm Secondary atrial fibrillation (e.g. post-surgery, infections, hyperthyroidism) Age < 18 years
|Official title||A Pilot Study of a Contact Force Catheter for Pulmonary Vein Antrum Isolation (CFC-PVAI)|
|Description||A randomized controlled study comparing pulmonary vein antrum isolation with and without the knowledge of the real-time contact force. In both groups, a catheter, which is able to measure contact force (SmartTouch, ThermoCool catheter, Biosense Webster) will be used. In the control group, the operator will be blinded to the measured contact-force. In all patients, the ablation will be guided by a circumferential mapping catheter (Lasso, Biosense Webster), CARTO 3 mapping system and ablation of adenosine-induced reconnection will be performed in all patients. Follow-up will be performed by continuous monitoring using an implantable loop recorder (Reveal XT, Medtronic Inc, Minneapolis, Minn)|
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