Paroxysmal or persistent atrial fibrillation
Conditions
Interventions
Study Design: This is a nonrandomized, non-blinded, prospective pilot study. Thirty subjects with symptomatic paroxysmal or persistent AF will be enrolled. All subjects will receive pulmonary vein (
Sponsors
Toray Industries, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Enrolled subjects must meet all of the following inclusion criteria: (1)Subject is =20 and <75 years old. (2)Subject has been diagnosed with symptomatic paroxysmal or persistent AF that meets all of the following criteria: i)At least two AF (paroxysmal AF) or one AF (persistent AF) episodes in the 6 months preceding study enrollment have occurred, and at least one documented AF episode via ECG, event monitor, or Holter monitor in the six months preceding study enrollment has occurred, and ii)Any paroxysmal AF episode must spontaneously terminate within seven days of onset, or iii)Any persistent AF episode must spontaneously terminate within one year of onset. (3)Subject has failed to respond to or is intolerant of at least one Class I, II, III or IV AAD.("Intolerant " is defined as having suffered a clinically significant adverse drug effect). (4)Subject is able and willing to provide informed consent.
Exclusion criteria
Exclusion criteria: left atrium >= 50 mm. amiodarone within six months. undergone previous LA ablation or surgical treatment for AF. LVEF< 35%. NYHA Class III or IV. history of MI or unstable angina. non-revascularized left main or >= 3-vessel coronary artery disease. severe mitral valve regurgitation or stenosis and is not an appropriate candidate for valvular intervention. left atrial thrombus. left atrial appendage occlusion device. severe obstructive carotid artery disease. hypertrophic cardiomyopathy with severe left ventricular outflow tract obstructions. severe pulmonary arterial hypertension. artificial heart valve. pacemaker and or ICD. history of cerebrovascular disease. severe aortic stenosis. IVC filter. DVT. significant renal failure. known history of a bleeding disorder. unable to take warfarin. abnormal thyroid function. allergy to iodine or iodine type of contrast media. active malignancy of any kind. pregnant or lactating. participated in another clinical research study within 3 months. judged to be unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoints (1)The occurrence of Major Complications will be assessed through the 6-month follow-up visit. Major Complications are defined as: - An SAE within seven days of the post ablation procedure; - Severe PV stenosis (>70%) or esophageal fistula that occurs any time after the ablation procedure; - Mild (<50%) or moderate (50-70%) PV stenosis that occurs any time after the ablation procedure and meets one of the following criteria: --Requires an invasive intervention, such as PV stenting or --Results in clinically significant symptoms. Primary Efficacy Endpoints (1)The rate of acute procedural success will be calculated. Acute procedural success is defined as evidence of PV electrical potential elimination (PV electrogram amplitude < 0.1 mV) or LA-PV (left atrial-pulmonary vein) dissociation of all treated pulmonary veins at the time of procedure. (2)The rate of long-term success through 12-month follow-up. Long-term success is defined as freedom from any electrocardiographic evidence of an AF episode >= 30 seconds' duration from the conclusion of the blanking period through the 6-month follow-up visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Safety Endpoints (1)The occurrence of Minor complications (2)The occurrence of all non-serious adverse events and serious adverse events (3)The occurrence of Major Complications will be assessed through the 12-month follow-up visit Secondary Efficacy Endpoints (1)The rate of long-term success through 12-month follow-up. (Freedom from any electrocardiographic evidence of an AF episode >= 30 seconds' duration from the conclusion of the blanking period through the 12-month follow-up visit.) (2)QOL (SF-36) | — |
Countries
Japan
Outcome results
None listed