Ablation Versus Medical Management of Atrial Fibrillation in HFpEF (NCT04282850) | Clinical Trial Compass
TerminatedNot Applicable
Ablation Versus Medical Management of Atrial Fibrillation in HFpEF
Stopped: enrollment was not keeping up with technology advancements. PI felt the data would not be pertinent
United States13 participantsStarted 2023-07-10
Plain-language summary
This is a prospective non-blinded randomized control pilot study comparing the effect of pulmonary vein isolation against medical management of atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction (HFpEF).
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* between 18 to 90 years of age, male or female
* Left Ventricular Ejection Fraction (LVEF) \> 50% by echocardiogram during routine screening or within 12 months prior to enrollment day.
* Symptoms of heart failure requiring treatment with diuretic therapy for at least 30 days preceding enrollment.
* Symptomatic paroxysmal or persistent atrial fibrillation.
* Paroxysmal atrial fibrillation defined as recurrent AF (at least 2 episodes) that terminated spontaneously within 7 days
* Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion
* Included within the category of persistent AF is "long-standing persistent AF" defined as continuous AF of greater than 1 year in duration
* AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter monitor, Loop recorder, memory of the implanted device, or any suitable device.
* Current symptoms of heart failure (NYHA II-IV) at the enrollment visit (Visit 1)
* Structural heart disease evidenced by one or both of the following echocardiographic findings (done during the transthoracic echocardiography (TTE) within 6 months of enrollment)
* Left atrial enlargement (LAE) defined as LA width \> 3.8 cm or LA length \> 5.0 cm, or LA area \> 20 cm2 or LA volume \> 55 mL or LA volume index \> 29 ml/m2. (of note, LA length greater than 6.0 cm will be excluded)
* Left ventricular hypertrophy (LVH) defined …
What they're measuring
1
Change in AF burden as assessed by difference in percentage of time an individual is in AF
Timeframe: 3, 6, 9, and 12 months from intervention