Tiny study tests ablation for tough heart condition – but ends early
NCT ID NCT04282850
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study compared a heart ablation procedure (pulmonary vein isolation) to standard medications for managing atrial fibrillation in people with heart failure with preserved ejection fraction. Only 13 participants were enrolled before the study was terminated early. The main goal was to see if ablation could reduce the amount of time spent in atrial fibrillation and improve exercise capacity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pulmonary vein isolation (a heart ablation procedure)
- What this could lead to
- If successful, this could show that ablation improves exercise capacity and reduces AF burden better than medications alone for people with both atrial fibrillation and heart failure with preserved ejection fraction.
- What could go wrong
- This was a very small pilot study (13 participants) that was terminated early, so results are limited and may not apply to larger populations. The procedure also carries risks like bleeding, infection, or heart rhythm complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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13 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Feb 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 by septal thickness or posterior wall thickness \> 1.0 cm * And at least one of the following: * A heart failure hospitalization lasting over 12 hours and including intravenous diuretics at a healthcare facility within 12 months prior to the enrollment visit. * An elevated pro-brain natriuretic peptide (BNP) (\>100 pg/mL, or N-terminal pro b-type natriuretic peptide (NT-proBNP)\>300 pg/mL) * Hemodynamic testing consistent with HFpEF physiology including pulmonary capillary wedge pressure (PCWP) (or LVEDP) ≥ 15 mmHg. Exclusion Criteria: * Previous left heart ablation procedure for AF * Contraindication to chronic anticoagulation therapy or heparin * Longstanding atrial fibrillation, defined here as greater than 3 years of persistent atrial fibrillation * Severe left atrial dilatation, with LA length \> 6.0 cm, optimally from parasternal long view * Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent). * Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment. * Planned cardiovascular intervention * Listed for heart transplant * Cardiac assist device implanted or need for mechanical hemodynamic support or inpatient admission * Life expectancy less than 1 year * Uncontrolled hypertension, defined as resting systolic blood pressure \>190 and/or resting diastolic pressure\>110 * Chronic Kidney Disease (CKD) stage 4-5 (GFR\<25 ml/min/1.73m2), or on hemodialysis * Cardiac diagnosis in addition to or other than HFpEF: * Active myocarditis * Hypertrophic obstructive cardiomyopathy * Severe valvular disease * Restrictive or constrictive cardiomyopathy, including known amyloidosis, sarcoidosis, hemochromatosis * Complex congenital heart disease * Constrictive pericarditis * Severe pulmonary hypertension (RVSP \> 60 mmHg), not secondary to HFpEF * Non-cardiac pulmonary edema * Clinical evidence of digoxin toxicity * Sepsis * Inability to comply with planned study procedures * Pregnancy or nursing mothers * Uncontrolled hypothyroidism or hyperthyroidism * BMI of \>65 kg/m2
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Inova Heart and Vascular Institute
Fairfax, Virginia, 22031, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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