New pacing technique could help heart failure patients with electrical delay
NCT ID NCT07547306
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a special pacing method for people with heart failure and a type of heart block. The goal is to see if pacing a specific area of the heart can improve heart function and quality of life. About 120 adults with heart failure and reduced pumping ability will participate. The study compares results when the pacing is on versus off.
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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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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- 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 years and older
- 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: 1. Age ≥18 years at the time of screening. 2. A documented diagnosis of chronic heart failure with New York Heart Association (NYHA) class II-IV. 3. Left ventricular ejection fraction (LVEF) ≤40%, documented by an imaging study performed within 12 months prior to screening. 4. Receiving optimized guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF), unless contraindicated or not tolerated: * Participants receiving ongoing treatment must be on a stable regimen for at least 1 month prior to screening (except for diuretics). * Most patients with heart failure require diuretics for volume control, and dose adjustments may be made based on clinical status, including symptoms, signs, and body weight. Each participant should receive individualized diuretic therapy to maintain optimal volume status. 5. Presence of interatrial block (IAB), defined as a P-wave duration ≥120 ms on a 12-lead electrocardiogram or ECG recording device. 6. An indication for dual-chamber implantable cardioverter-defibrillator (ICD) implantation for primary or secondary prevention. 7. NT-proBNP measured within 3 months prior to randomization meeting one of the following criteria: * NT-proBNP \>300 pg/mL Exclusion Criteria: 1. Non-paroxysmal AF. 2. Uncontrolled tachyarrhythmia. 3. Sinus bradycardia requiring continuous atrial pacing or atrioventricular block requiring ventricular pacing. 4. Acute decompensated heart failure at the time of screening or hospitalization for worsening heart failure within 4 weeks prior to enrollment. 5. Moderate to severe primary valvular heart disease (functional mitral regurgitation or tricuspid regurgitation is not an exclusion criterion). 6. Prior mechanical tricuspid valve replacement. 7. Coronary revascularization (PCI or CABG) or valve surgery/repair performed within 12 weeks prior to enrollment, or planned after randomization. 8. Obstructive hypertrophic cardiomyopathy. 9. Infiltrative cardiomyopathy, including but not limited to amyloidosis, sarcoidosis, or Fabry disease. 10. An indication for cardiac resynchronization therapy (CRT). 11. Chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m² calculated using the CKD-EPI equation. 12. Chronic liver disease, defined as alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase \>3 times the upper limit of normal at screening. 13. Severe pulmonary disease, such as cor pulmonale or irreversible lung disease requiring inhaled therapy or long-term oxygen therapy. 14. Uncontrolled hypertension, defined as a mean blood pressure \>140/90 mmHg based on outpatient clinic measurements or home blood pressure recordings within the previous 30 days, or ongoing up-titration of antihypertensive medications. 15. Pregnant or breastfeeding women, or women planning pregnancy or breastfeeding during the study period. 16. Active malignancy requiring treatment at the time of screening. 17. Life expectancy \<12 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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