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New heart pacing technique aims to boost therapy for heart failure
NCT ID NCT07531368
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new method to guide where a pacing lead is placed in the heart's upper chambers during cardiac resynchronization therapy for heart failure. Researchers will use a special catheter to map electrical signals and target a specific area called Bachmann's bundle. The trial involves 40 adults with heart failure and will compare this guided approach to standard placement, checking success rates and safety over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- atrial lead placement guided by coronary sinus mapping
- What this could lead to
- If successful, this could make cardiac resynchronization therapy more effective for heart failure patients by improving how the heart's upper chambers are paced.
- What could go wrong
- This is a small, early-stage study with only 40 participants, so results may not apply to all patients. The procedure involves risks like lead repositioning or complications from the mapping catheter.
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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About 40 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 2027
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 Sinus rhythm * 2 Left ventricular ejection fraction (LVEF) ≤ 35%, QRS duration ≥ 150 ms; or 130 ms \< QRS duration \< 150 ms with left bundle branch block (LBBB) morphology * 3 LVEF ≤ 40% with expected ventricular pacing \> 20% * 4 New York Heart Association (NYHA) class II, III, or ambulatory IV symptoms * 5 After at least 3 months of guideline-directed medical therapy (GDMT) optimization * 6 Age ≥ 18 years * 7 Signed informed consent form, good compliance, and ability to complete study follow-up Exclusion Criteria: * Prior implantation of CRT/ICD/pacemaker: Previous implantation of any cardiac implantable electronic device (CIED), except for patients in Group C requiring device replacement/upgrade * Non-compliance with GDMT requirements: Failure to receive or inability to tolerate optimized medical therapy * Inappropriate QRS duration: QRS \< 130 ms (Groups A and C) * Excessive improvement in LVEF: Recent (within 3 months) LVEF \> 40% with clear evidence of normalized cardiac function * Severe valvular heart disease: Severe aortic stenosis/regurgitation, mitral stenosis requiring surgical or interventional treatment * Recent cardiovascular events: Acute myocardial infarction, stroke/transient ischemic attack (TIA) within 3 months before enrollment; coronary revascularization (PCI or CABG) within 6 months before enrollment * Unstable angina pectoris: Canadian Cardiovascular Society (CCS) class III-IV * Severe arrhythmias: History of sustained ventricular tachycardia or ventricular fibrillation (without ICD protection) * Types of cardiomyopathy: Hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy (ARVC), and other specific etiologies not suitable for CRT * Severe renal insufficiency: Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m² or uncontrolled renal failure * Severe liver dysfunction: Child-Pugh class C * Active infection: Including sepsis, infective endocarditis, etc. * Malignant tumor: Advanced malignant tumor with expected survival \< 12 months * Pregnancy or lactation: Positive pregnancy test in women of childbearing age or planned pregnancy * Cognitive impairment: Inability to provide informed consent or follow the study protocol * Mental illness: Severe mental disorders affecting treatment compliance * Geographical restrictions: Inability to maintain contact or return to the medical center regularly during follow-up * Venous access disorders: Inability to implant CRT via venous route (e.g., bilateral subclavian vein occlusion) * Contralateral device: Implanted contralateral CIED leading to risk of lead crossing or interference * Participation in other interventional clinical trials, or other conditions deemed unsuitable for enrollment by the investigator
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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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
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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