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New heart pacing technique aims to boost therapy for heart failure

NCT ID NCT07531368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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