Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure
Key facts
- Who runs it
- Region Skane
- Where
- Sweden1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 2 people enrolled
- Started
- 1 Sept 2021
- Ended
- 27 Feb 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Temporary His bundle pacing
- Record updated
- 28 February 2025
- Why it stopped
- Logistic challenges
Who can take part
- Age
- 18 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age >18 years
- Native QRS-duration >130 ms and a left bundle branch block or previous His-ablation
- Heart failure in New York Heart Association functional class II-IV
- Echocardiographic non-responder to ongoing CRT defined as <15% reduction in LVESV compared to pre-CRT examination
- Clinical non-responder to ongoing CRT, defined as lack of subjective improvement after CRT
- Signed informed consent
Who cannot take part
- Known access site problems in vena jugularis interna dx or sin
- Not able to perform supine cycling
- Presence of severe tricuspid regurgitation
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is indicated for patients with low ejection fraction and persistent symptoms of heart failure despite medical therapy and a wide QRS-complex, preferably with a left bundle branch block. Unfortunately, up to 40 % receiving CRT do not respond with subjective improvement or improved left ventricular ejection fraction from the treatment.
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There are few therapeutic alternatives in patients not responding to CRT with BVP, and the potential to improve cardiac function in these patients could make a large difference in terms of life quality and prognosis.
His-bundle pacing (HBP) can be a suitable alternative, but is likely not possible in all patients with failed CRT. Furthermore, upgrading to HBP does require a surgical procedure and therefore exposes the patients to risk of complications (e.g. infection of the device). Therefore, early identification of the patients who are likely to benefit from an upgrade to HBP would be beneficial.
This study aims to evaluate if patients with failed CRT treatment will benefit from hemodynamic improvement if they are treated with temporary HBP, without opening the device-pocket, and exposing the existing pacemaker-device to a risk of infection. A temporary pacemaker lead and pacing sheath will be used, and placed in the heart via a blood vessel on the right side of neck, using local anaesthesia. Acute effects on the pump function of the heart will be measured during rest and during supine bicycle test (the equivalent of moderate physical activity). Factors associated with a beneficial effect will be evaluated on a group basis.
If the individual patient experiences an improvement of cardiac function during the test, he/she will be offered an upgrade to HBP and a replacement of the existing device.
The 2 groups in the trial
- His-bundle pacing firstTreatment being tested
AV sequential His-bundle pacing (or VVI pacing if in atrial fibrillation) via temporary right atrial and His-bundle electrodes. Then AV sequential Biventricular pacing via the patient's already implanted CRT device. Measurements of stroke volume, cardiac output, pressure in the right ventricle and pulmonary capillary wedge pressure, during rest and exercise. Simultaneous 12 lead ECG registration.
Treatment: Temporary His bundle pacing
- Biventricular pacing firstExisting treatment, for comparison
AV sequential biventricular pacing (or VVI pacing if in atrial fibrillation) via the patient's already implanted CRT device. Then AV sequential or VVI His-bundle pacing via temporary right atrial and His-bundle electrodes. Measurements of stroke volume, cardiac output, pressure in the right ventricle and pulmonary capillary wedge pressure, during rest and exercise. Simultaneous 12 lead ECG registration.
Treatment: Temporary His bundle pacing
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Acute Hemodynamic Effects of His-bundle Pacing in Bi-Ventricular Pacing Non-responders (The HEPA-His Trial)
- Record updated
- 28 February 2025