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Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure

NCT04701112 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-02-28

No results posted yet for this study

Summary

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.

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.

Conditions

  • Heart Failure, Systolic
  • Left Bundle Branch Block
  • Wide QRS Complex

Interventions

DEVICE

Temporary His bundle pacing

Temporary use of a Medtronic 3830 electrode placed in the region of His bundle, in combination with a Medtronic 5392 dual chamber external pacemaker and a temporary Edwards D200F7 Swan Ganz Pacing -catheter with atrial pacing capability. AV synchronous pacing (DDD 60/minute during rest and 120/minute during exercise, AV delay 150/180ms) will be performed using the atrial port (pacing catheter atrial electrodes) and ventricular port (His bundle electrode), or in the case of atrial fibrillation, only pacing the the His bundle in VVI mode 60/minute during rest and 120/minute during exercise. The Swan-Ganz will then be used for hemodynamic measurements during pacing. A Cardiotek ECG system will be used for simultaneous 12 lead ECG registration.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Oscar Braun, MD PhD · Region Skane, Lund University

  • Rasmus Borgquist, MD PhD · Region Skane, Lund University

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-02-27
Completion
2025-02-27

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701112 on ClinicalTrials.gov