Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure

NCT04701112 | Terminated

• 1 other identifier: Hepa-His trial
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

His Bundle pacing; Cardiac Resynchronization Therapy; Pacemaker

Outcome Measures

Primary Outcomes (1)

• Change in stroke volume (ml) at rest, between Biventricular pacing compared to His bundle pacing

  Stroke volume will be measured using the thermodilution method, and paired T-test will be used to evaluate the change in stroke volume between the different pacing modes.

  During procedure

Secondary Outcomes (6)

• Change in stroke volume (ml) at sub-maximal exercise, between Biventricular pacing compared to His bundle pacing

  During procedure

• Change in Cardiac output (l/min) at rest, between Biventricular pacing compared to His bundle pacing

  During procedure

• Change in cardiac output (l/min) at submaximal exercise, between Biventricular pacing compared to His bundle pacing

  During procedure

• Change in stroke work index (mmHg x ml/m2) at rest, between Biventricular pacing compared to His bundle pacing

  During procedure

• Change in stroke work index (mmHg x ml/m2) at sub-maximal exercise, between Biventricular pacing compared to His bundle pacing

  During procedure

Other Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events, defined as pneumothorax or pericardial effusion.

  From start of procedure to 2 hours post-procedure

• Incidence of Treatment-Emergent Adverse Events, defined as local access site bleeding.

  From start of procedure to 2 hours post-procedure

Study Arms (2)

His-bundle pacing first

EXPERIMENTAL

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.

Device: Temporary His bundle pacing

Biventricular pacing first

ACTIVE COMPARATOR

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.

Device: Temporary His bundle pacing

Interventions

Temporary His bundle pacing DEVICE

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.

Biventricular pacing first; His-bundle pacing first

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known access site problems in vena jugularis interna dx or sin
• Not able to perform supine cycling
• Presence of severe tricuspid regurgitation

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospital

Lund, Sweden

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Oscar Braun, MD PhD

  Region Skane, Lund University

  PRINCIPAL INVESTIGATOR

• Rasmus Borgquist, MD PhD

  Region Skane, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient is not aware of the pacing modality used for each measurement. The outcomes assessment will be performed blinded to pacing modality.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 8, 2021
• Study Start: September 1, 2021
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: February 28, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)