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Bundle-Branch Block clinical trials

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NCT ID: NCT05265520 Recruiting - Heart Failure Clinical Trials

His-Bundle Corrective Pacing in Heart Failure

HIS-CRT
Start date: December 2, 2022
Phase: N/A
Study type: Interventional

The investigators aim to prospectively evaluate the efficacy and mechanism of benefit of His-bundle pacing enhanced cardiac resynchronization therapy (His-CRT) vs. cardiac resynchronization therapy (BIV-CRT) in patients with heart failure and right bundle branch block (RBBB).

NCT ID: NCT05251363 Active, not recruiting - Bradycardia Clinical Trials

BIOTRONIK Conduction System Pacing With the Solia Lead

BIO-CONDUCT
Start date: December 12, 2022
Phase: N/A
Study type: Interventional

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area. Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.

NCT ID: NCT05155865 Active, not recruiting - Heart Failure Clinical Trials

Conduction System Pacing Versus Biventricular Pacing for Cardiac resYNChronization

CSP-SYNC
Start date: January 10, 2022
Phase: N/A
Study type: Interventional

Cardiac resynchronization therapy (CRT) with biventricular pacing (BiV) is the cornerstone treatment for heart failure patients with ventricular dyssynchrony. Recently, a new concept, conduction system pacing (CSP) with permanent pacing, including His bundle pacing and left bundle branch pacing, has been proposed as a potential alternative to conventional BiV-CRT. The prospective, randomized trial will compare echocardiographic, electrocardiographic, and clinical effects of CSP versus conventional BiV pacing in heart failure patients with reduced ejection fraction (LVEF ≤ 35%), sinus rhythm, and left bundle branch block. Patients will be randomized to either CSP or biventricular pacing study group and followed up for at least 6 months. The study will explore whether CSP is non-inferior to BiV pacing in echocardiographic, electrocardiographic, and clinical outcomes.

NCT ID: NCT04897659 Completed - Clinical trials for Aortic Valve Disease

Left Bundle Branch Block (LBBB) After IntuityTM

Start date: January 1, 2021
Phase:
Study type: Observational

This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis. It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.

NCT ID: NCT04749836 Recruiting - AV Block Clinical Trials

Outcomes and Safety of Various Conduction System Pacing Methods

Start date: February 4, 2021
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to evaluate safety and clinical outcomes after different pacing approaches of conduction system pacing in a prospective registry.

NCT ID: NCT04701112 Suspended - Clinical trials for Heart Failure, Systolic

Acute Hemodynamic Effects of Pacing the His Bundle in Heart Failure

HEPA-His
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04658953 Completed - Clinical trials for Chronic Low-back Pain

Comparison of the Effectiveness of Ultrasound-guided Versus Radioguided Medial Lumbar Bundle Branch Block

Start date: January 6, 2021
Phase: N/A
Study type: Interventional

In adults with chronic low back pain, the investigators will compare the effectiveness of the medial bundle branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed either by radiographic guidance or by ultrasound approach according to a transverse approach. The objective of this study will be to evaluate the benefit of these both procedures on pain, on the practice of daily activities and the incidence of adverse events in order to show whether the two modalities are equivalent.

NCT ID: NCT04537455 Completed - Clinical trials for Left Bundle-Branch Block

Non-invasive Mapping Using Ultra-high Frequency Electrocardiography

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Cardiac electrical mapping is an important tool that allows doctors to study the electrical activity of the heart in detail. Electrical mapping systems used in clinical practice are time consuming, invasive and very costly. Ultra-high frequency electrocardiography is a novel non-invasive cardiac mapping system. Ultra-high frequency electrocardiography (UHF-ECG) can be performed in 10-15 minutes without any risk or discomfort to patients. The aim of this study is to refine this mapping system, verify it against invasive mapping and develop software to bring this novel system into routine clinical use including predicting which patients will respond to cardiac resynchronisation therapy.

NCT ID: NCT04416958 Recruiting - ICD Clinical Trials

Pacing to Maintain Physiologic Ventricular Activation

Pace-Conduct
Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

Right ventricular pacing causes ventricular dyssynchrony and may be associated with impaired outcome. In the last decade, several approaches for more physiological pacing became available and were implemented in the latest guidelines. However, compared to conventional device implantation, cardiac resynchronization, His bundle pacing and left bundle area pacing remain demanding procedures in the individual case. Goal of the single center observational "Pace conduct" study is to evaluate implantation success, safety and outcome of pacing methods that maintain physiologic ventricular activation.

NCT ID: NCT04409119 Recruiting - Heart Failure Clinical Trials

Direct HIS/LBB Pacing as an Alternative to Biventricular Pacing in Patients With HFrEF and a Typical LBBB.

HIS-alt_2
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The study will investigate the feasibility of using direct HIS pacing or left bundle branch pacing (LBB pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ECG with a typical left bundle branch block pattern.