Ultra-high-frequency ECG for Prediction of Left Ventricular Remodeling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

368 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2025-12-01

Brief Summary

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The main goal of the project is to prove that ultra-high-frequency ECG (UHF-ECG) can be used as a diagnostic tool that allows the prediction of patients susceptible to the negative effect of right ventricular myocardial pacing. The prediction will be based on the assessment of electrical dyssynchrony and local depolarization durations of left ventricular depolarization emerging during right ventricular pacing. If proved to be valid in left ventricular negative remodeling prediction, UHF-ECG-derived parameters of ventricular dyssynchrony could be used as markers allowing a lead placement optimization during an implant procedure. This information can help the operator to identify patients with the urgent need for physiological pacing (HB or LBBp) and patients in which a right ventricular myocardial pacing is sufficient and will not lead to the development of the negative left ventricular remodeling.

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Detailed Description

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Conditions

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RV Pacing Negative Remodeling Dyssynchrony UHF-ECG Physiological Pacing

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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myocardial pacing group

patients with the pacing lead placed into the right ventricle to obtain myocardial capture

pacemaker implantation

Intervention Type DEVICE

pacemaker implantation

physiological pacing group

patients with the pacing lead placed into the His bundle or left bundle branch area

pacemaker implantation

Intervention Type DEVICE

pacemaker implantation

Interventions

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pacemaker implantation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. expectation of permanent right ventricular pacing with atrio-ventricular delay set to 150/180 ms (130/160 resp.) for sensed/paced atrial events during a follow-up,
2. a good quality of images during echocardiography,
3. willingness to attend clinical check-ups in the implanting center for at least two years.
4. life expectancy of at least 2 years

Exclusion Criteria

1. planned cardiac surgery or transcatheter aortic valve implantation
2. hypertrophic cardiomyopathy
3. an indication for implantable cardioverter-defibrillator, biventricular implantable cardioverter-defibrillator, or biventricular pacemaker
4. active myocarditis
5. cardiac surgery or coronary revascularization in the last ten days
6. persistent/permanent atrial fibrillation during randomization
7. severe aortic stenosis
8. mitral valvular disease with an indication to intervention.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No