Bradyarrhythmia Clinical Trial
Official title:
Mechanical and Electrical Dyssynchrony During His-Bundle Pacing (Selective and Non-selective) Versus His-Bundle Area Right Ventricular Pacing
The aim of this study is to evaluate mechanical and electrical cardiac dyssynchrony in patients with pacemakers and the right ventricular electrode implanted in His Bundle area.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - all adult patients after implantation of pacemaker system with pacing lead successfully captured His Bundle (selectively or/and nonselectively) Exclusion Criteria: - not willing or incapable to give written informed consent; - previous implanted cardiac electronic device (pacemaker, implantable cardioverter-defibrillator, cardiac resynchronization therapy device) |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Electrocardiology Medical University of Lodz | Lodz |
Lead Sponsor | Collaborator |
---|---|
Medical University of Lodz |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Interventricular mechanical delay | InterVentricular Mechanical Dyssynchrony Parameter 1 | Mid-term: 3-6 months after pacemaker implantation | |
Primary | Interventricular mechanical delay | InterVentricular Mechanical Dyssynchrony Parameter 1 | Long term: 12-15 months after pacemaker implantation | |
Primary | Free-wall-LV-to-RV-delay | InterVentricular Mechanical Dyssynchrony Parameter 2 | Mid-term: 3-6 months after pacemaker implantation | |
Primary | Free-wall-LV-to-RV-delay | InterVentricular Mechanical Dyssynchrony Parameter 2 | Long term: 12-15 months after pacemaker implantation | |
Primary | Septal-to-posterior wall motion delay | IntraVentricular Mechanical Dyssynchrony Parameter 1 | Mid-term: 3-6 months after pacemaker implantation | |
Primary | Septal-to-posterior wall motion delay | IntraVentricular Mechanical Dyssynchrony Parameter 1 | Long term: 12-15 months after pacemaker implantation | |
Primary | Opposing wall motion delay | IntraVentricular Mechanical Dyssynchrony Parameter 2 | Long term: 12-15 months after pacemaker implantation | |
Primary | Opposing wall motion delay | IntraVentricular Mechanical Dyssynchrony Parameter 2 | Mid-term: 3-6 months after pacemaker implantation | |
Primary | systolic dyssynchrony index | Ventricular Mechanical Dyssynchrony Parameter 1 | Long term: 12-15 months after pacemaker implantation | |
Primary | systolic dyssynchrony index | Ventricular Mechanical Dyssynchrony Parameter 1 | Mid-term: 3-6 months after pacemaker implantation | |
Primary | QRS duration | Electrical dyssynchrony Parameter | Mid-term: 3-6 months after pacemaker implantation | |
Primary | QRS duration | Electrical dyssynchrony Parameter | Long term: 12-15 months after pacemaker implantation | |
Secondary | Radial strain | Additional Ventricular Mechanical Dyssynchrony Parameter 1 | Mid-term: 3-6 months after pacemaker implantation | |
Secondary | Radial strain | Additional Ventricular Mechanical Dyssynchrony Parameter 1 | Long term: 12-15 months after pacemaker implantation | |
Secondary | Left Ventricular Ejection Fraction | Global left ventricle function parameter | Mid-term: 3-6 months after pacemaker implantation | |
Secondary | Left Ventricular Ejection Fraction | Global left ventricle function parameter | Long term: 12-15 months after pacemaker implantation | |
Secondary | Global longitudinal strain | Global left ventricle function parameter 2 | Mid-term: 3-6 months after pacemaker implantation | |
Secondary | Global longitudinal strain | Global left ventricle function parameter 2 | Long term: 12-15 months after pacemaker implantation | |
Secondary | Left ventricular output track velocity-time integral | Global left ventricle function parameter 3 | Mid-term: 3-6 months after pacemaker implantation | |
Secondary | Left ventricular output track velocity-time integral | Global left ventricle function parameter 3 | Long term: 12-15 months after pacemaker implantation | |
Secondary | Diastolic Filling Time | Atrioventricular Dyssynchrony Parameter | Mid-term: 3-6 months after pacemaker implantation | |
Secondary | Diastolic Filling Time | Atrioventricular Dyssynchrony Parameter | Long term: 12-15 months after pacemaker implantation |
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