Comparison of Cardiac Resynchronisation Therapy (CRT) Response Using High Frequency (HF) - ECG or Q-LV Guided Optimisation for Left Ventricular, Pacing Site.
- Conditions
- Heart Failure
- Registration Number
- NCT05829876
- Lead Sponsor
- University Hospital Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - • Eligible for implantation of a CRT-D device according to published relevant ESC<br> and CCS guidelines;<br><br> - In sinus rhythm;<br><br> - NYHA class II, III or IV<br><br> - Have reviewed, signed and dated an informed consent.<br><br> - Age 18<br><br>Exclusion Criteria:<br><br> - Previous implant with a pacemaker, an ICD or a CRT device. (except upgrade from<br> single chamber ICD with a fully functional defibrillation lead) not under recall or<br> surveillance);<br><br> - Persistent atrial arrhythmias (or cardioversion for atrial fibrillation) within the<br> past month;<br><br> - Ventricular tachyarrhythmia of transient or reversible causes such as acute<br> myocardial infarction (MI), digitalis intoxication, drowning, electrocution,<br> electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;<br><br> - Incessant ventricular tachyarrhythmia;<br><br> - Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or<br> Percutaneous Coronary Intervention (PCI) within the past 4 weeks;<br><br> - Correctable valvular disease that is the primary cause of heart failure;<br><br> - Indication for valve repair or replacement;<br><br> - Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within<br> the previous 3 months);<br><br> - On transplant waiting list;<br><br> - Previous heart transplant;<br><br> - Already included in another clinical study that could confound the results of this<br> study;<br><br> - Life expectancy less than 1 year;<br><br> - Inability to understand the purpose of the study;<br><br> - Unavailability for scheduled follow-up or refusal to cooperate;<br><br> - Age of less than 18 years;<br><br> - Pregnancy;<br><br> - Drug addiction or abuse;<br><br> - Under guardianship.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Left Ventricular Reverse Remodelling
- Secondary Outcome Measures
Name Time Method Change in NYHA Class;Change in quality of life score;Change in left ventricular ejection fraction;Reduction in QRS duration