LV Endocardial Cardiac Resynchronisation Therapy
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- OR Recipient of a CRT-P or CRT-D system for greater than 6 months for standard indications AND limited improvement or worsened clinical status despite device optimisation
- Optimal tolerated medical therapy
- LVEF ≤35%
- ...
- OR Recipient of a CRT-P or CRT-D system for greater than 6 months for standard indications AND limited improvement or worsened clinical status despite device optimisation
- Optimal tolerated medical therapy
- LVEF ≤35%
- Age greater than 18 years
- Either unable to position an LV lead via the standard coronary sinus on CRT implantation
- Informed consent
- NYHA class II-IV
- QRS ≥120 milliseconds
Exclusion Criteria
- Presence of correctable valvular disease (aortic/mitral)
- History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months
- Unresolved intra-cardiac thrombus
- ...
- Presence of correctable valvular disease (aortic/mitral)
- History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months
- Unresolved intra-cardiac thrombus
- Mitral valve prosthesis.
- Contra indication to vitamin K antagonist
- Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
- Chronic renal dialysis and End stage liver disease
- Previous atrial septal defect device closure.
- Pregnancy
Summary
- Conditions
- Heart Failure
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- OR Recipient of a CRT-P or CRT-D system for greater than 6 months for standard indications AND limited improvement or worsened clinical status despite device optimisation
- Optimal tolerated medical therapy
- LVEF ≤35%
- ...
- OR Recipient of a CRT-P or CRT-D system for greater than 6 months for standard indications AND limited improvement or worsened clinical status despite device optimisation
- Optimal tolerated medical therapy
- LVEF ≤35%
- Age greater than 18 years
- Either unable to position an LV lead via the standard coronary sinus on CRT implantation
- Informed consent
- NYHA class II-IV
- QRS ≥120 milliseconds
Exclusion Criteria
- Presence of correctable valvular disease (aortic/mitral)
- History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months
- Unresolved intra-cardiac thrombus
- ...
- Presence of correctable valvular disease (aortic/mitral)
- History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months
- Unresolved intra-cardiac thrombus
- Mitral valve prosthesis.
- Contra indication to vitamin K antagonist
- Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
- Chronic renal dialysis and End stage liver disease
- Previous atrial septal defect device closure.
- Pregnancy
Tracking Information
- NCT #
- NCT02174289
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Tom Wong, MD FESC Royal Brompton and Harefield NHS Foundation Trust
- Tom Wong, MD FESC Royal Brompton and Harefield NHS Foundation Trust
Get Well Soon