Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

Age greater than 18 years
LVEF ≤35%
Either unable to position an LV lead via the standard coronary sinus on CRT implantation
...
Age greater than 18 years
LVEF ≤35%
Either unable to position an LV lead via the standard coronary sinus on CRT implantation
Informed consent
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
NYHA class II-IV
QRS ≥120 milliseconds
Optimal tolerated medical therapy

Exclusion Criteria

Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
Presence of correctable valvular disease (aortic/mitral)
Chronic renal dialysis and End stage liver disease
...
Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
Presence of correctable valvular disease (aortic/mitral)
Chronic renal dialysis and End stage liver disease
Mitral valve prosthesis.
Contra indication to vitamin K antagonist
Unresolved intra-cardiac thrombus
Previous atrial septal defect device closure.
Pregnancy
History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months

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

Age greater than 18 years
LVEF ≤35%
Either unable to position an LV lead via the standard coronary sinus on CRT implantation
...
Age greater than 18 years
LVEF ≤35%
Either unable to position an LV lead via the standard coronary sinus on CRT implantation
Informed consent
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
NYHA class II-IV
QRS ≥120 milliseconds
Optimal tolerated medical therapy

Exclusion Criteria

Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
Presence of correctable valvular disease (aortic/mitral)
Chronic renal dialysis and End stage liver disease
...
Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
Presence of correctable valvular disease (aortic/mitral)
Chronic renal dialysis and End stage liver disease
Mitral valve prosthesis.
Contra indication to vitamin K antagonist
Unresolved intra-cardiac thrombus
Previous atrial septal defect device closure.
Pregnancy
History of stroke, myocardial infarction, unstable angina, Coronary artery bypass grafting and coronary stenting within the last 3 months

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