Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

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

Exclusion Criteria

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

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

Exclusion Criteria

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