Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

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

Exclusion Criteria

Pregnancy
Mitral valve prosthesis.
Contra indication to vitamin K antagonist
...
Pregnancy
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.
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

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

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

Exclusion Criteria

Pregnancy
Mitral valve prosthesis.
Contra indication to vitamin K antagonist
...
Pregnancy
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.
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

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