Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

Optimal tolerated medical therapy
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
...
Optimal tolerated medical therapy
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
Age greater than 18 years
Informed consent
QRS ≥120 milliseconds
LVEF ≤35%
NYHA class II-IV

Exclusion Criterias

Presence of correctable valvular disease (aortic/mitral)
Chronic renal dialysis and End stage liver disease
Mitral valve prosthesis.
...
Presence of correctable valvular disease (aortic/mitral)
Chronic renal dialysis and End stage liver disease
Mitral valve prosthesis.
Unresolved intra-cardiac thrombus
Previous atrial septal defect device closure.
Contra indication to vitamin K antagonist
Pregnancy
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

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 Criterias

Optimal tolerated medical therapy
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
...
Optimal tolerated medical therapy
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
Age greater than 18 years
Informed consent
QRS ≥120 milliseconds
LVEF ≤35%
NYHA class II-IV

Exclusion Criterias

Presence of correctable valvular disease (aortic/mitral)
Chronic renal dialysis and End stage liver disease
Mitral valve prosthesis.
...
Presence of correctable valvular disease (aortic/mitral)
Chronic renal dialysis and End stage liver disease
Mitral valve prosthesis.
Unresolved intra-cardiac thrombus
Previous atrial septal defect device closure.
Contra indication to vitamin K antagonist
Pregnancy
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

Locations

London
London

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