None listed
Conditions
Brief summary
A single centre study collecting and analyzing intra-thoracic and intra-cardiac electrical impedance measurements, intra-cardiac conduction time delays, and the left ventricular evoked response signal parameters from the St Jude Medical Cardiac Resynchronization Therapy (SJM CRT) device in a heart failure population with an implanted left atrial pressure sensor.
Interventions
Patients requiring the insertion of a Bi-ventricular pacemaker/defibrillator, for treatment of ventricular dyssynchrony and heart failure, will be offered the oppurtunity to participate in this trial. The sponsor will provide the PROMOTE device Model 3213, or later automatic internal cardiac defibrillator devices with similar functions. A HeartPOD (Left Atrial Pressure monitoring device) will be implanted at the same time. Research of the new features of the PROMOTE device to capture intra-thora
Patients requiring the insertion of a Bi-ventricular pacemaker/defibrillator, for treatment of ventricular dyssynchrony and heart failure, will be offered the oppurtunity to participate in this trial. The sponsor will provide the PROMOTE device Model 3213, or later automatic internal cardiac defibrillator devices with similar functions. A HeartPOD (Left Atrial Pressure monitoring device) will be implanted at the same time. Research of the new features of the PROMOTE device to capture intra-thoracic and intra-cardiac electrical impedance measurements and left atrial pressures will be done. The completion of the trial will be when the 12th participant has had one year of follow-up.
Sponsors
St Jude Medical
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Age>18 and <=85;an approved indication for cardiac resynchronization therapy via pacemaker(CRT-P) or cardiac resynchronization therapy via defibrillator(CRT-D);may be a Homeostasis 1 trial participant;able and willing to participate as per the trial protocol.
Exclusion criteria
Intractable Heart Failure or listed for cardiac transplantation; Acute Myocardial Infarction or Acute Coronary Syndrome; Recent surgery or (Percutaneous Coronary Intervention(PCI);Cerebrovascular Accident (CVA);Transient Ischaemic Attack(TIA);Pulmonary Embolus (PE);Deep Vein Thrombosis(DVT).
Outcome results
None listed