Clinical trial NCT01832493: Sensor Optimization of Cardiac Resynchronization Therapy Response
Official title: Sensor Optimization of CRT Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Sensor Optimization of Cardiac Resynchronization Therapy (CRT) Response (SOCR) Study is a multicenter, prospective, non-randomized acute feasibility study that is being conducted to determine if subcutaneous heart sounds and/or intracardiac impedance can acutely identify the optimal atrioventricular (AV) pacing intervals and optimal left ventricular (LV) electrodes in patients indicated for cardiac resynchronization therapy.


Eligibility criteria: Inclusion Criteria:

* Subject must be undergoing implant of a new or replacement/upgrade Medtronic CRT-P or CRT-D device for approved indications.
* Subject is implanted or will be implanted with an right ventricular (RV) lead that supports bipolar pacing and sensing (e.g. a bipolar pace/sense lead or a true bipolar defibrillation leads)
* Subject (or subject's legally authorized representative) must be willing to give informed consent
* Subjects must be at least 18 years of age

Exclusion Criteria:

* Subject has congenital heart disease
* Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure
* Subject has unstable coronary artery disease
* Subject cannot undergo transvenous catheterization
* Subject has a mechanical tricuspid or aortic valve prosthesis or history of significant structural tricuspid or aortic valvular disease
* Subject requires dual chamber cardiac pacing or single chamber (ventricular) pacing at rest for rate control
* Subject has a recent echocardiogram (within prior 6 months) which revealed the presence of an LV thrombus
* Subject is pregnant
* Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager

Primary outcomes:
measure: AV Interval Determination Using Impedance
timeFrame: During implant
measure: AV Interval Determination Using Heart Sounds
timeFrame: During implant
measure: Optimal Electrode Configuration Determination Using Impedance
timeFrame: During implant
measure: Optimal Electrode Configuration Determination Using Heart Sounds
timeFrame: During implant
Secondary outcomes:
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Fairfield
country: United States
facility: Mercy Hospital Fairfield
state: Ohio
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials
state: British Columbia
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec
state: Quebec
city: Hong Kong
country: Hong Kong
facility: Grantham Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Medtronic CRHF
name: SOCR Clinical Trial Leader
role: STUDY_DIRECTOR
References: