Sensor Optimization of Cardiac Resynchronization Therapy Response (SOCR)

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Cardiac Resynchronization Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01832493

SOCR

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Cardiac Resynchronization Therapy

Experimental group

Description:

Patients implanted with a cardiac resynchronization therapy device

Treatment:

Device: Cardiac Resynchronization Therapy