Sensor Optimization of Cardiac Resynchronization Therapy Response

Heart Failure Clinical Trial

— SOCR  

Official title:

Sensor Optimization of CRT Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01832493
• Other study ID #: SOCR
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2013
• Last updated: January 29, 2016
• Start date: July 2013
• Est. completion date: April 2016

Study information

• Verified date: January 2016
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: SOCR Clinical Trial Leader
• Email: medtronicCRMtrials[@]medtronic.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Medtronic Cardiac Resynchronization Therapy Device

Locations

Country	Name	City	State
Canada	Ottawa Heart Institute	Ottawa	Ontario
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Québec	Quebec
Canada	Victoria Cardiac Arrhythmia Trials	Victoria	British Columbia
United Kingdom	Kings College Hospital	London
United States	The Ohio State University	Columbus	Ohio
United States	Iowa Heart Center	Des Moines	Iowa
United States	Mercy Hospital Fairfield	Fairfield	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects where the optimal setting as determined by intracardiac impedance agrees within one AV interval setting of the optimal setting determined by LV dP/dt max.		intraoperative testing only	No
Primary	Percentage of subjects where the optimal setting as determined by heart sounds agrees within one AV interval setting of the optimal setting determined by LV dP/dt max.		intraoperative testing only	No