NCT01832493

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable heart-failure

Geographic Reach
4 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 16, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 29, 2016

Completed
Last Updated

August 29, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

March 20, 2013

Results QC Date

July 18, 2016

Last Update Submit

July 18, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

  • AV Interval Determination Using Impedance

    Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.

    During implant

  • AV Interval Determination Using Heart Sounds

    Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max

    During implant

  • Optimal Electrode Configuration Determination Using Impedance

    Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max

    During implant

  • Optimal Electrode Configuration Determination Using Heart Sounds

    Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max

    During implant

Study Arms (1)

Cardiac Resynchronization Therapy

EXPERIMENTAL

Patients implanted with a cardiac resynchronization therapy device

Device: Cardiac Resynchronization Therapy

Interventions

Cardiac Resynchronization TherapyDEVICE

All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.

Cardiac Resynchronization Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Iowa Heart Center

Des Moines, Iowa, 50314-3017, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Mercy Hospital Fairfield

Fairfield, Ohio, 45014, United States

Location

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, V8R 4R2, Canada

Location

Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, GIV 4G5, Canada

Location

Grantham Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

  • Luo H, Westphal P, Shahmohammadi M, Heckman LIB, Kuiper M, Cornelussen RN, Delhaas T, Prinzen FW. Heart sound-derived systolic time intervals for atrioventricular delay optimization in cardiac resynchronization therapy. Heart Rhythm. 2023 Apr;20(4):572-579. doi: 10.1016/j.hrthm.2022.12.031. Epub 2022 Dec 24.

    PMID: 36574867DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Results Point of Contact

Title
Medtronic SOCR Clinical Trial Leader
Organization
Medtronic CRHF
medtronicCRMtrials@medtronic.com
1-800-328-2518

Study Officials

  • SOCR Clinical Trial Leader

    Medtronic CRHF

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2013

First Posted

April 16, 2013

Study Start

July 1, 2013

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

August 29, 2016

Results First Posted

August 29, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)CA(3)US(3)GB(1)