Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography

NCT ID: NCT01869062

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-05-19

Brief Summary

The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT parameters by SonR technology is able to increase the rate of CRT-D responders, based on significant LV reverse remodeling, as compared to Standard of Care settings.

This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard of care (SoC) programming methods in providing appropriate LV filling, as expected from the Ritter method.

Detailed Description

This study will evaluate the effectiveness of CRT-D SonR system as compared to SoC programming methods to:

• Increase the rate of patients responding to CRT
• Provide appropriate hemodynamic cardiac effect, as expected from the Ritter method.

The identification of CRT responders, as defined by echocardiography, generally refers to a significant reduction of the LV End-Systolic Diameter (LVESD) and/or LVESV during Follow-Up (FUp).

Patients will be considered as responders to CRT if their LVESV decreased by > 15% after 6 months of CRT therapy as compared to baseline. The percentage of CRT responders will be compared between the two study arms.

SoC is defined as the standard CRT system programming/optimization method currently used by physicians in study centers and any method may be used in the study if considered as routine practice in the study center.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

SonR CRT Optimization 'On'

CRT-D device with the SonR optimization algorithm programmed being 'on'.

Group Type: OTHER

SonR CRT Optimization 'On'

Intervention Type: DEVICE

Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.

SonR CRT Optimization 'Off'

CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).

Group Type: OTHER

SonR CRT Optimization 'Off'

Intervention Type: DEVICE

Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).

Interventions

SonR CRT Optimization 'On'

Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.

Intervention Type: DEVICE

SonR CRT Optimization 'Off'

Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines ;
• In Sinus Rhythm;
• Have reviewed, signed and dated an informed consent

Exclusion Criteria

• Previous implant with a pacemaker, an Implantable Cardioverter-Defibrillator or a CRT device (except upgrade from single chamber ICD with a fully functional defibrillation lead not under recall or surveillance);
• Persistent atrial arrhythmias (or cardioversion for Atrial Fibrillation) within the past month;
• Ventricular tachyarrhythmia secondary to reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
• Incessant ventricular tachyarrhythmia;
• Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past 4 weeks;
• Correctable valvular disease that is the primary cause of heart failure;
• Mechanical heart valve or indication for valve repair or replacement;
• Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months);
• Post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
• Already included in another clinical study that could confound the results of this study;
• Life expectancy less than 1 year;
• Inability to understand the purpose of the study;
• Unavailability for scheduled follow-up or refusal to cooperate;
• Sensitivity to 1 mg Dexamethasone Sodium Phosphate (DSP);
• Age of less than 18 years;
• Pregnancy;
• Drug addiction or abuse;
• Under guardianship

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MicroPort CRM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Philippon

Role: PRINCIPAL_INVESTIGATOR

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Locations

Institut universitaire de Cardiologie et Pneumologie de Québec

Québec, , Canada

Countries

Canada

Other Identifiers

ICSY01

Identifier Type: -

Identifier Source: org_study_id