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

Heart Failure Clinical Trial

— SonR-ECHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869062
• Other study ID #: ICSY01
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: May 19, 2016

Study information

• Verified date: March 2019
• Source: MicroPort CRM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: May 19, 2016
• Est. primary completion date: May 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• SonR CRT Optimization 'On'
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.
• SonR CRT Optimization 'Off'
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).

Locations

Country	Name	City	State
Canada	Institut universitaire de Cardiologie et Pneumologie de Québec	Québec

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort CRM

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Report LV remodeling from LVEDV decrease at M6 / baseline	LVEDV is a standard marker of CRT effectiveness. Echocardiographic data collected at M6 FUp will document the evolution of LVEDV as compared to baseline in order to assess CRT effectiveness.	6 months
Other	LVEF increase at M6	LVEF, as a surrogate of LVESV and LVEDV, is a standard marker of CRT effectiveness. Echocardiographic data collected at M6 FUp will document the evolution of LVEF as compared to baseline in order to assess CRT effectiveness.	6 months
Other	AF analysis during FUp	Sorin commercialized CRT-D device offering both SonR optimization algorithm and atrio biventricular provides a performing Mode Switch (MS) function able to store and document sustained AF episodes during FUp.; The MS data stored inSorin commercialized CRT-D device offering both SonR optimization algorithm and atrio biventricular memories will be collected at each FUp in order to report total AF burden, permanent AF and AF event free-rate in both arms up to M6 FUp.	6 months
Other	AF-related events	Number of AF-events per patients, the event type, time to the first occurrence, the survival (event-free) curves will be reported per study group.	6 months
Other	LA and RV functions	Echocardiographic data from each exam will be analyzed in order to report the evolution of the diastolic and systolic functions of the LA and of the RV per study group.	6 months
Other	Adverse events	All AEs observed during FUp in all study patients will be classified by origin, symptoms, severity, treatment and outcome per study arm.	6 months
Primary	CRT-responders rate increase based on LVESV decrease at M6 / baseline	For the purpose of this study, CRT-responders are defined as patients experiencing a decrease in LVESV of 15% or more at M6 Fup as most clinical trials used.; The main objective of the SONR-ECHO trial is to show a minimum increase of CRT-responders rate of 15% (up to 72% or more) in the SonR study group as compared to SoC arm.	6 months
Secondary	A-wave truncation assessment at M6	The Ritter's method attempts to optimize AV and VV timings in dual-chamber PM patients. According to this method, AV delay is optimal when LVFT is maximal and mitral valve closure only occurs after atrial systole (A-wave) is complete.	6 months