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

March 20, 2019 updated by: MicroPort CRM

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
348

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et Pneumologie de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: SonR CRT Optimization 'On'
CRT-D device with the SonR optimization algorithm programmed being 'on'.
Device: SonR CRT Optimization 'On'
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.
Other: SonR CRT Optimization 'Off'
CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).
Device: SonR CRT Optimization 'Off'
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CRT-responders rate increase based on LVESV decrease at M6 / baseline
Time Frame: 6 months

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
A-wave truncation assessment at M6
Time Frame: 6 months
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Report LV remodeling from LVEDV decrease at M6 / baseline
Time Frame: 6 months
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
LVEF increase at M6
Time Frame: 6 months
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
AF analysis during FUp
Time Frame: 6 months

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
AF-related events
Time Frame: 6 months
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
LA and RV functions
Time Frame: 6 months
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
Adverse events
Time Frame: 6 months
All AEs observed during FUp in all study patients will be classified by origin, symptoms, severity, treatment and outcome per study arm.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroPort CRM

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: François Philippon, Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICSY01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on SonR CRT Optimization 'On'

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings