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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
SonR CRT Optimization 'On'
SonR CRT Optimization 'Off'
Sponsored by
MicroPort CRM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring CRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institut universitaire de Cardiologie et Pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

SonR CRT Optimization 'On'

SonR CRT Optimization 'Off'

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 27, 2013
Last Updated
March 20, 2019
Sponsor
MicroPort CRM
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1. Study Identification

Unique Protocol Identification Number
NCT01869062
Brief Title
Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
Acronym
SonR-ECHO
Official Title
Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
May 19, 2016 (Actual)
Study Completion Date
May 19, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort CRM

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
CRT

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
CRT-D device
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SonR CRT Optimization 'On'
Arm Type
Other
Arm Description
CRT-D device with the SonR optimization algorithm programmed being 'on'.
Arm Title
SonR CRT Optimization 'Off'
Arm Type
Other
Arm Description
CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).
Intervention Type
Device
Intervention Name(s)
SonR CRT Optimization 'On'
Intervention Description
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.
Intervention Type
Device
Intervention Name(s)
SonR CRT Optimization 'Off'
Intervention Description
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).
Primary Outcome Measure Information:
Title
CRT-responders rate increase based on LVESV decrease at M6 / baseline
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
A-wave truncation assessment at M6
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Report LV remodeling from LVEDV decrease at M6 / baseline
Description
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.
Time Frame
6 months
Title
LVEF increase at M6
Description
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.
Time Frame
6 months
Title
AF analysis during FUp
Description
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.
Time Frame
6 months
Title
AF-related events
Description
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.
Time Frame
6 months
Title
LA and RV functions
Description
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.
Time Frame
6 months
Title
Adverse events
Description
All AEs observed during FUp in all study patients will be classified by origin, symptoms, severity, treatment and outcome per study arm.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Philippon
Organizational Affiliation
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de Cardiologie et Pneumologie de Québec
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

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

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