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

Sponsor
MicroPort CRM (Industry)
Overall Status
Completed
CT.gov ID
NCT01869062
Collaborator
(none)
348
Enrollment
1
Location
2
Arms
35.6
Actual Duration (Months)
9.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SonR CRT Optimization 'On'
  • Device: SonR CRT Optimization 'Off'
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
348 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
CRT-D deviceCRT-D device
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
Actual Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
May 19, 2016
Actual Study Completion Date :
May 19, 2016

Arms and Interventions

Arm Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

  1. CRT-responders rate increase based on LVESV decrease at M6 / baseline [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.

Secondary Outcome Measures

  1. A-wave truncation assessment at M6 [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.

Other Outcome Measures

  1. Report LV remodeling from LVEDV decrease at M6 / baseline [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.

  2. LVEF increase at M6 [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.

  3. AF analysis during FUp [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.

  4. AF-related events [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.

  5. LA and RV functions [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. Adverse events [6 months]

    All AEs observed during FUp in all study patients will be classified by origin, symptoms, severity, treatment and outcome per study arm.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut universitaire de Cardiologie et Pneumologie de Québec Québec Canada G1V 4G5

Sponsors and Collaborators

  • MicroPort CRM

Investigators

  • Principal Investigator: François Philippon, Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MicroPort CRM
ClinicalTrials.gov Identifier:
NCT01869062
Other Study ID Numbers:
  • ICSY01
First Posted:
Jun 5, 2013
Last Update Posted:
Mar 22, 2019
Last Verified:
Mar 1, 2019
Keywords provided by MicroPort CRM
CRT
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Mar 22, 2019