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

NCT01869062 | Completed

• 1 other identifier: ICSY01
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

CRT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A-wave truncation assessment at M6

  6 months

Other Outcomes (6)

• Report LV remodeling from LVEDV decrease at M6 / baseline

  6 months

• LVEF increase at M6

  6 months

• AF analysis during FUp

  6 months

Study Arms (2)

SonR CRT Optimization 'On'

OTHER

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

Device: SonR CRT Optimization 'On'

SonR CRT Optimization 'Off'

OTHER

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

Device: SonR CRT Optimization 'Off'

Interventions

SonR CRT Optimization 'On' DEVICE

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

SonR CRT Optimization 'On'

SonR CRT Optimization 'Off' DEVICE

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

SonR CRT Optimization 'Off'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• MicroPort CRM: lead

Study Sites (1)

Institut universitaire de Cardiologie et Pneumologie de Québec

Québec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• François Philippon

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: CRT-D device

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2013
• Primary Completion: May 19, 2016
• Study Completion: May 19, 2016
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

CA (1)