Clinical trial NCT01869062: Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
Official title: Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: CRT
Lead sponsor: MicroPort CRM
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CRT-D device
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: CRT-responders rate increase based on LVESV decrease at M6 / baseline
timeFrame: 6 months
Secondary outcomes:
measure: A-wave truncation assessment at M6
timeFrame: 6 months
Other outcomes:
measure: Report LV remodeling from LVEDV decrease at M6 / baseline
timeFrame: 6 months
measure: LVEF increase at M6
timeFrame: 6 months
measure: AF analysis during FUp
timeFrame: 6 months
measure: AF-related events
timeFrame: 6 months
measure: LA and RV functions
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
Locations:
city: Québec
country: Canada
facility: Institut universitaire de Cardiologie et Pneumologie de Québec
Study officials:
affiliation: Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
name: François Philippon
role: PRINCIPAL_INVESTIGATOR
References: