Status:
COMPLETED
Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
Lead Sponsor:
MicroPort CRM
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 rem...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2016
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT01869062
Start Date
June 1 2013
End Date
May 19 2016
Last Update
March 22 2019
Active Locations (1)
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1
Institut universitaire de Cardiologie et Pneumologie de Québec
Québec, Canada, G1V 4G5