Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device

Clinical Evaluation Of SonR Atrial Lead In Paradym RF Device SORIN GROUP'S New ICD Plateform

Sorin Group has developed a new atrial lead which is under evaluation during this study. The SonR atrial lead presents a new sensor in the tip of the lead and allows a new feature; interventricular (VV) and atrioventricular (AV) delay (VVD and AVD) optimization.

The new RV autothreshold algorithm has been implemented in the CRT-ICD and will help the physician in his diagnosis avoiding potential lost of capture.

The ICD device has also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.

Finally, the study will report the electrical and handling performances of the new left ventricular lead.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: CRT-SonR 9770

Detailed Description

In this study, the sponsor aims at:

• Demonstrating the safety of the atrial SonR lead;
• Demonstrating the performances of the right ventricular autothreshold algorithm ;
• Reporting the adverse events documented in the study;
• Reporting electrical performances of Sorin Group PARADYM ICD, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
• Reporting the Sorin atrial SonR and Situs 2 MV left ventricular leads performances;
• Reporting the SonR atrial lead mechanical handling.
• Reporting all information from SonR sensor to validate the SonR data exploitation and the AVD/VVD optimization.
• Reporting the Situs 2 MV LV lead mechanical handling.
• Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.

Thus, this study intends to show that PARADYM RF ICD operate safely and appropriately in intended-use as part of an ICD system.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Leclercq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient eligible for implantation of a CRT 9770 device accordingly to the relevant currently-approved ACC/AHA/ESC guidelines or any relevant currently approved local guidelines for the implantation or replacement of triple-chamber ICD
• Implanted with atrial SonR lead
• Signed and dated informed consent

Exclusion Criteria:

• VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
• VT/VF occurred during the acute phase of infarction (< 3 weeks) or during an unstable ischemic phase;
• VF was caused by electrocution;
• Incessant VT/VF;
• Patient is unable to attend the scheduled follow-ups at the implanting centre;
• Patient is already enrolled in another ongoing clinical study;
• Patient is unable to understand the aim of the study and its procedure;
• Patient refuses to cooperate;
• Patient is unable or refuses to provide informed consent;
• Patient is minor (less than 18-year old);
• Patient is pregnant;
• Patient has life expectancy of less than 1 year;
• Patient is forfeiture of freedom or under guardianship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CRT-SonR 9770; Active implantable defibrillator with ability to cardiac resynchronization therapy	Device: CRT-SonR 9770; Active implantable defibrillator with capacity of cardiac resynchronization therapy; Other Names: 9770

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the SonR lead safety	Complication free rate of the SonR lead superior to 90 %	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Any adverse will be documented thoughout the study and will be reported.	12 months
ICD electrical performances	Report all ICD electrical performances of the Paradym RF ICD	12 months
Evaluation of the SonR atrial lead performance	Report electrical performances and lead handling at implant	3 months
Evaluation of the AV/VV delays optimization	Describe the performances of the manual and automatic AV/VV optimization algorithms. An optional daily life test could be performed to evaluate the automatic optimization at exercise.	3 months
Evaluation of the left ventricular lead performances	Report the electrical performances and lead mechanical handling at implant.	12 months
Evaluation of the Remote Monitoring Solution	Ensure the Home Monitor setup procedure and daily life use are user friendly for the patient and the back office is convenient for the physician.	12 months
Evaluation of the right ventricular autothreshold performances	Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test with an authorized error of 0,25V.	1 month

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: Christophe CL Leclercq, Ryhtmologist, Chu Rennes

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: July 20, 2010
• First Submitted That Met QC Criteria: July 23, 2010
• First Posted (ESTIMATE): July 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: ICD CRT 9770 - PARADYM RF ICD - SonR atrial lead
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SonR Study - ITSY05