Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device

NCT ID: NCT01169272

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CRT-SonR 9770

Active implantable defibrillator with ability to cardiac resynchronization therapy

Group Type: EXPERIMENTAL

CRT-SonR 9770

Intervention Type: DEVICE

Active implantable defibrillator with capacity of cardiac resynchronization therapy

Interventions

CRT-SonR 9770

Active implantable defibrillator with capacity of cardiac resynchronization therapy

Intervention Type: DEVICE

Other Intervention Names

9770

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LivaNova

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe CL Leclercq, Ryhtmologist

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

Leclercq

Rennes, , France

Countries

France

Other Identifiers

SonR Study - ITSY05

Identifier Type: -

Identifier Source: org_study_id