Clinical Evaluation Of The SonR Atrial Lead In Paradym RF Device

NCT01169272 | Completed Phase 3

• 1 other identifier: SonR Study - ITSY05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

ICD CRT 9770 - PARADYM RF ICD - SonR atrial lead

Outcome Measures

Primary Outcomes (1)

• Evaluation of the SonR lead safety

  Complication free rate of the SonR lead superior to 90 %

  3 months

Secondary Outcomes (7)

• Incidence of adverse events

  12 months

• ICD electrical performances

  12 months

• Evaluation of the SonR atrial lead performance

  3 months

• Evaluation of the AV/VV delays optimization

  3 months

• Evaluation of the left ventricular lead performances

  12 months

Study Arms (1)

CRT-SonR 9770

EXPERIMENTAL

Active implantable defibrillator with ability to cardiac resynchronization therapy

Device: CRT-SonR 9770

Interventions

CRT-SonR 9770 DEVICE

Active implantable defibrillator with capacity of cardiac resynchronization therapy

Also known as: 9770

CRT-SonR 9770

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LivaNova: lead

Study Sites (1)

Leclercq

Rennes, 35033, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christophe CL Leclercq, Ryhtmologist

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2010
• First Posted: July 26, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2012
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

FR (1)