Clinical Evaluation Of The PARADYM RF Device

NCT01193634 | Completed Phase 3

• 1 other identifier: ITSY03 - PARADYM RF STUDY
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features: The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture. Then, the ICD devices have 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 VR 9250, DR 9550 and CRT 9750 - PARADYM RF ICD

Outcome Measures

Primary Outcomes (1)

• Demonstration of the Right ventricular (RV) autothreshold algorithm performances

  Demonstrate that the automatic RV pacing thresholds measures are equivalent to the manual test.

  1 month

Secondary Outcomes (4)

• Incidence of adverse events

  12 months

• ICD electrical performances

  12 months

• Evaluation of the left ventricular lead performances

  12 months

• Evlauation of the Remote Monitoring Solution

  12 months

Study Arms (1)

Paradym RF ICD

EXPERIMENTAL

Active implantable defibrillators range

Device: VR 9250 / DR 9550 / CRT 9750

Interventions

VR 9250 / DR 9550 / CRT 9750 DEVICE

Active implantable defibrillators range

Also known as: 9250 / 9550 / 9750

Paradym RF ICD

Eligibility Criteria

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

You may qualify if:

• In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of single-chamber ICD;
• In case of implantation of DR 9550: patient has been prescribed the implantation or replacement of a dual-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of dual-chamber ICD;
• In case of implantation of CRT 9750: patient has been prescribed the implantation or replacement of a triple-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC3 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of triple-chamber ICD;

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 ;
• Implanted pacemaker that is not going to be explanted or otherwise disabled;
• 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)

Sack

München, 80804, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sack SS Stefan, Pr

  Klinikum Schwabing München Germany

  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: August 31, 2010
• First Posted: September 2, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 18, 2014

Record last verified: 2014-06

Locations

DE (1)