About MCVI | Foundation | Physicians | Locations | Specialty Services | Testing | Electrophysiology Research | Events | Job Opportunities | Patient Links | Referring Physicians | Articles

RIGHT TRIAL

Principal Investigator:
Liaqat Zaman, MD

Sub Investigators:
Nilofar Islam, MD
Rehan Mahmud, MD
Asim Yunus, MD

Sponsor:
Guidant Corporation (“Guidant”)

Study:  Rhythm ID Going Head-to-head Trial

Objective:  The Right trial is a randomized, prospective, two-arm study that will assess the differential efficacy of Guidant ICDs using Rhythm ID versus competitive Medtronic ICDs with Enhanced PR Logic or Wavelet discrimination algorithms.  Specifically, it will compare the incidence of inappropriate shocks.

Inclusion/Exclusion Criteria

Inclusion:

• Patients who meet current indications for ICD.
• Patients who sign and date a Patient Informed Consent form prior to the implant visit.
• Patients who remain in the clinical care of the enrolling physician in approved centers.
• Patients who are able to tolerate ICD programming as specifically prescribed in the protocol.

Exclusion:

• Patients who are in third degree heart block.
• Patients whose life expectancy is less than 12 months.
• Patients who have other cardiac surgeries or procedures planned but not yet performed during the duration of the study.
• Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study.  Each instance should be brought to the attention of Integra Clinical Trial Solutions (Integra CTS) to determine eligibility.
• Patients who are younger than 18 years of age.
• Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study.
• Patients who are pregnant or planned to become pregnant during the study.

Study Procedure: 

Patients are consented at the MCVI office only on an outpatient basis.  Patients will be randomized to either manufacturer’s ICD in a 1:1 ratio within dual and single chamber device subgroups.  All patients will be followed at 6 months, 12 months, and 6 month intervals thereafter post-implant until study closure.

Approved Devices:

Device Printouts

Please remember to submit all of the appropriate device printouts to Integra CTS. The printouts required include:

Implant/Pre-discharge Visit

• Pre-discharge programming parameters printout
• 10 second baseline rhythm printout
• Disk (Guidant devices only

Scheduled/Unscheduled Follow-up Visits

• Beginning of visit programming parameters printout
• Beginning of visit disk (Guidant devices only)
• 10 second baseline rhythm printout
• Episode list and EGMs of all episodes that receive treatment
• End of visit programming parameters printout
• End of visit disk (Guidant devices only) *for Guidant devices you will be submitting a total of 2 disks

**Please refer to the RIGHT Study Guide (pages 21-23) for printing instructions.
Call Integra CTS at 877-657-4448 if you have any questions.

Device Programming