TachycardiaPhase 4NCT00148954

RIGHT: Rhythm ID Going Head-to-Head Trial

A Phase 4 study testing VITALITY 2 Implantable Cardioverter Defibrillator and Medtronic Implantable Cardioverter Defibrillator in people with Tachycardia, run by Boston Scientific Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected Medtronic ICDs. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Tachycardia
What is being tested?: VITALITY 2 Implantable Cardioverter Defibrillator and Medtronic Implantable Cardioverter Defibrillator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,962 participants
Where: 1 siteUnited States
Study dates: Jul 2005to Jul 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who meet current indications for an 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 study protocol

Who cannot join

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
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 plan to become pregnant during the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Rhythm ID Going Head-to-head Trial

Read the detailed description

RIGHT will compare the incidence of Ventricular Tachycardia/Fibrillation (VT/VF) therapies delivered for Supraventricular Tachycardia (SVT) episodes using VITALITY 2 devices with Rhythm ID™ to that of ICDs employing other rhythm discrimination algorithms. Appropriateness of therapies will be assessed after independent adjudication of all VT/VF events leading to therapy. Comparisons will be made between device manufacturers across patient populations receiving either a dual- or single-chamber device.

Conditions: Tachycardia
Being tested: VITALITY 2 Implantable Cardioverter Defibrillator, Medtronic Implantable Cardioverter Defibrillator
Medical subject headings: Tachycardia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VITALITY 2 Implantable Cardioverter DefibrillatorDevice
VITALITY 2 ICD
Medtronic Implantable Cardioverter DefibrillatorDevice
Maximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD

Study groups in NCT00148954
Study group	Role	What they receive
Implantable Cardioverter Defibrillator - Boston Scientific	Active comparator	VITALITY 2 ICD Receives: Device: VITALITY 2 Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator - Medtronic	Active comparator	Selected Medtronic family ICD Receives: Device: Medtronic Implantable Cardioverter Defibrillator

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.
Measured: From date of pre-discharge until a minimum of 12 months follow-up until study closure

Secondary outcomes (3)

Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)
Measured: Time of event
Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)
Measured: Time of event
Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode
Measured: Time of event

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2005Jul 2010

First posted8 Sep 2005 (estimated)
Study startJul 2005
Primary completionMar 2009
Study completionJul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TachycardiaStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,962 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00148954
Sponsor's protocol ID: CR-CA-032105-T
Other IDs: RIGHT
Status last verified: Jan 2012
First submitted: 6 Sep 2005
Last updated: 12 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Berger RD, Lerew DR, Smith JM, Pulling C, Gold MR. The Rhythm ID Going Head to Head Trial (RIGHT): design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators. J Cardiovasc Electrophysiol. 2006 Jul;17(7):749-53. doi: 10.1111/j.1540-8167.2006.00463.x.
PubMed 16836672
Gold MR, Ahmad S, Browne K, Berg KC, Thackeray L, Berger RD. Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: primary results of the Rhythm ID Going Head to Head Trial. Heart Rhythm. 2012 Mar;9(3):370-7. doi: 10.1016/j.hrthm.2011.10.004. Epub 2011 Oct 4.
PubMed 21978966

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
Postural Tachycardia Syndrome
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy

All Tachycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Rhythm ID Going Head-to-head Trial
ClinicalTrials.gov ID: NCT00148954
Acronym / sponsor ID: CR-CA-032105-T
Conditions: Tachycardia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,962 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Mar 2009 (actual)
Study completion: Jul 2010 (actual)
First posted: 8 Sep 2005 (estimated)
Results: Posted 26 Dec 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Implantable Cardioverter Defibrillator - Boston Scientific	Active comparator	Device: VITALITY 2 Implantable Cardioverter DefibrillatorVITALITY 2 ICD
Implantable Cardioverter Defibrillator - Medtronic	Active comparator	Device: Medtronic Implantable Cardioverter DefibrillatorSelected Medtronic family ICD

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients who meet current indications for an 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 study protocol

Key exclusion criteria (7 listed)

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
Patients who are younger than 18 years of age

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VITALITY 2 Implantable Cardioverter DefibrillatorVITALITY 2 ICD	Device	Implantable Cardioverter Defibrillator - Boston Scientific
Medtronic Implantable Cardioverter DefibrillatorMaximo, Marquis, Intrinsic, Virtuoso, or Entrust ICD	Device	Implantable Cardioverter Defibrillator - Medtronic

Primary outcome

Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit
Time frame: From date of pre-discharge until a minimum of 12 months follow-up until study closure
An inappropriate therapy is defined as a VT/VF therapy, either shock or antitachycardia pacing (ATP), delivered for a supraventricular tachycardia (SVT). All events for which a VT/VF therapy was delivered and a stored electrogram exists were reviewed by an independent adjudication committee to determine the appropriateness of device rhythm classification and subsequent therapy delivery.

3 secondary outcomes

Time to First Inappropriate Shock Using VITALITY and Selected Medtronic Implantable Cardioverter Defibrillator (ICDs)
Time frame: Time of event
Positive Predictive Value (PPV) of Ventricular Tachycardia/Fibrillation (VT/VF) Discrimination Algorithms Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillators (ICDs)
Time frame: Time of event
Time to First Inappropriate Therapy for Which the Discrimination Algorithm Found in VITALITY 2 and Medtronic Implantable Cardioverter Defibrillator (ICDs) Inappropriately Classified the Episode
Time frame: Time of event

Results and safety

Results posted to the registry on 26 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VITALITY 2	985	678
Medtronic Family	977	677

Primary outcome: Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit

Time frame: From date of pre-discharge until a minimum of 12 months follow-up until study closure. Number. Unit: Participants

Measure	VITALITY 2 n = 985	Medtronic Family n = 977
Value	246	187

VITALITY 2 vs Medtronic Family: Hazard Ratio (HR): 1.34 (95% CI 1.11 to 1.62), p = 0.003, Regression, Cox

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VITALITY 2	0 of 0	535 of 985 (54.3%)	Not reported
Medtronic Family	0 of 0	508 of 977 (52%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16836672Berger RD, Lerew DR, Smith JM, Pulling C, Gold MR. The Rhythm ID Going Head to Head Trial (RIGHT): design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators. J Cardiovasc Electrophysiol. 2006 Jul;17(7):749-53. doi: 10.1111/j.1540-8167.2006.00463.x.
Derived from this study: PubMed 21978966Gold MR, Ahmad S, Browne K, Berg KC, Thackeray L, Berger RD. Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: primary results of the Rhythm ID Going Head to Head Trial. Heart Rhythm. 2012 Mar;9(3):370-7. doi: 10.1016/j.hrthm.2011.10.004. Epub 2011 Oct 4.

Related trials for Tachycardia

Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Ultrasound Guided Stellate Ganglion Block in Postural Tachycardia Syndrome
Postural Tachycardia Syndrome
Not yet recruiting
MRI-guided Ventricular Tachycardia Ablation in Patients With Structural Heart Disease
Ventricular Tachycardia (VT), Ischemic Cardiomyopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Gold, MD, PhD principal investigator

Medical University of South Carolina

Ron Berger, MD, PhD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit (time frame: From date of pre-discharge until a minimum of 12 months follow-up until study closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00148954, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2012.