Trial Outcomes & Findings for RIGHT: Rhythm ID Going Head-to-Head Trial (NCT NCT00148954)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1962 participants

Primary outcome timeframe

From date of pre-discharge until a minimum of 12 months follow-up until study closure

Results posted on

2012-01-12

Participant Flow

Participant milestones

Participant milestones
Measure	VITALITY 2 VITALITY 2 ICD	Medtronic Family Selected Medtronic family devices
Overall Study STARTED	985	977
Overall Study COMPLETED	678	677
Overall Study NOT COMPLETED	307	300

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RIGHT: Rhythm ID Going Head-to-Head Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VITALITY 2 n=985 Participants VITALITY 2 ICD	Medtronic Family n=977 Participants Selected Medtronic family devices	Total n=1962 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	489 Participants n=93 Participants	482 Participants n=4 Participants	971 Participants n=27 Participants
Age, Categorical >=65 years	496 Participants n=93 Participants	495 Participants n=4 Participants	991 Participants n=27 Participants
Age Continuous	64.3 years STANDARD_DEVIATION 12.4 • n=93 Participants	64.4 years STANDARD_DEVIATION 12.0 • n=4 Participants	64.3 years STANDARD_DEVIATION 12.2 • n=27 Participants
Sex: Female, Male Female	223 Participants n=93 Participants	197 Participants n=4 Participants	420 Participants n=27 Participants
Sex: Female, Male Male	762 Participants n=93 Participants	780 Participants n=4 Participants	1542 Participants n=27 Participants
Region of Enrollment United States	915 participants n=93 Participants	909 participants n=4 Participants	1824 participants n=27 Participants
Region of Enrollment Europe	65 participants n=93 Participants	63 participants n=4 Participants	128 participants n=27 Participants
Region of Enrollment Canada	5 participants n=93 Participants	5 participants n=4 Participants	10 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	VITALITY 2 n=985 Participants VITALITY 2 ICD	Medtronic Family n=977 Participants Selected Medtronic family devices
Number of Patients With Inappropriate Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Therapy (Shock or Antitachycardia Pacing [ATP]) After the Pre-Discharge Visit	246 Participants	187 Participants

SECONDARY outcome

Timeframe: Time of event

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of event

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time of event

Outcome measures

Outcome data not reported

Adverse Events

VITALITY 2

Serious events: 0 serious events

Other events: 535 other events

Deaths: 0 deaths

Medtronic Family

Serious events: 0 serious events

Other events: 508 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	VITALITY 2 n=985 participants at risk This study did not collect serious adverse events	Medtronic Family n=977 participants at risk This study did not collect serious adverse events
Cardiac disorders Pulse generator Related	3.4% 33/985 • Number of events 33	2.1% 21/977 • Number of events 21
Cardiac disorders Right atrial lead related	1.8% 18/985 • Number of events 25	1.1% 11/977 • Number of events 11
Cardiac disorders Right ventricular lead related	4.9% 48/985 • Number of events 57	6.1% 60/977 • Number of events 77
Cardiac disorders Procedure related	3.0% 30/985 • Number of events 32	2.6% 25/977 • Number of events 26
Cardiac disorders Cardiovascular related	41.6% 410/985 • Number of events 769	38.2% 373/977 • Number of events 690
Cardiac disorders Other	19.3% 190/985 • Number of events 303	17.8% 174/977 • Number of events 239

Additional Information

Greg Voss, Clinical Director

Boston Scientific

Phone: 651-581-3068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place