Trial Outcomes & Findings for Reveal In-Office Implants (NCT NCT01168427)

NCT ID: NCT01168427

Last Updated: 2018-02-28

Results Overview

This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.

• Recruitment status: COMPLETED
• Target enrollment: 66 participants
• Primary outcome timeframe: From Implant to 90 days post-implant procedure
• Results posted on: 2018-02-28

Participant Flow

Participant milestones

Measure	Enrollment Cohort Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
Overall Study STARTED	66
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Enrollment Cohort Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
Overall Study Patient exited prior to implant	1

Baseline Characteristics

Reveal In-Office Implants

Baseline characteristics by cohort

Measure	Enrollment Cohort n=66 Participants Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	59.9 years STANDARD_DEVIATION 17.98 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Region of Enrollment United States	66 participants n=5 Participants

PRIMARY outcome

Timeframe: From Implant to 90 days post-implant procedure

Population: Reveal device indicated patients, enrolled in the study and implanted per protocol

This objective estimates the proportion of patients having procedure-related complication requiring resolution by surgical intervention at 90 days post-implant procedure using Kaplan-Meier method.

Outcome measures

Measure	Implant Cohort n=65 Participants Patient with Reveal device implanted
Procedure-related Complications Rate Requiring Resolution by Surgical Intervention	2 participants

SECONDARY outcome

Timeframe: From Implant to 90 days post-implant procedure

Report number of participants having procedure-related adverse events that meet the primary endpoint (requiring surgical intervention), and number of participants having other procedure-related adverse events (not requiring surgical intervention).

Outcome measures

Measure	Implant Cohort n=65 Participants Patient with Reveal device implanted
Number of Participants Having Procedure-related Adverse Events AEs that meet the primary endpoint	2 participants
Number of Participants Having Procedure-related Adverse Events Other procedure-related AEs	4 participants

SECONDARY outcome

Timeframe: At implant

Observational analysis of surgical staff present at the Reveal Implants

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At implant

Observational data collection as to the technics and procedures utilized during all implants including (but not limited to): device orientation, suturing, wound closure, instrument and material use, and time.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At implant

Observational survey of physicians satisfaction post implant At implant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Implant procedure and 30 days post-implant procedure

Average R-wave amplitude at implant and 30-days post procedure

Outcome measures

Outcome data not reported

Adverse Events

Implant Cohort

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Implant Cohort n=65 participants at risk Patient with Reveal device implanted
Skin and subcutaneous tissue disorders Allergic	3.1% 2/65 • Number of events 2 • From Implant to 90 days post-implant procedure
Infections and infestations Adverse event require surgical intervention	3.1% 2/65 • Number of events 2 • From Implant to 90 days post-implant procedure
Infections and infestations Adverse event resolved by oral antibiotics	3.1% 2/65 • Number of events 2 • From Implant to 90 days post-implant procedure

Additional Information

RIO Clinical Research Specialist.

Medtronic - CRDM

Phone: 1-800-328-2518

Email: MedtronicCRMtrials@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place