Trial Outcomes & Findings for Medtronic Reveal XT Study (NCT NCT01526343)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

ILR monitoring obtained at 3, 6 and 12 months

Results posted on

2017-08-03

Participant Flow

A total of 47 consecutive patients who received an implantable loop recorder (ILR) after a surgical ablation procedure were followed between August 2011 and January 2014. Patients with AF who were scheduled to undergo elective surgical ablation procedure that included a CM IV lesion set or pulmonary vein isolation were eligible.

Participant milestones

Participant milestones
Measure	Reveal XT Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
Overall Study STARTED	47
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Medtronic Reveal XT Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reveal XT n=47 Participants Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
Age, Continuous	67 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: ILR monitoring obtained at 3, 6 and 12 months

Outcome measures

Outcome measures
Measure	Reveal XT n=47 Participants Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals Count of total ATAs	20,878 ATA episodes
Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals Count of reviewed and confirmed ATAs	1,034 ATA episodes

PRIMARY outcome

Timeframe: ILR monitoring at 12 months

Population: Participants with available data at 1 year and who were compliant with use of each device.

Outcome measures

Outcome measures
Measure	Reveal XT n=46 Participants Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
Freedom From Atrial Tachyarrhythmias (ATAs) Freedom from ATAs at 1 year, ILR device	37 Participants
Freedom From Atrial Tachyarrhythmias (ATAs) Freedom from ATAs at 1 year, Holter monitor	33 Participants
Freedom From Atrial Tachyarrhythmias (ATAs) Freedom from ATAs at 1 year, ECG	37 Participants

Adverse Events

Reveal XT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Bell, Manager of Clinical Trials

Washington University School of Medicine

Phone: 314-747-6969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place