Trial Outcomes & Findings for Study of New Implantable Loop Recorder (NCT NCT00746564)

Results Overview

The sensitivity was calculated for each recording and for each subject.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

75 participants

Primary outcome timeframe

6 weeks

Results posted on

2019-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	SJM Confirm Device All patients in this study received the St. Jude Medical (SJM Confirm device.
Overall Study STARTED	75
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SJM Confirm Device All patients in this study received the St. Jude Medical (SJM Confirm device.
Overall Study Required Pacemaker/ICD Implant	2

Baseline Characteristics

Study of New Implantable Loop Recorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=75 Participants All patients who were implanted with the SJM Confirm device.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I were included in this analysis. Total patients 48; 50-(1 withdrawal)-(1 patient with recording lacking the surface channel). Total analyzable recordings 88; 89-(1 recording lacking visible R waves).

The sensitivity was calculated for each recording and for each subject.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=48 Participants All patients in this study received the SJM Confirm device.
Sensitivity for R Waves During In-Clinic Recordings at Rest	100 percentage of recordings Interval 100.0 to 100.0

PRIMARY outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 46; 50-(1 withdrawal)-(1 patient's recording lacking surface ECG channel)-(2 no recording obtained). Total analyzable recordings =39; 46 obtained-(7 with zero visible R waves).

The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=39 Clinical Recordings All patients in this study received the SJM Confirm device.
Sensitivity for R Waves During In-Clinic Recordings During Treadmill Exercise	98.1 percentage of recordings Interval 95.7 to 100.0

PRIMARY outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 82; 96 obtained-(14 recordings with zero visible R waves)=82 recordings

The sensitivity for R waves during the in-clinic recordings was was calculated for each recording and for each subject.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=82 Clinical Recordings All patients in this study received the SJM Confirm device.
Sensitivity for R Waves During In-Clinic Recordings During Hand to Hand/Shoulder Maneuvers	98.0 percentage of recordings Interval 95.5 to 100.0

PRIMARY outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient with no recording obtained). Total analyzable recordings 89.

The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=89 Clinical Recordings All patients in this study received the SJM Confirm device.
Positive Predictive Value (PPV) for In-Clinic Recordings at Rest	98.9 percentage of recordings Interval 96.7 to 100.0

PRIMARY outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 45; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel)-(2 patients where no recording was obtained). Total analyzable recordings 45: 46 obtained-(1 recording with zero visible R waves).

The positive predictive value (PPV) for the in-clinic recording was calculated for each recording and for each subject.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=45 Clinical recordings All patients in this study received the SJM Confirm device.
Positive Predictive Value (PPV) for In-Clinic Recordings During Treadmill Stress Test	77.1 percentage of recordings Interval 65.9 to 88.4

PRIMARY outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 48; 50-(1 withdrawal)-(1 patient recording lacking surface ECG channel). Total analyzable recordings 92: 96 obtained-(4 recordings with zero visible R waves)

The positive predictive value (PPV) for the in-clinic recording was was calculated for each recording and for each subject.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=92 Clinical Recordings All patients in this study received the SJM Confirm device.
Positive Predictive Value (PPV) During Hand to Hand/Shoulder Maneuvers	85.0 percentage of recordings Interval 78.3 to 91.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 30; 50-(1 withdrawal)-(19 patients who did not initiate recordings). Total analyzable recordings 58.

The proportion of recording time during which the device recording was interpretable was calculated for each weekly Patient Activator recording and for each subject. A random effects model was fitted to the data.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=58 Clinical Recordings All patients in this study received the SJM Confirm device.
Interpretability of Weekly Subject Activator Recordings	99.2 percentage of interpretable recordings Interval 98.5 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes). Total analyzable recordings 2804.

The proportion of recording time during which the device recording was interpretable for each automatically triggered/symptom driven recording and for each subject.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=2804 Recordings All patients in this study received the SJM Confirm device.
Interpretability of Automatically Triggered/Symptom Driven Recordings	92.3 percentage of interpretable recordings Interval 91.9 to 92.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: 50 patients implanted with the SJM Confirm device in Phase I. Total patients 47; 50-(1 withdrawal)-(2 patients whose recordings were lost due to programming changes).

The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a generalized estimating equation (GEE) model for binomial outcomes to account for multiple recordings per patient.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=2741 Recordings All patients in this study received the SJM Confirm device.
Inappropriateness of Automatically Triggered Recordings - Phase I	86.2 percentage of inappropriate recordings Interval 79.4 to 91.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks

Population: All patients implanted with the SJM Confirm device in participating in Phase II. Total patients 36: (19 rollovers from Phase I enrollments)+(25 Phase II enrollments)-(1 withdrawal)-(7 subjects with no automatically triggered recordings). Total recordings obtained: 958

The proportion of automatically triggered recordings that were inappropriate (i.e. noise triggered)was calculated and reported using a GEE model for binomial outcomes to account for multiple recordings per patient.

Outcome measures

Outcome measures
Measure	SJM Confirm Device n=958 Recording All patients in this study received the SJM Confirm device.
Inappropriateness of Automatically Triggered Recordings - Phase II	62.3 percentage of inappropriate recordings Interval 48.1 to 76.2

Adverse Events

SJM Confirm Device

Serious events: 11 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SJM Confirm Device n=75 participants at risk All patients in this study received the SJM Confirm device.
Surgical and medical procedures PREMATURE BATTERY DEPLETION/ ICM	13.3% 10/75 • Number of events 10 • Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years. Patients were assessed for adverse events, and the Confirm device was evaluated at each study visit.
Surgical and medical procedures DEVICE EXTRUSION	1.3% 1/75 • Number of events 1 • Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years. Patients were assessed for adverse events, and the Confirm device was evaluated at each study visit.
Surgical and medical procedures VAGAL REACTION	1.3% 1/75 • Number of events 1 • Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years. Patients were assessed for adverse events, and the Confirm device was evaluated at each study visit.

Other adverse events

Other adverse events
Measure	SJM Confirm Device n=75 participants at risk All patients in this study received the SJM Confirm device.
Surgical and medical procedures EARLY BATTERY DEPLETION/ PATIENT ACTIVATOR	5.3% 4/75 • Number of events 4 • Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years. Patients were assessed for adverse events, and the Confirm device was evaluated at each study visit.
Surgical and medical procedures Excessive Noise on the EGM Resulting in Inability to Interpret the EGM	9.3% 7/75 • Number of events 12 • Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years. Patients were assessed for adverse events, and the Confirm device was evaluated at each study visit.
Surgical and medical procedures Undersensing	12.0% 9/75 • Number of events 14 • Baseline, 6-Week, 3-Month, and every 6 Months for the duration of the study or up to 5 years. Patients were assessed for adverse events, and the Confirm device was evaluated at each study visit.

Additional Information

Director, Clinical Studies

St. Jude Medical

Phone: 1-800-733-3455

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60