Trial Outcomes & Findings for Sensor Optimization of Cardiac Resynchronization Therapy Response (NCT NCT01832493)

Results Overview

Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

During implant

Results posted on

2016-08-29

Participant Flow

Patient recruitment occurred from September 27, 2013 to January 28, 2016.

Eight patients exited the study prior to undergoing the research procedure: Four did not meet inclusion/exclusion criteria; In 2 cases, the physician deemed withdrawal medically necessary; and in 2 cases, the surgeon was unable to place the left ventricular (LV) lead.

Participant milestones

Participant milestones
Measure	Cardiac Resynchronization Therapy Patients All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Overall Study STARTED	50
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Cardiac Resynchronization Therapy Patients All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Overall Study Physician Decision	2
Overall Study Protocol Violation	4
Overall Study Unable to place LV lead	2

Baseline Characteristics

Sensor Optimization of Cardiac Resynchronization Therapy Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac Resynchronization Therapy Patients n=42 Participants All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Age, Continuous	63.1 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Region of Enrollment Canada	18 participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants
Region of Enrollment Hong Kong	11 participants n=5 Participants

PRIMARY outcome

Timeframe: During implant

Population: Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all AV intervals of interest.

Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. Intracardiac impedance is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by intracardiac impedance agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max.

Outcome measures

Outcome measures
Measure	Cardiac Resynchronization Therapy n=28 Participants Patients implanted with a cardiac resynchronization therapy device Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
AV Interval Determination Using Impedance	14 participants

PRIMARY outcome

Timeframe: During implant

Population: Patients with a RV tripolar S1 Amplitude Transition measurement and a LV dP/dT max measurement for all AV intervals of interest.

Current practices use the measurement LV dP/dt max to determine how the AV interval should be programmed in a CRT device. A heart sounds measure, called S1 Amplitude Transition, is another method that could be used to determine the optimal AV interval. This outcome measure is the number of patients where the optimal AV interval setting as determined by heart sounds agrees within one AV interval setting (30 milliseconds) of the optimal setting determined by LV dP/dt max

Outcome measures

Outcome measures
Measure	Cardiac Resynchronization Therapy n=26 Participants Patients implanted with a cardiac resynchronization therapy device Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
AV Interval Determination Using Heart Sounds	11 participants

PRIMARY outcome

Timeframe: During implant

Population: Patients with a RV tripolar intracardiac impedance measurement and a LV dP/dT max measurement for all electrode configurations of interest.

Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Intracardiac impedance is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by intracardiac impedance agrees with the optimal setting determined by LV dP/dt max

Outcome measures

Outcome measures
Measure	Cardiac Resynchronization Therapy n=31 Participants Patients implanted with a cardiac resynchronization therapy device Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Optimal Electrode Configuration Determination Using Impedance	8 participants

PRIMARY outcome

Timeframe: During implant

Population: Patients with a RV tripolar S1 amplitude measurement and a LV dP/dT max measurement for all electrode configurations of interest.

Current practices use the measurement LV dP/dt max to determine how the optimal electrode configuration for a CRT device. Heart sounds, as measured by S1 Amplitude, is another method that could be used to determine the optimal electrode configuration. This outcome measure is the number of patients where the optimal electrode configuration setting as determined by heart sounds agrees with the optimal setting determined by LV dP/dt max

Outcome measures

Outcome measures
Measure	Cardiac Resynchronization Therapy n=28 Participants Patients implanted with a cardiac resynchronization therapy device Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
Optimal Electrode Configuration Determination Using Heart Sounds	12 participants

Adverse Events

All Enrolled Patients

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Patients n=50 participants at risk Adverse events were collected and are reported for all 50 enrolled patients
General disorders Device Stimulation Issue	2.0% 1/50 • Number of events 1 • During implant to 26 days post-implant
Immune system disorders Anaphylactic Shock	2.0% 1/50 • Number of events 1 • During implant to 26 days post-implant
Cardiac disorders Myocardial Infarction	2.0% 1/50 • Number of events 1 • During implant to 26 days post-implant

Other adverse events

Adverse event data not reported

Additional Information

Medtronic SOCR Clinical Trial Leader

Medtronic CRHF

Phone: 1-800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60