Trial Outcomes & Findings for Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD) (NCT NCT01446796)

Results Overview

To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

14 days

Results posted on

2015-03-10

Participant Flow

One subject provided initial consent but withdrew his consent prior to undergoing left ventricular assist device implantation. No further research activities for the study were performed with respect to this subject.

Participant milestones

Participant milestones
Measure	Continuous RV Pacing Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (\>80%) of paced right ventricular beats	Native Conduction Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
Overall Study STARTED	3	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuous RV Pacing Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (\>80%) of paced right ventricular beats	Native Conduction Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Right Ventricular (RV) Pacing in Early Post-operative Continuous Flow Left Ventricular Assist Device (LVAD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous RV Pacing n=3 Participants Study terminated early due to recruitment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	68 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Study terminated early

To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Population: Study terminated early due to low accrual. No data analysis completed.

To determine whether continuous RV pacing reduces the need for inotropic / vasoactive agents, mechanical ventilation, or other circulatory support in the early post-operative period. Measured by the number of hemodynamic and respiratory support interventions and duration of those interventions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Population: Study terminated early due to low accrual. No data analysis completed.

To determine whether continuous RV pacing improves invasive and non-invasive measures of RV function in the early period post-LVAD implantation. Measured by Pulmonary Artery catheter measures of intra-cardiac pressures and cardiac output in the ICU setting and by qualitative and quantitative Echocardiographic measures of RV function during the hospital course.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

Population: Study terminated early due to low accrual. No data analysis completed.

To determine whether continuous RV pacing improves functional capacity and symptoms as measured by six minute walk test and symptoms questionnaires in the early post-LVAD implantation period.

Outcome measures

Outcome data not reported

Adverse Events

Native Conduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Continuous RV Pacing

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

Michel Khouri, MD

Duke University Medical Center

Phone: 919 684 8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place