Trial Outcomes & Findings for Identifying and Facilitating Ventricular Recovery on Mechanical Support (NCT NCT00687856)

Results Overview

Noninvasive determination of left ventricular function using novel echocardiographic imaging methods and routine clinical assessments to optimize markers of left ventricular recovery. These markers would determine LVAD patients with cardiac recovery who no longer needed LVAD support.

Recruitment status

COMPLETED

Target enrollment

211 participants

Primary outcome timeframe

Number of participants who had LV recovery and LVAD explant over 3 years.

Results posted on

2023-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	LVAD Recipients Participants who have had or are about to have a left ventricular assist device (LVAD) implanted Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts.
Overall Study STARTED	211
Overall Study COMPLETED	211
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Identifying and Facilitating Ventricular Recovery on Mechanical Support

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LVAD Recipients n=211 Participants Participants who have had or are about to have a left ventricular assist device (LVAD) implanted Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	211 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 23 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants
Region of Enrollment United States	211 participants n=5 Participants

PRIMARY outcome

Timeframe: Number of participants who had LV recovery and LVAD explant over 3 years.

Population: The outcome measured were the number of patients who had cardiac recovery and who no longer required LVAD support and had successful LVAD explant. Of 211 LVAD recipients, there were 8 who had successful LVAD explant

Noninvasive determination of left ventricular function using novel echocardiographic imaging methods and routine clinical assessments to optimize markers of left ventricular recovery. These markers would determine LVAD patients with cardiac recovery who no longer needed LVAD support.

Outcome measures

Outcome measures
Measure	LVAD Recipients n=211 Participants Participants who have had or are about to have a left ventricular assist device (LVAD) implanted Echocardiogram (echo): Participants will undergo a series of echoes to determine if they are eligible to be weaned from LVAD support. Each echo exam will involve the use of an ultrasound probe on the chest of participants to assess the pumping ability of their hearts.
Number of Subjects With Left Ventricular Recovery and LVAD Explant	8 Participants

SECONDARY outcome

Timeframe: Measured at Year 3

Outcome measures

Outcome data not reported

Adverse Events

LVAD Recipients

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

John Gorcsan MD

University of Pittsburgh

Phone: 4126476570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place