Trial Outcomes & Findings for HW006 LATERAL Thoracotomy (NCT NCT02268942)

Last Updated: 2019-12-02

Results Overview

* Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event).

Recruitment status

COMPLETED

Study phase

Target enrollment

144 participants

Primary outcome timeframe

6 months

Results posted on

2019-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Per Protocol Population Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Overall Study STARTED	144
Overall Study COMPLETED	144
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 subject refused to answer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Per Protocol Population n=144 Participants Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Age, Continuous	54.2 years STANDARD_DEVIATION 11.5 • n=144 Participants
Sex: Female, Male Female	32 Participants n=143 Participants • 1 subject refused to answer
Sex: Female, Male Male	111 Participants n=143 Participants • 1 subject refused to answer
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=144 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=144 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=144 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=144 Participants
Race (NIH/OMB) Asian	7 Participants n=144 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=144 Participants
Race (NIH/OMB) Black or African American	30 Participants n=144 Participants
Race (NIH/OMB) White	90 Participants n=144 Participants
Race (NIH/OMB) More than one race	3 Participants n=144 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=144 Participants
Region of Enrollment Canada	3 participants n=144 Participants
Region of Enrollment United States	141 participants n=144 Participants
Height	175.2 centimeters STANDARD_DEVIATION 8.8 • n=144 Participants
Weight	83.5 kilograms STANDARD_DEVIATION 18.8 • n=144 Participants
Body Mass Index	27.1 kilograms per meters squared STANDARD_DEVIATION 5.1 • n=144 Participants
Body Surface Area	2.0 meters squared STANDARD_DEVIATION 0.3 • n=144 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Per Protocol Population n=143 Participants Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months	128 Participants

SECONDARY outcome

Timeframe: Initial Hospital Stay

Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time

Outcome measures

Outcome measures
Measure	Per Protocol Population n=144 Participants Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Mean Length of Initial Hospital Stay	17.8 days Standard Deviation 11.7

Adverse Events

Per Protocol Population

Serious events: 134 serious events

Other events: 44 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	Per Protocol Population n=144 participants at risk Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Blood and lymphatic system disorders Major Bleeding	31.9% 46/144 • Number of events 96 Intermacs Categories used for collection.
Cardiac disorders Cardiac Arrhythmia	39.6% 57/144 • Number of events 85 Intermacs Categories used for collection.
Product Issues Device Malfunction/Failure and/or Pump Thrombus	29.2% 42/144 • Number of events 83 Intermacs Categories used for collection.
Blood and lymphatic system disorders Hemolysis	41.7% 60/144 Intermacs Categories used for collection.
Infections and infestations Infection	45.8% 66/144 • Number of events 130 Intermacs Categories used for collection.
Cardiac disorders Myocardial Infarction	0.00% 0/144 Intermacs Categories used for collection.
Vascular disorders Neurological Dysfunction	26.4% 38/144 • Number of events 56 Intermacs Categories used for collection.
Cardiac disorders Right Heart Failure	36.8% 53/144 Intermacs Categories used for collection.
Hepatobiliary disorders Hepatic Dysfunction	2.1% 3/144 • Number of events 3 Intermacs Categories used for collection.
General disorders Hypertension	6.9% 10/144 Intermacs Categories used for collection.
General disorders Pericardial Fluid Collection	3.5% 5/144 • Number of events 5 Intermacs Categories used for collection.
Psychiatric disorders Psychiatric Episode	5.6% 8/144 • Number of events 8 Intermacs Categories used for collection.
Renal and urinary disorders Renal Dysfunction	12.5% 18/144 • Number of events 20 Intermacs Categories used for collection.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	12.5% 18/144 • Number of events 23 Intermacs Categories used for collection.
Cardiac disorders Arterial Non-CNS Thromboembolism	0.00% 0/144 Intermacs Categories used for collection.
Cardiac disorders Venous Thromboembolism	4.2% 6/144 • Number of events 6 Intermacs Categories used for collection.
General disorders Wound Dehiscence	2.1% 3/144 • Number of events 3 Intermacs Categories used for collection.

Other adverse events

Other adverse events
Measure	Per Protocol Population n=144 participants at risk Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
General disorders Other	30.6% 44/144 • Number of events 99 Intermacs Categories used for collection.

Additional Information

Mary Jacoski

Medtronic Cardiac Rhythm and Heart Failure

Phone: +15087390909

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In most cases, the contract allows the principal investigator to publish their data after the release of the multi-center publication (or one year after the conclusion of the study if no multi-center publication is submitted) following the sponsor review for (a) disclosure of confidential information, and (b) information that would impair the sponsor's ability to obtain patent protection.
Publication restrictions are in place

Restriction type: OTHER