HVAD: HW006 LATERAL Thoracotomy

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02268942
• Collaborator: INTERMACS (Other)
• Enrollment: 144
• Locations: 26
• Arm: 1
• Duration (Months): 47
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database.

All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.

Condition or Disease	Intervention/Treatment	Phase
Left Sided Heart Failure	Device: HeartWare HVAD; Procedure: Thoracotomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 144 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HeartWare HVAD via Thoracotomy HeartWare HVAD implanted via thoracotomy	Device: HeartWare HVAD; Implant of HeartWare HVAD via thoracotomy implant technique; Procedure: Thoracotomy; Thoracotomy implant technique

Outcome Measures

Primary Outcome Measures

1. Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months [6 months]

   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).

Secondary Outcome Measures

1. Mean Length of Initial Hospital Stay [Initial Hospital Stay]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry.

2. Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).

3. Subject signed an Intermacs® informed consent if required by local IRB policy.

4. Subject signed a HeartWare informed consent.

Exclusion Criteria:

1. Subject is incarcerated (prisoner).

2. Subject did not sign the informed consent at sites where waiver of consent was not granted.

3. Body Surface Area (BSA) < 1.2 m^2.

4. Prior cardiac transplant or cardiomyoplasty.

5. Subject is receiving a BiVAD.

6. Subject is receiving the device as an RVAD.

7. Subject data is generated from non- Intermacs® centers.

8. Pediatric subjects (< 19 years of age).

9. Subjects who receive a temporary LVAD

10. Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.

11. Severe Right Heart failure

12. Aortic insufficiency or mechanical aortic valve.

13. Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).

14. Known LV Thrombus.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama	Birmingham	Alabama	United States	35294
2	Stanford University School of Medicine	Palo Alto	California	United States	94305
3	UC San Diego	San Diego	California	United States	92093
4	UCSF Medical Center	San Francisco	California	United States	94143
5	Washington Hospital Center	Washington	District of Columbia	United States	20010
6	Tampa Transplant Institute/Tampa General Hospital	Tampa	Florida	United States	33606
7	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
8	Loyola University Medical Center	Maywood	Illinois	United States	60153
9	IU Health Methodist	Indianapolis	Indiana	United States	46202
10	St. Vincent Hospital	Indianapolis	Indiana	United States	46262
11	Jewish Hospital - Rudd Heart and Lung Institute	Louisville	Kentucky	United States	40202
12	John Ochsner Heart & Vascular Institute	New Orleans	Louisiana	United States	70115
13	Tufts Medical Center	Boston	Massachusetts	United States	02111
14	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109
15	Spectrum Health	Grand Rapids	Michigan	United States	49503
16	Mayo Rochester - St. Mary's Hospital	Rochester	Minnesota	United States	55905
17	St. Luke's Hospital of Kansas City	Kansas City	Missouri	United States	64111
18	Duke University Medical Center	Durham	North Carolina	United States	27710
19	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
20	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
21	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
22	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-8802
23	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
24	Virginia Commonwealth University	Richmond	Virginia	United States	23298-0068
25	University of Washington Medical Center	Seattle	Washington	United States	98195-6310
26	St. Paul's Hospital	Vancouver	British Columbia	Canada

Sponsors and Collaborators

• Medtronic Cardiac Rhythm and Heart Failure
• INTERMACS

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 24, 2018
• Statistical Analysis Plan - Feb 22, 2017

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• ClinicalTrials.gov Identifier: NCT02268942
• Other Study ID Numbers: HW006 Thoracotomy
• First Posted: Oct 20, 2014
• Last Update Posted: Dec 2, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	Per Protocol Population
Arm/Group Description	Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Period Title: Overall Study
STARTED	144
COMPLETED	144
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Per Protocol Population
Arm/Group Description	Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Overall Participants	144
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.2 (11.5)
Sex: Female, Male (Count of Participants)
Female	32 22.2%
Male	111 77.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 4.9%
Not Hispanic or Latino	132 91.7%
Unknown or Not Reported	5 3.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 2.1%
Asian	7 4.9%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	30 20.8%
White	90 62.5%
More than one race	3 2.1%
Unknown or Not Reported	11 7.6%
Region of Enrollment (participants) [Number]
Canada	3 2.1%
United States	141 97.9%
Height (centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [centimeters]	175.2 (8.8)
Weight (kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms]	83.5 (18.8)
Body Mass Index (kilograms per meters squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms per meters squared]	27.1 (5.1)
Body Surface Area (meters squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters squared]	2.0 (0.3)

Outcome Measures

1. Primary Outcome

Title	Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Per Protocol Population
Arm/Group Description	Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Measure Participants	143
Count of Participants [Participants]	128 88.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Per Protocol Population
	Comments	Success at six months is estimated to be 86% compared to a performance goal of 77.5%. Using an exact binomial test, with a one-sided alpha of 0.05, and 80% Power, a sample size of 145 implanted subjects was planned. Success will be met if the lower bound of the upper one-sided exact 95% confidence interval is greater than 77.5%.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0003
	Comments
	Method	Exact Binomial
	Comments

2. Secondary Outcome

Title	Mean Length of Initial Hospital Stay
Description	Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time
Time Frame	Initial Hospital Stay

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Per Protocol Population
Arm/Group Description	Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
Measure Participants	144
Mean (Standard Deviation) [days]	17.8 (11.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Per Protocol Population
	Comments	The secondary endpoint is an improvement in the mean length of initial hospital stay (initial recovery and step down unit), which is calculated by considering the number of days in acute care (ICU/CCU) plus the number of days in intermediate/step-down care, comprising the total number of days post-implant to discharge. This secondary endpoint will be calculated using an upper tail one-sided t-test at 0.05 level of significance compared to 26.1 days for median sternotomy patients.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Adverse Event Reporting Description	Intermacs Categories used for collection.
Arm/Group Title	Per Protocol Population
Arm/Group Description	Subjects meeting eligibility criteria and received an HVAD implanted via thoracotomy.
All Cause Mortality
	Per Protocol Population
	Affected / at Risk (%)	# Events
Total	20/144 (13.9%)
Serious Adverse Events
	Per Protocol Population
	Affected / at Risk (%)	# Events
Total	134/144 (93.1%)
Blood and lymphatic system disorders
Major Bleeding	46/144 (31.9%)	96
Hemolysis	60/144 (41.7%)
Cardiac disorders
Cardiac Arrhythmia	57/144 (39.6%)	85
Myocardial Infarction	0/144 (0%)	0
Right Heart Failure	53/144 (36.8%)
Arterial Non-CNS Thromboembolism	0/144 (0%)	0
Venous Thromboembolism	6/144 (4.2%)	6
General disorders
Hypertension	10/144 (6.9%)
Pericardial Fluid Collection	5/144 (3.5%)	5
Wound Dehiscence	3/144 (2.1%)	3
Hepatobiliary disorders
Hepatic Dysfunction	3/144 (2.1%)	3
Infections and infestations
Infection	66/144 (45.8%)	130
Product Issues
Device Malfunction/Failure and/or Pump Thrombus	42/144 (29.2%)	83
Psychiatric disorders
Psychiatric Episode	8/144 (5.6%)	8
Renal and urinary disorders
Renal Dysfunction	18/144 (12.5%)	20
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	18/144 (12.5%)	23
Vascular disorders
Neurological Dysfunction	38/144 (26.4%)	56
Other (Not Including Serious) Adverse Events
	Per Protocol Population
	Affected / at Risk (%)	# Events
Total	44/144 (30.6%)
General disorders
Other	44/144 (30.6%)	99

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.