Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00547729
• Collaborator: (none)
• Enrollment: 71
• Locations: 7
• Arm: 1
• Duration (Months): 39
• Patients Per Site: 10.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This study is a feasibility study of the HeartPOD™ Heart Failure Management System with DynamicRx® (HeartPOD system) in patients with severe chronic congestive heart failure. The device being studied in this trial monitors heart function and alerts the patient and physician of necessary changes to medication. The study will assess the safety, reliability, and preliminary efficacy of the HeartPOD™ system.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: HeartPOD™ System	N/A

Detailed Description

Direct cardiac measurements may provide an accurate, reliable and medically acceptable way of informing patients and physicians of worsening CHF prior to the development of symptoms. This may enable physicians to take preventative measures and avoid hospitalization.

This is a feasibility study to assess the safety, reliability, and preliminary efficacy of the HeartPOD™ Heart Failure Management System with DynamicRx®. This feasibility study will be performed in two phases. The first phase will enroll 20 patients at sites in Australia and New Zealand and the second phase will enroll 20 patients at sites in the U.S.

Study Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.
• Study Start Date: Mar 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HeartPOD™ System Implantation of HeartPOD™ Heart Failure Management System with DynamicRx®	Device: HeartPOD™ System; HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.

Outcome Measures

Primary Outcome Measures

1. Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks. [6 Weeks]

   Out of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 and < 85.

• Documented history of congestive heart failure resulting from ischemic or non-ischemic cardiomyopathy with systolic or diastolic dysfunction of at least 6 months duration.

• Patients with LVEF < 40% should receive maximally tolerated doses of ACE-I (or ARB if ACE-I is not tolerated), beta blockers, and anti-aldosterone therapy. The combination of hydralazine and nitrates should be considered in the persistently symptomatic African American patient.

• A history of NYHA Class II (OUS only), III or IV symptoms.

• Minimum of one (1) prior hospital admission within the last 12 months for exacerbation of CHF or one (1) presentation to the Emergency Department or Clinic requiring parenteral diuretic, vasodilator, inotrope, nesiritide, or equivalent treatment.

• Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.

• Central venous vascular access.

• Capable of Valsalva maneuver with airway pressure > 40 mm Hg for 10 seconds.

• The subject and the treating physician agree that the subject will comply with all required post-procedure follow-up, and that the patient is capable of correct device use as outlined in the protocol.

• Written informed consent.

Exclusion Criteria:

• Intractable HF with resting symptoms despite maximal medical therapy or active listing for cardiac transplantation (< 6 months survival expected).

• Resting systolic blood pressure < 90 or > 180 mmHg.

• Acute MI, unstable ischemic syndrome within the last 6 weeks.

• Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned within 6 weeks.

• Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy, amyloidosis or other infiltrative heart disease, constrictive, restrictive disease, tamponade, or moderate or large pericardial effusion.

• Subject has a history of deep venous thrombosis or pulmonary embolism.

• Surgical correction of congenital heart disease involving atrial septum.

• CVA or TIA within 6 months. History of uncorrected cerebral vascular disease.

• Atrial or ventricular thrombus, tumor or systemic thromboembolism.

• Chronic atrial fibrillation.

• Symptomatic bradyarrhythmia or sustained VT/VF unless successfully treated with cardiac rhythm management device for 6 weeks.

• Atrial septal defect or patent foramen ovale > 2 mm in diameter.

• Life expectancy < 1 year from malignancy, primary pulmonary hypertension, renal, hepatic, or neurological condition, etc.

• Gastrointestinal bleeding during the last 6 months.

• Coagulopathy or uninterruptible anticoagulation therapy or unable to take antiplatelet medications.

• Creatinine > 2.5 gm/dl

• Temperature > 37.8C or white blood cell count (WBC) > 13,000/mm3.

• The subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Green Hospital	La Jolla	California	United States	92037
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	The Ohio State University	Columbus	Ohio	United States	43210
4	Oklahoma Heart Hospital	Oklahoma City	Oklahoma	United States	73120
5	Alfred Hospital	Melbourne	Victoria	Australia	3004
6	University of Auckland	Auckland		New Zealand
7	Christchurch Hospital	Christchurch		New Zealand

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Study Chair: William T. Abraham, MD, FACC, Ohio State University
• Principal Investigator: Henry Krum, MD, Monash University/Alfred Hosptial

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ritzema J, Melton IC, Richards AM, Crozier IG, Frampton C, Doughty RN, Whiting J, Kar S, Eigler N, Krum H, Abraham WT, Troughton RW. Direct left atrial pressure monitoring in ambulatory heart failure patients: initial experience with a new permanent implantable device. Circulation. 2007 Dec 18;116(25):2952-9. Epub 2007 Dec 3.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00547729
• Other Study ID Numbers: HP-05-04/HP-12-04
• First Posted: Oct 23, 2007
• Last Update Posted: Sep 2, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Abbott Medical Devices: Heart Failure; Left Atrial Pressure Monitoring
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Pre-assignment Detail	A total of 71 subjects were enrolled. The adverse events (both serious and non-serious) during the entire period of the study were evaluated in 71 subjects.

Arm/Group Title	HeartPOD™ System
Arm/Group Description	Implantation of HeartPOD™ System HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
Period Title: Overall Study
STARTED	71
COMPLETED	71
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	HeartPOD™ System
Arm/Group Description	Implantation of HeartPOD™ System HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
Overall Participants	71
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.1 (10.9)
Sex: Female, Male (Count of Participants)
Female	19 26.8%
Male	52 73.2%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.
Description	Out of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke.
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HeartPOD™ System
Arm/Group Description	Implantation of HeartPOD™ System HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
Measure Participants	55
Count of Participants [Participants]	51 71.8%

Adverse Events

Time Frame	Subjects were followed for 12 months to evaluate adverse events.
Arm/Group Title	HeartPOD™ System
Arm/Group Description	Implantation of HeartPOD™ System HeartPOD™ System: HeartPOD™ device automatically measures left heart pressures throughout the day.
All Cause Mortality
	HeartPOD™ System
	Affected / at Risk (%)	# Events
Total	31/71 (43.7%)
Serious Adverse Events
	HeartPOD™ System
	Affected / at Risk (%)	# Events
Total	68/71 (95.8%)
Blood and lymphatic system disorders
Anemia	2/71 (2.8%)	2
False Positive Blood Cultures	1/71 (1.4%)	1
Hypokalemia	1/71 (1.4%)	1
Thromboemboli	1/71 (1.4%)	1
Cardiac disorders
Angina	14/71 (19.7%)	16
Angioplasty	1/71 (1.4%)	1
Atrial Fibrillation	1/71 (1.4%)	1
Atrial Fibrillation with RVR	1/71 (1.4%)	1
Atrioventricular block	2/71 (2.8%)	2
Chest Pain	4/71 (5.6%)	4
Heart Failure	35/71 (49.3%)	89
Myocardial Infarction	7/71 (9.9%)	10
Ventricular Fibrillation	2/71 (2.8%)	2
Ventricular Tachycardia	9/71 (12.7%)	14
Endocrine disorders
Hyperglycemia	2/71 (2.8%)	4
Hypoglycemia	2/71 (2.8%)	2
Gastrointestinal disorders
Antral gastritis	1/71 (1.4%)	1
Diarrhea	2/71 (2.8%)	3
Dyspnea	1/71 (1.4%)	1
Gastroenteritis	2/71 (2.8%)	2
Gastrointestinal Bleeding	1/71 (1.4%)	2
Hernia	1/71 (1.4%)	1
Melena	1/71 (1.4%)	1
Pleuritic chest pain	1/71 (1.4%)	1
General disorders
Body Tingling	1/71 (1.4%)	1
Chest Pain	2/71 (2.8%)	2
Death	31/71 (43.7%)	31
Dehydration	1/71 (1.4%)	1
Dizziness	1/71 (1.4%)	1
Esophageal Reflux	1/71 (1.4%)	1
Fall	2/71 (2.8%)	3
Fever	1/71 (1.4%)	1
Hypoxia	1/71 (1.4%)	1
Lightheadedness	1/71 (1.4%)	1
Pain	2/71 (2.8%)	3
Presyncope	3/71 (4.2%)	3
Stroke	2/71 (2.8%)	2
Syncope	10/71 (14.1%)	10
Hepatobiliary disorders
Cholecystitis	1/71 (1.4%)	1
Infections and infestations
Gastroenteritis	1/71 (1.4%)	1
Infection	7/71 (9.9%)	11
Iritis	1/71 (1.4%)	1
Osteomyelitis	1/71 (1.4%)	1
Sepsis	3/71 (4.2%)	3
Septic Shock	1/71 (1.4%)	1
Viral Syndrome	1/71 (1.4%)	1
Injury, poisoning and procedural complications
Acute hemorrhage/bleeding	3/71 (4.2%)	3
Air emboli	1/71 (1.4%)	1
Cardiac or venous perforation	1/71 (1.4%)	1
Dehydration	1/71 (1.4%)	1
Erosion	1/71 (1.4%)	1
Fall	3/71 (4.2%)	3
Hematoma/seroma formation	3/71 (4.2%)	4
Lead displacement	1/71 (1.4%)	1
Oversedation	1/71 (1.4%)	1
Pain	1/71 (1.4%)	1
Pericardial effusion	1/71 (1.4%)	1
Pneumothorax	1/71 (1.4%)	1
Right and Left Atrium Thrombus	1/71 (1.4%)	1
Investigations
Device migration	2/71 (2.8%)	2
Musculoskeletal and connective tissue disorders
Arthritis	1/71 (1.4%)	1
Chest Pain	1/71 (1.4%)	1
Fracture	1/71 (1.4%)	1
Osteoarthritis	1/71 (1.4%)	1
Pain	1/71 (1.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	5/71 (7%)	7
Nervous system disorders
Pain	1/71 (1.4%)	1
Syncope	2/71 (2.8%)	2
Product Issues
Device malfunction	8/71 (11.3%)	8
Fidelis Medtronic RV lead impedance out of range	1/71 (1.4%)	1
Inappropriate ICD Shocks	1/71 (1.4%)	1
Lead Failure	1/71 (1.4%)	1
Pacemaker Mediated Tachycardia	1/71 (1.4%)	2
Sensor Drift	1/71 (1.4%)	1
Psychiatric disorders
Trauma	1/71 (1.4%)	1
Renal and urinary disorders
Prostatism	1/71 (1.4%)	1
Renal Failure	7/71 (9.9%)	9
Ureteral Stricture and Dilatation	1/71 (1.4%)	1
Urinary Retension	1/71 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Bronchitis	2/71 (2.8%)	2
Chronic obstructive pulmonary disease	1/71 (1.4%)	2
Pneumonia	3/71 (4.2%)	3
Pulmonary edema	1/71 (1.4%)	2
Skin and subcutaneous tissue disorders
Abscess	2/71 (2.8%)	2
Surgical and medical procedures
Atrial Pressure Sensor Revision	1/71 (1.4%)	1
AV Fistula Creation for Dialysis	1/71 (1.4%)	1
Balloon Cystoscopy	1/71 (1.4%)	1
Chemotherapy	1/71 (1.4%)	1
Hysterectomy	1/71 (1.4%)	1
LVAD Repair	1/71 (1.4%)	1
Percutaneous Mitral Repair	1/71 (1.4%)	1
Planned CRT implant	4/71 (5.6%)	4
Planned CRT replacement	1/71 (1.4%)	1
Planned Device Revision	1/71 (1.4%)	1
Planned ICD Implant	1/71 (1.4%)	1
Planned LVAD Implant	1/71 (1.4%)	1
Planned Pacemaker Replacement	1/71 (1.4%)	1
Planned Pulse Generator Replacement	1/71 (1.4%)	1
Planned Upgrade to CRT	1/71 (1.4%)	2
Surgery	2/71 (2.8%)	3
Vascular disorders
Carotid Stenosis	1/71 (1.4%)	1
Cerebrovascular Accident	2/71 (2.8%)	2
Coronary artery disease	2/71 (2.8%)	2
Deep Vein Thrombosis	1/71 (1.4%)	2
Hypotension	5/71 (7%)	5
Stroke	2/71 (2.8%)	2
Transient Ischemic Attack	2/71 (2.8%)	2
Other (Not Including Serious) Adverse Events
	HeartPOD™ System
	Affected / at Risk (%)	# Events
Total	45/71 (63.4%)
Blood and lymphatic system disorders
Anemia	1/71 (1.4%)	1
Epistaxis	1/71 (1.4%)	1
Hyperkalemia	1/71 (1.4%)	1
Cardiac disorders
Angina	2/71 (2.8%)	2
Chest Pain	2/71 (2.8%)	2
Heart failure	4/71 (5.6%)	5
Endocrine disorders
Hyperglycemia	1/71 (1.4%)	1
Eye disorders
Blurred Vision	1/71 (1.4%)	1
Gastrointestinal disorders
Nausea	3/71 (4.2%)	3
General disorders
Abdominal Bruising	1/71 (1.4%)	1
Dehydration	1/71 (1.4%)	1
Episode of Vagueness	1/71 (1.4%)	1
Fatigue	1/71 (1.4%)	1
Headache	1/71 (1.4%)	1
Pain	1/71 (1.4%)	1
Syncope	3/71 (4.2%)	3
Hepatobiliary disorders
Elevated liver enzymes	1/71 (1.4%)	1
Infections and infestations
Infection	4/71 (5.6%)	4
Injury, poisoning and procedural complications
Acute hemorrhage/bleeding	8/71 (11.3%)	8
Device migration	2/71 (2.8%)	2
Discomfort at device location	1/71 (1.4%)	1
Hematoma/seroma formation	8/71 (11.3%)	8
Infection	1/71 (1.4%)	1
Nausea	1/71 (1.4%)	1
Oversedation	1/71 (1.4%)	1
Pain	1/71 (1.4%)	1
Skin injury	1/71 (1.4%)	1
Wound Dehiscence	1/71 (1.4%)	1
Wound Tenderness	1/71 (1.4%)	1
Investigations
Abnormal lab results	1/71 (1.4%)	1
Musculoskeletal and connective tissue disorders
Pain	1/71 (1.4%)	1
Nervous system disorders
Femoral Nerve Irritation	1/71 (1.4%)	1
Hypotension	1/71 (1.4%)	1
Pain	1/71 (1.4%)	1
Paresthesia	1/71 (1.4%)	1
Vasovagal Episode	1/71 (1.4%)	1
Product Issues
Bradycardia due to ICD RV lead dislodgement	1/71 (1.4%)	1
Device Malfunction	2/71 (2.8%)	2
Renal and urinary disorders
Renal Failure	1/71 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Bronchitis	1/71 (1.4%)	1
Skin and subcutaneous tissue disorders
Dermatitis	1/71 (1.4%)	1
Surgical and medical procedures
Cholecystectomy	1/71 (1.4%)	1
Elective Cataract Surgery	1/71 (1.4%)	1
Lightheadedness during Valsalva	1/71 (1.4%)	1
Planned Knee Replacement	2/71 (2.8%)	2
Surgery	2/71 (2.8%)	3
Vascular disorders
Hypotention	1/71 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.