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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00632372
Registration number
NCT00632372
Ethics application status
Date submitted
29/02/2008
Date registered
10/03/2008
Date last updated
12/10/2020
Titles & IDs
Public title
Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study
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Scientific title
CRT-D Based Heart Failure Monitoring Study
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Secondary ID [1]
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60015786
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Universal Trial Number (UTN)
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Trial acronym
zLAP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Cardiac Resynchronization Therapy
Treatment: Devices - HeartPOD™ System
HeartPOD™ System with Cardiac Resynchronization Therapy - All patients will receive both a HeartPod device and a CRT-D device.
Treatment: Devices: Cardiac Resynchronization Therapy
Pacing of the left ventricle to resynchronize ventricular contraction.
Treatment: Devices: HeartPOD™ System
Left atrial pressure monitoring.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Determine which heart failure monitoring feature acquired by the CRT device correlates most closely with simultaneously measured left ventricular filling pressure, as measured by left atrial pressure.
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Assessment method [1]
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Timepoint [1]
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12 months
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Eligibility
Key inclusion criteria
- Age > 18 and = 85.
- Have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D.
Alternatively, the patient may already have in place an existing Promote CRT-D or
other SJM CRT device with similar functions, or have a CRT-D device that requires a
generator change. In addition, the patient may be already enrolled in HOMEOSTASIS I or
II and completed the 12-month follow-up.
- Central venous vascular access.
- Have a legally marketed right atrial bipolar pacing lead, a right ventricular bipolar
defibrillation lead, and a left ventricular bipolar pacing lead.
- Demonstrate capability of Valsalva maneuver with airway pressure > 40 mm Hg for =10
seconds.
- The subject and the treating physician agree that the subject is geographically stable
and willing to comply with all required post-procedure follow-up, and that the patient
is capable of correct device use as outlined in the protocol.
- The subject has been informed of the nature of the study and agrees to its provisions
and has provided written informed consent as approved by the Institutional Review
Board or Ethics Committee of the respective clinical site
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Intractable HF with resting symptoms despite maximal medical therapy (AHA/ACC Stage D)
or active listing for cardiac transplantation (<6 months survival expected).
- Resting systolic blood pressure < 90 or > 180 mm Hg.
- Acute Myocardial Infarction (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 within the last
6 months.
- Surgical correction of congenital heart disease involving atrial septum that will
prevent safe implantation of the SJM HeartPOD ISL.
- Cerebral Vascular Accident (CVA) or Transient Ischemic Attacks (TIA's) within the last
6 months. History of uncorrected cerebral vascular disease.
- Atrial or ventricular thrombus, tumor or systemic thromboembolism.
- Atrial septal defect or clinically significant patent foramen ovale.
- Life expectancy less than one 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 > 2.4 gm/dl (212 µmol/L) at enrollment.
- Active systemic infection.
- 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.
- Have a contraindication for an emergency thoracotomy
- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or
short term contact with heparin.
- Positive pregnancy test at enrollment or planning a pregnancy in the next 12 months.
- Patient is pacemaker dependent, where cessation of pacemaker function consistently
results in syncope or ventricular asystole.
- Incompatible previously implanted intracardiac devices.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2015
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Sample size
Target
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Massachusetts
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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South Carolina
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Country [8]
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New Zealand
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State/province [8]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Abbott Medical Devices
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to collect and analyze electrical measurements, timing, and
signals from a CRT-D device in heart failure patients who either already have an implanted
left atrial pressure sensor or will undergo a simultaneous implantation of a left atrial
pressure sensor and a CRT-D device. These devices may be placed at the same time or
separately (staged procedure) at the discretion of the investigator. A comparison will be
made between the information gathered from the CRT-D system and the information gathered by
the left atrial pressure sensor.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00632372
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Richard Troughton, MD
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Address
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Christchurch Hospital - Christchurch, New Zealand
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00632372
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