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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00632372




Registration number
NCT00632372
Ethics application status
Date submitted
29/02/2008
Date registered
10/03/2008
Date last updated
4/02/2019

Titles & IDs
Public title
Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study
Scientific title
CRT-D Based Heart Failure Monitoring Study
Secondary ID [1] 0 0
60015786
Universal Trial Number (UTN)
Trial acronym
zLAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Cardiac Resynchronization Therapy
Treatment: Devices - HeartPOD™ System

Experimental: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
12 months

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
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
South Carolina
Country [8] 0 0
New Zealand
State/province [8] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00632372
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Troughton, MD
Address 0 0
Christchurch Hospital - Christchurch, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications