Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study (zLAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00632372
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : June 13, 2016
Information provided by (Responsible Party):
St. Jude Medical

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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Cardiac Resynchronization Therapy Device: HeartPOD™ System Phase 2

Detailed Description:

This is a multi-center feasibility study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CRT-D Based Heart Failure Monitoring Study
Study Start Date : January 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: HeartPOD™ System with Cardiac Resynchronization Therapy
All patients will receive both a HeartPod device and a CRT-D device.
Device: Cardiac Resynchronization Therapy
Pacing of the left ventricle to resynchronize ventricular contraction.
Other Name: CRT-D

Device: HeartPOD™ System
Left atrial pressure monitoring.

Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00632372

United States, California
University of Southern California
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Sanger Clinic
Charlotte, North Carolina, United States, 28203
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, South Carolina
Medical Univserity of South Carolina
Charleston, South Carolina, United States, 29403
New Zealand
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
St. Jude Medical
Principal Investigator: Richard Troughton, MD Christchurch Hospital - Christchurch, New Zealand

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: St. Jude Medical Identifier: NCT00632372     History of Changes
Other Study ID Numbers: 60015786
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases