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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00632372
First received: February 29, 2008
Last updated: June 9, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Heart Failure
Device: Cardiac Resynchronization Therapy
Device: HeartPOD™ System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CRT-D Based Heart Failure Monitoring Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: January 2008
Study Completion Date: December 2015
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

This is a multi-center feasibility study.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632372

Locations
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
Investigators
Principal Investigator: Richard Troughton, MD Christchurch Hospital - Christchurch, New Zealand
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00632372     History of Changes
Other Study ID Numbers: 60015786 
Study First Received: February 29, 2008
Last Updated: June 9, 2016
Health Authority: United States: Food and Drug Administration
New Zealand: Upper South B Regional Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2016