Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00632372

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 and HeartPOD® system	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	CRT Based Heart Failure Monitoring Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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 ]

Estimated Enrollment:	12
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental All patients will receive both a HeartPod device and a CRT-D device.	Device: Cardiac resynchronization therapy and HeartPOD® system Devices automatically collect data which is downloaded by the physician at regular office visits.

Detailed Description:

This is a single center feasibility study.

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Eligibility

Ages Eligible for Study:	18 Years to 85 Years
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 or CRT-P.

Alternatively, the patient may already have in place a CRT-D or CRT-P device that requires a generator change.

In addition, the patient may be already enrolled in HOMEOSTASIS I and completed the 12-month follow-up.

Central venous vascular access.
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 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 < 80 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.
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 > 2.5 gm/dl (220 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.

Contacts and Locations

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

Locations

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

No publications provided

Responsible Party:	St. Jude Medical, CRMD ( Director, Clinical Affairs )
Study ID Numbers:	60015786
Study First Received:	February 29, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00632372 History of Changes
Health Authority:	New Zealand:Upper South B Regional Ethics Committee

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009