Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study

NCT00632372 | Completed DMC FDA Device

• 1 other identifier: 60015786
• Study Type: observational
• Target: 8
• Locations: 2 countries
• Sites: 10

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (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.

  12 months

Study Arms (1)

HeartPOD™ System with Cardiac Resynchronization Therapy

All patients will receive both a HeartPod device and a CRT-D device.

Device: Cardiac Resynchronization Therapy; Device: HeartPOD™ System

Interventions

Cardiac Resynchronization Therapy DEVICE

Pacing of the left ventricle to resynchronize ventricular contraction.

Also known as: CRT-D

HeartPOD™ System with Cardiac Resynchronization Therapy

HeartPOD™ System DEVICE

Left atrial pressure monitoring.

HeartPOD™ System with Cardiac Resynchronization Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with class III heart failure and a CRT-D device implanted.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (10)

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Sanger Clinic

Charlotte, North Carolina, 28203, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Medical Univserity of South Carolina

Charleston, South Carolina, 29403, United States

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Related Publications (1)

• Chan WY, Blomqvist A, Melton IC, Noren K, Crozier IG, Benser ME, Eigler NL, Gutfinger D, Troughton RW. Effects of AV delay and VV delay on left atrial pressure and waveform in ambulant heart failure patients: insights into CRT optimization. Pacing Clin Electrophysiol. 2014 Jul;37(7):810-9. doi: 10.1111/pace.12362. Epub 2014 Feb 6.

  PMID: 24502608 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Richard Troughton, MD

  Christchurch Hospital - Christchurch, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2008
• First Posted: March 10, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2015
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); US (9)