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Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study | Clinical Trials | Clareo Health

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Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study

CRT-D Based Heart Failure Monitoring Study

NCT00632372•Abbott Medical Devices

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.

Detailed Description

This is a multi-center feasibility study. .

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

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.
+11 more criteria

Locations (10)

University of Southern California

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Rochester Medical Center

Rochester, New York, United States

Sanger Clinic

Charlotte, North Carolina, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, United States

Medical Univserity of South Carolina

Charleston, South Carolina, United States

Christchurch Hospital

Christchurch, New Zealand

Key Dates

Start Date

January 1, 2008

Primary Completion Date

September 1, 2011

Completion Date

December 1, 2015

Last Updated

October 12, 2020

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

DEVICE

HeartPOD™ System

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study

Inclusion Criteria

Exclusion Criteria

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