Heart FailurezLAPNCT00632372
Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study
An observational study of Heart Failure, run by Abbott Medical Devices at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Resynchronization Therapy and HeartPOD™ System
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jan 2008to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with class III heart failure and a CRT-D device implanted.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical Univserity of South Carolina
Charleston, South Carolina, 29403
Sanger Clinic
Charlotte, North Carolina, 28203
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: CRT-D Based Heart Failure Monitoring Study
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.
Read the detailed description
This is a multi-center feasibility study.
.
- Conditions
- Heart Failure
- Being tested
- Cardiac Resynchronization Therapy, HeartPOD™ System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization TherapyDevice
Also called CRT-D
Pacing of the left ventricle to resynchronize ventricular contraction.
HeartPOD™ SystemDevice
Left atrial pressure monitoring.
| Study group | Role | What they receive |
|---|---|---|
| HeartPOD™ System with Cardiac Resynchronization Therapy | All patients will receive both a HeartPod device and a CRT-D device. Receives: Device: Cardiac Resynchronization Therapy; Device: HeartPOD™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionSep 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Troughton, MD, Principal investigator, Christchurch Hospital - Christchurch, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632372
- Sponsor's protocol ID
- 60015786
- Acronym
- zLAP
- Status last verified
- Oct 2020
- First submitted
- 29 Feb 2008
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24502608
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRT-D Based Heart Failure Monitoring Study
- ClinicalTrials.gov ID
- NCT00632372
- Acronym / sponsor ID
- zLAP / 60015786
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartPOD™ System with Cardiac Resynchronization Therapy | – | Device: Cardiac Resynchronization Therapy, Device: HeartPOD™ SystemAll patients will receive both a HeartPod device and a CRT-D device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with class III heart failure and a CRT-D device implanted.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Resynchronization TherapyAlso: CRT-DPacing of the left ventricle to resynchronize ventricular contraction. | Device | HeartPOD™ System with Cardiac Resynchronization Therapy |
| HeartPOD™ SystemLeft atrial pressure monitoring. | Device | HeartPOD™ System with Cardiac Resynchronization Therapy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Derived from this study: PubMed 24502608Chan 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.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Troughton, MD principal investigator
Christchurch Hospital - Christchurch, New Zealand
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Abbott Medical Devices at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.