Chronic Heart FailureNCT00288288
Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures
An observational study of Chronic Heart Failure, run by University of Kansas at 1 site in United States.
Trial summary
The primary purpose of this study is to compare the time, risk and cost savings of 2 patient groups who receive FDA approved left ventricular pacing leads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Epicardial left ventricular lead placement and Transvenous left ventricular lead implant
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to May 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical Center
Who may be able to join
- Left ventricular ejection fraction < or = 35%
- QRS duration greater than or = to 120ms
- NYHA Functional Class 3 or 4
- Age > or = to 18 years
Who cannot join
- No previous pacemaker or ICD implant
- No permanent atrial fibrillation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
The primary purpose of this study is to compare the time, risk and cost savings of 2 patient groups who receive FDA approved left ventricular pacing leads.
Read the detailed description
The purpose of this study is to: a) examine the usefulness of placing an epicardial LV lead at the time of open chest surgery in patients who are likely to benefit from a CRT system following their surgery; b) compare differences between patients who receive LV leads using the transvenous approach and those patients who receive LV leads using the epicardial approach; and c) assess the cost effectiveness of placing the LV lead via the transvenous versus the epicardial approaches.
- Conditions
- Chronic Heart Failure
- Being tested
- Epicardial left ventricular lead placement, Transvenous left ventricular lead implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epicardial left ventricular lead placementProcedure or surgery
Epicardial left ventricular lead placement
Transvenous left ventricular lead implantProcedure or surgery
Transvenous left ventricular lead implant
| Study group | Role | What they receive |
|---|---|---|
| 1 | Epicardial left ventricular lead placement during a clinically indicated open chest surgery Receives: Procedure: Epicardial left ventricular lead placement | |
| 2 | Transvenous left ventricular lead implant during a clinically indicated CRT system implant Receives: Procedure: Transvenous left ventricular lead implant |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startMar 2006
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Loren Berenbom, MD, University of Kansas
- Investigators
- Loren Berenbom, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288288
- Sponsor's protocol ID
- PROPEL
- Status last verified
- Sep 2012
- First submitted
- 3 Feb 2006
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Epicardial LV Leads Placed During Cardiac Surgery Procedures
- ClinicalTrials.gov ID
- NCT00288288
- Acronym / sponsor ID
- PROPEL
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Mar 2006
- Study completion
- May 2010 (actual)
- First posted
- 7 Feb 2006 (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 primary purpose of this study is to compare the time, risk and cost savings of 2 patient groups who receive FDA approved left ventricular pacing leads.
Detailed description
The purpose of this study is to: a) examine the usefulness of placing an epicardial LV lead at the time of open chest surgery in patients who are likely to benefit from a CRT system following their surgery; b) compare differences between patients who receive LV leads using the transvenous approach and those patients who receive LV leads using the epicardial approach; and c) assess the cost effectiveness of placing the LV lead via the transvenous versus the epicardial approaches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Epicardial left ventricular lead placementEpicardial left ventricular lead placement during a clinically indicated open chest surgery |
| 2 | – | Procedure: Transvenous left ventricular lead implantTransvenous left ventricular lead implant during a clinically indicated CRT system implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical Center
Key inclusion criteria (4 listed)
- Left ventricular ejection fraction < or = 35%
- QRS duration greater than or = to 120ms
- NYHA Functional Class 3 or 4
- Age > or = to 18 years
Key exclusion criteria (2 listed)
- No previous pacemaker or ICD implant
- No permanent atrial fibrillation
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 |
|---|---|---|
| Epicardial left ventricular lead placementEpicardial left ventricular lead placement | Procedure or surgery | 1 |
| Transvenous left ventricular lead implantTransvenous left ventricular lead implant | Procedure or surgery | 2 |
Primary outcome
Not reported in the source record.
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 25 Sep 2012.
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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.
Loren Berenbom, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by University of Kansas at 1 site in United States.
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 4 inclusion and 2 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 25 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Where can I read the original study information?
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 25 Sep 2012.