Heart FailureNCT03850808
LV Dysfunction Following Pacemaker Placement
An observational study of Heart Failure, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Several studies have confirmed the link between chronic RV apical pacing and the development of heart failure and LV systolic dysfunction in some patients 1,2. However, questions continue to remain unanswered in regard to the adverse effects of RV pacing such as the exact amount of RV pacing that is detrimental to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have undergone permanent pacemaker placement for AV node dysfunction
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: The Incidence of Left Ventricular Dysfunction Following Pacemaker Placement: Differential Effects of Intrinsic AV Node Disease v. AV Node Ablation.
Several studies have confirmed the link between chronic RV apical pacing and the development of heart failure and LV systolic dysfunction in some patients 1,2. However, questions continue to remain unanswered in regard to the adverse effects of RV pacing such as the exact amount of RV pacing that is detrimental to cardiac function and which subsets of patients are most at risk for developing cardiac dysfunction from chronic RV pacing. Rates of permanent pacemaker implantation have been increased over the last twenty years with expanding indications to include permanent pacing after AV node ablation for the treatment of drug refractory atrial fibrillation and other atrial tachy-arrhythmias. The current standard of practice is to minimize RV pacing however in patients that have had an AV node ablation right ventricular pacing cannot be avoided therefore it is important to identify if this particular group of patients is at an increased risk for developing worsening cardiac function. The purpose of this study is to compare cardiac function over time between patients that have undergone AV node ablation versus patients that have had pacemaker implantation for AV node dysfunction.
Read the detailed description
Study Design This is a retrospective chart review of patients that have undergone permanent pacemaker implantation by the electrophysiology group at Oregon Health and Sciences University Hospital during the period between 01/2003 and 01/2013 for chronic RV pacing after AV node ablation or for AV node dysfunction.
Goal The goal of this study is to determine if patients requiring RV pacing after AV nodal ablation are at increased risk for developing worsening cardiac function secondary to chronic RV pacing compared to patients requiring RV pacing for AV node dysfunction.
Specific Objectives
- To determine the number of patients that have a permanent pacemaker implanted after AV node ablation and for AV node dysfunction within the last 10 years at OHSU Hospital.
- To determine the number of patients that have a biventricular pacemaker implanted with or without an implantable cardiac defibrillator within the last 10 years at OHSU Hospital (control group).
- Amongst those patients identified determine (1) left ventricular ejection fraction prior to permanent pacemaker or biventricular pacemaker implantation and over time (2) left ventricular volume and/or diameter prior to permanent pacemaker placement and over time (3) all cause mortality
- Amongst those patients identified determine incidence of new onset atrial fibrillation after permanent pacemaker or biventricular pacemaker implantation
- Amongst those patients identified determine incidence of inpatient admission of heart failure exacerbation defined as presenting symptoms of dyspnea, orthopnea, paroxysmal nocturnal dyspnea, increased lower extremity edema requiring IV diuretics
Methods
This is a retrospective chart review of patients that have undergone permanent pacemaker medical record system used at OHSU Hospital) with the help of an EPIC representative. If the patient was referred for permanent pacemaker or biventricular pacemaker implantation from a physician or medical group outside of OHSU records will be requested from that physician or medical group.
- Conditions
- Heart Failure
- Keywords
- heart failure, permanent pacemaker, AV node dysfunction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| decline in left ventricular function | This group will be patients in whom a decline in left ventricular systolic function was found. | |
| preserved left ventricular function | This group will consist of patients in whom left ventricular systolic function is preserved. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Systolic Function
This is a chart review to see if left ventricular systolic function changed after placement of a permanent pacemaker. Changed is defined as 10 percentage points of left ventricular ejection fraction.
Measured: 3 month and 1 year followup, if available (this is a chart review)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study startSep 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Henrikson, MD, Oregon Health and Science University
- Investigators
- Charles Henrikson, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850808
- Sponsor's protocol ID
- PPMLV-9879
- Status last verified
- Feb 2019
- First submitted
- 25 Sep 2013
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Left Ventricular Dysfunction Following Pacemaker Placement: Differential Effects of Intrinsic AV Node Disease v. AV Node Ablation.
- ClinicalTrials.gov ID
- NCT03850808
- Acronym / sponsor ID
- PPMLV-9879
- Conditions
- Heart Failure
- Keywords
- heart failure, permanent pacemaker, AV node dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 22 Feb 2019 (actual)
- 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.
Several studies have confirmed the link between chronic RV apical pacing and the development of heart failure and LV systolic dysfunction in some patients 1,2. However, questions continue to remain unanswered in regard to the adverse effects of RV pacing such as the exact amount of RV pacing that is detrimental to cardiac function and which subsets of patients are most at risk for developing cardiac dysfunction from chronic RV pacing. Rates of permanent pacemaker implantation have been increased over the last twenty years with expanding indications to include permanent pacing after AV node ablation for the treatment of drug refractory atrial fibrillation and other atrial tachy-arrhythmias. The current standard of practice is to minimize RV pacing however in patients that have had an AV node ablation right ventricular pacing cannot be avoided therefore it is important to identify if this particular group of patients is at an increased risk for developing worsening cardiac function. The purpose of this study is to compare cardiac function over time between patients that have undergone AV node ablation versus patients that have had pacemaker implantation for AV node dysfunction.
Detailed description
Study Design This is a retrospective chart review of patients that have undergone permanent pacemaker implantation by the electrophysiology group at Oregon Health and Sciences University Hospital during the period between 01/2003 and 01/2013 for chronic RV pacing after AV node ablation or for AV node dysfunction.
Goal The goal of this study is to determine if patients requiring RV pacing after AV nodal ablation are at increased risk for developing worsening cardiac function secondary to chronic RV pacing compared to patients requiring RV pacing for AV node dysfunction.
Specific Objectives
- To determine the number of patients that have a permanent pacemaker implanted after AV node ablation and for AV node dysfunction within the last 10 years at OHSU Hospital.
- To determine the number of patients that have a biventricular pacemaker implanted with or without an implantable cardiac defibrillator within the last 10 years at OHSU Hospital (control group).
- Amongst those patients identified determine (1) left ventricular ejection fraction prior to permanent pacemaker or biventricular pacemaker implantation and over time (2) left ventricular volume and/or diameter prior to permanent pacemaker placement and over time (3) all cause mortality
- Amongst those patients identified determine incidence of new onset atrial fibrillation after permanent pacemaker or biventricular pacemaker implantation
- Amongst those patients identified determine incidence of inpatient admission of heart failure exacerbation defined as presenting symptoms of dyspnea, orthopnea, paroxysmal nocturnal dyspnea, increased lower extremity edema requiring IV diuretics
Methods
This is a retrospective chart review of patients that have undergone permanent pacemaker medical record system used at OHSU Hospital) with the help of an EPIC representative. If the patient was referred for permanent pacemaker or biventricular pacemaker implantation from a physician or medical group outside of OHSU records will be requested from that physician or medical group.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decline in left ventricular function | – | –This group will be patients in whom a decline in left ventricular systolic function was found. |
| preserved left ventricular function | – | –This group will consist of patients in whom left ventricular systolic function is preserved. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have undergone permanent pacemaker placement for AV node dysfunction
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left Ventricular Systolic Function
Time frame: 3 month and 1 year followup, if available (this is a chart review)
This is a chart review to see if left ventricular systolic function changed after placement of a permanent pacemaker. Changed is defined as 10 percentage points of left ventricular ejection fraction.
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 Feb 2019.
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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.
Charles Henrikson, MD principal investigator
Oregon Health and Science University
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 Heart Failure, run by Oregon Health and Science University 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 0 inclusion and 1 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 Feb 2019. 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.
What does the primary outcome measure?
Left Ventricular Systolic Function (time frame: 3 month and 1 year followup, if available (this is a chart review)). It is what the study was designed to measure, not a finding.
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 Feb 2019.