Tricuspid RegurgitationPLACENCT05667519
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
A study testing Additional guidance of lead implantation by transesophageal echocardiography in people with Tricuspid Regurgitation and Pacemaker Complication, run by LMU Klinikum at 1 site in Germany.
Trial summary
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation, Pacemaker Complication
- What is being tested?
- Additional guidance of lead implantation by transesophageal echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- indication for right ventricular lead implantation according to current guidelines
Who cannot join
- preexisting tricuspid regurgitation ≥ grade 2
- other severe heart valve disease
- history of tricuspid valve treatment
- preexisting right ventricular lead
- chronic dialysis
- contraindication for transesophageal echocardiography
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
LMU Klinikum
Munich, Bavaria, 81377
Daniel Braun, Prof. Dr.
About this study
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.
Read the detailed description
Lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations for heart failure. Transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years. Echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines.
- Conditions
- Tricuspid Regurgitation, Pacemaker Complication
- Being tested
- Additional guidance of lead implantation by transesophageal echocardiography
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional guidance of lead implantation by transesophageal echocardiographyProcedure or surgery
Transesophageal echocardiography guidance of lead implantation targeting a stable lead position in a tricuspid valve commissure (preferentially postero-septal) and an apical ventricular lead position
| Study group | Role | What they receive |
|---|---|---|
| Transesophageal echocardiography + fluoroscopy guided lead implantation | Experimental | TEE will be done in addition to fluoroscopy to guide lead implantation. Receives: Procedure: Additional guidance of lead implantation by transesophageal echocardiography |
| Fluoroscopy guided lead implantation | No intervention | Fluoroscopy only will be used to guide lead implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening of tricuspid regurgitation by at least one grade
Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines
Measured: Mean follow up of 2 years
Secondary outcomes (7)
Death and cardiovascular death
All cause death and cardiovascular death
Measured: Mean follow up of 2 years
Heart failure hospitalizations
Unplanned hospitalizations for heart failure
Measured: Mean follow up of 2 years
Duration of procedure and radiation
Standard parameters affecting quality of device implantation
Measured: Mean follow up of 2 years
Right ventricular function and geometry as assessed by transthoracic echocardiography
Right ventricular function (TAPSE, fractional area change, 3D volumetry) and geometry as assessed by transthoracic echocardiography
Measured: Mean follow up of 2 years
Sensing, Pacing and RV-stimulation of the right ventricular lead
Sensing, Pacing and RV-stimulation of the right ventricular lead in the pacemaker readout
Measured: Mean follow up of 2 years
Change in functional capacity as assessed NYHA classification
New York Heart Association (NYHA) Functional Classification
Measured: Mean follow up of 2 years
Change in quality of life as assessed by MLHFQ
Minnesota Living with Heart Failure Questionnaire
Measured: Mean follow up of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Oct 2022
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMU Klinikum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Braun, MD, LMU Klinikum
- Investigators
- Daniel Braun, MD, Principal investigator, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667519
- Sponsor's protocol ID
- PLACE
- Acronym
- PLACE
- Status last verified
- Dec 2022
- First submitted
- 2 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)
- ClinicalTrials.gov ID
- NCT05667519
- Acronym / sponsor ID
- PLACE / PLACE
- Conditions
- Tricuspid Regurgitation, Pacemaker Complication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Dec 2022 (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.
This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years.
Detailed description
Lead-induced tricuspid regurgitation is a frequent complication after pacemaker- and ICD-implantation that is associated with increased mortality and hospitalizations for heart failure. Transesophageal echocardiography has shown to be a safe and feasible way to guide right ventricular lead placement and was associated with less worsening of tricuspid regurgitation than standard lead implantation in a small study with a retrospective control group. This is the first randomized controlled trial comparing transesophageal echocardiography + fluoroscopy guided lead implantation vs. standard lead implantation guided by fluoroscopy only. Patients are randomized 1:1 in the two groups and followed up for up to 3 years. Echocardiographic grading of the primary endpoint will be performed by a blinded echocardiographer according to current guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transesophageal echocardiography + fluoroscopy guided lead implantation | Experimental | Procedure: Additional guidance of lead implantation by transesophageal echocardiographyTEE will be done in addition to fluoroscopy to guide lead implantation. |
| Fluoroscopy guided lead implantation | No intervention | –Fluoroscopy only will be used to guide lead implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for right ventricular lead implantation according to current guidelines
Key exclusion criteria (6 listed)
- preexisting tricuspid regurgitation ≥ grade 2
- other severe heart valve disease
- history of tricuspid valve treatment
- preexisting right ventricular lead
- chronic dialysis
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 |
|---|---|---|
| Additional guidance of lead implantation by transesophageal echocardiographyTransesophageal echocardiography guidance of lead implantation targeting a stable lead position in a tricuspid valve commissure (preferentially postero-septal) and an apical ventricular lead position | Procedure or surgery | Transesophageal echocardiography + fluoroscopy guided lead implantation |
Primary outcome
Worsening of tricuspid regurgitation by at least one grade
Time frame: Mean follow up of 2 years
Worsening of tricuspid regurgitation by at least one grade on transthoracic echocardiography according to current guidelines
7 secondary outcomes
Death and cardiovascular death
Time frame: Mean follow up of 2 years
Heart failure hospitalizations
Time frame: Mean follow up of 2 years
Duration of procedure and radiation
Time frame: Mean follow up of 2 years
Right ventricular function and geometry as assessed by transthoracic echocardiography
Time frame: Mean follow up of 2 years
Sensing, Pacing and RV-stimulation of the right ventricular lead
Time frame: Mean follow up of 2 years
Change in functional capacity as assessed NYHA classification
Time frame: Mean follow up of 2 years
Change in quality of life as assessed by MLHFQ
Time frame: Mean follow up of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Daniel Braun, MD principal investigator
LMU Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional guidance of lead implantation by transesophageal echocardiography in people with Tricuspid Regurgitation and Pacemaker Complication, run by LMU Klinikum at 1 site in Germany.
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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Dec 2022. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Braun, MD (+4989440072371, daniel.braun@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worsening of tricuspid regurgitation by at least one grade (time frame: Mean follow up of 2 years). 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 28 Dec 2022.