Tricuspid Valve InsufficiencyPLACENCT04945005
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
An observational study of Tricuspid Valve Insufficiency and Pacemaker Complication, run by LMU Klinikum at 1 site in Germany.
Trial summary
Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Valve Insufficiency, Pacemaker Complication, Echocardiography, Transesophageal
- What is being tested?
- Transesophageal guidance of lead implantation
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to 31 Dec 2020
- How long will I take part?
- 12 Months
- 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: All adult patients undergoing pacemaker/ICD implantation including a transtricuspid lead were included in this registry.
Who may be able to join
- indication for pacemaker/ICD implantation including a transtricuspid lead according to guidelines
Who cannot join
- pre-existing RV lead
- pre-existing TR >2
Trial locations and contacts
1 site in 1 country.
About this study
Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.
Read the detailed description
Lead induced tricuspid regurgitation is a common finding after pacemaker/ICD Implantation. Transesophageal echocardiography (TEE) might be used to guide lead implantations in order to prevent tricuspid regurgitation.
In this registry, patients undergoing pacemaker/ICD implantation including a transtricuspid lead are enrolled. While in most patients lead implantation is guided by fluroscopy, in some patients lead implantation is guided by TEE in addition to fluroscopy.
Aims of this registry: Evaluation of
- Incidence of lead induced tricuspid regurgitation
- Mortality and morbidity of lead induced tricuspid regurgitation
- Identification of risk factors for lead induced tricuspid regurgitation
- Influence of the lead position within the tricuspid valve on the incidence of lead induced tricuspid regurgitation
- Prevention of lead induced tricuspid regurgitation by TEE-guided lead implantation
- Being tested
- Transesophageal guidance of lead implantation
- 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.
Transesophageal guidance of lead implantationProcedure or surgery
In patients undergoing lead implantation including transesophageal echocardiography for clinical reasons (e.g. intraprocedural cardioversion), echocardiography was also used for guidance of lead implantation to reduce lead-leaflet interactions
| Study group | Role | What they receive |
|---|---|---|
| Lead implantation with transesophageal echocardiography | All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance Receives: Procedure: Transesophageal guidance of lead implantation | |
| Lead implantation without transesophageal echocardiography (retrospective) | All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
Lead induced tricuspid regurgitation measured by transthoracic echocardiography
Measured: 2 - 7 days post-implant (at hospital discharge)
Secondary outcomes (4)
Dose-are product
Dose-are product applied during lead implantation
Measured: Intraprocedural
Lead revisions
Incidence of acute lead revisions within 30 days
Measured: 30 days
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
Lead induced tricuspid regurgitation measured by transthoracic echocardiography
Measured: 3 months
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
Lead induced tricuspid regurgitation measured by transthoracic echocardiography
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 posted30 Jun 2021
- Study start1 Nov 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Tricuspid Valve InsufficiencyStudies 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
- 124 participants (actual)
- Target duration
- 12 Months
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, PD Dr. med., Principal investigator, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945005
- Sponsor's protocol ID
- 101214
- Acronym
- PLACE
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gmeiner J, Sadoni S, Orban M, Fichtner S, Estner H, Massberg S, Hagl C, Nabauer M, Hausleiter J, Braun D. Prevention of Pacemaker Lead-Induced Tricuspid Regurgitation by Transesophageal Echocardiography Guided Implantation. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2636-2638. doi: 10.1016/j.jcin.2021.08.042. No abstract available.
PubMed 34887055
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. 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 Registry
- ClinicalTrials.gov ID
- NCT04945005
- Acronym / sponsor ID
- PLACE / 101214
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- LMU KlinikumUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Jun 2021 (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.
Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.
Detailed description
Lead induced tricuspid regurgitation is a common finding after pacemaker/ICD Implantation. Transesophageal echocardiography (TEE) might be used to guide lead implantations in order to prevent tricuspid regurgitation.
In this registry, patients undergoing pacemaker/ICD implantation including a transtricuspid lead are enrolled. While in most patients lead implantation is guided by fluroscopy, in some patients lead implantation is guided by TEE in addition to fluroscopy.
Aims of this registry: Evaluation of
- Incidence of lead induced tricuspid regurgitation
- Mortality and morbidity of lead induced tricuspid regurgitation
- Identification of risk factors for lead induced tricuspid regurgitation
- Influence of the lead position within the tricuspid valve on the incidence of lead induced tricuspid regurgitation
- Prevention of lead induced tricuspid regurgitation by TEE-guided lead implantation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lead implantation with transesophageal echocardiography | – | Procedure: Transesophageal guidance of lead implantationAll patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance |
| Lead implantation without transesophageal echocardiography (retrospective) | – | –All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients undergoing pacemaker/ICD implantation including a transtricuspid lead were included in this registry.
Key inclusion criteria (1 listed)
- indication for pacemaker/ICD implantation including a transtricuspid lead according to guidelines
Key exclusion criteria (2 listed)
- pre-existing RV lead
- pre-existing TR >2
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 |
|---|---|---|
| Transesophageal guidance of lead implantationIn patients undergoing lead implantation including transesophageal echocardiography for clinical reasons (e.g. intraprocedural cardioversion), echocardiography was also used for guidance of lead implantation to reduce lead-leaflet interactions | Procedure or surgery | Lead implantation with transesophageal echocardiography |
Primary outcome
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
Time frame: 2 - 7 days post-implant (at hospital discharge)
Lead induced tricuspid regurgitation measured by transthoracic echocardiography
4 secondary outcomes
Dose-are product
Time frame: Intraprocedural
Lead revisions
Time frame: 30 days
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
Time frame: 3 months
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)
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 30 Jun 2021.
- Derived from this study: PubMed 34887055Gmeiner J, Sadoni S, Orban M, Fichtner S, Estner H, Massberg S, Hagl C, Nabauer M, Hausleiter J, Braun D. Prevention of Pacemaker Lead-Induced Tricuspid Regurgitation by Transesophageal Echocardiography Guided Implantation. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2636-2638. doi: 10.1016/j.jcin.2021.08.042. No abstract available.
- 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. This study is not recruiting at the moment.
Daniel Braun, PD Dr. med. 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?
An observational study of Tricuspid Valve Insufficiency 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 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 30 Jun 2021. 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?
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?
Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4) (time frame: 2 - 7 days post-implant (at hospital discharge)). 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 NCT04945005, 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 30 Jun 2021.