AV Block CompleteNCT06814574
Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement
An observational study of AV Block Complete and Tricuspid Regurgitation (TR), run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear. This study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing TTVR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AV Block Complete, Tricuspid Regurgitation (TR)
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 31 Jan 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will include every patient with a transcatheter tricuspid valve replacement in the study period.
Who may be able to join
- Transcatheter Tricuspid Valve Replacement
Who cannot join
- no defined exclusion criteria
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
Deutsches Herzzentrum München
München, Bavaria, 80796
About this study
Official title: Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear. This study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing TTVR.
- Conditions
- AV Block Complete, Tricuspid Regurgitation (TR)
- Medical subject headings
- Tricuspid Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
The number of patients in whom the initially chosen pacemaker implantation approach was successfully performed, relative to all pacemaker implantations following TTVI.
Measured: at the time of surgery
Feasibility
Successful pacemaker implantation, regardless of the type of pacemaker, in relation to all patients with a relevant indication following TTVR.
Measured: at the time of surgery
Safety
Peri- and postprocedural complications associated with pacemaker implantation after TTVR.
Measured: through study completion (an average of 6 Months)
Secondary outcomes (3)
Type of Pacemaker Implantation
eg. Leadless, right ventricular lead, coronary sinus lead, epicardial lead
Measured: at the time of surgery
Pacemaker Implantation - Procedural Details
Procedural Details of the pacemaker Implantation, e.g. Fluoroscopy Time, OP-Duration.
Measured: at the time of surgery
Electric Performance
Performance of the electrical pacemaker parameters (e.g. Sensing, Stimulation Threshold, Impedance). Intraoperative measurements and routine device-interrogations in follow-Up.
Measured: at the time of surgery, through study completion (an average of 6 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jan 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AV Block CompleteStudies 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
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814574
- Sponsor's protocol ID
- GER-EP-26
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement - Single Center Experience
- ClinicalTrials.gov ID
- NCT06814574
- Acronym / sponsor ID
- GER-EP-26
- Conditions
- AV Block Complete, Tricuspid Regurgitation (TR)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 7 Feb 2025 (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.
Transcatheter tricuspid valve replacement (TTVR) is associated with a high risk of third-degree atrioventricular block (AVB). However, the optimal pacemaker management following TTVR remains unclear. This study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing TTVR.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include every patient with a transcatheter tricuspid valve replacement in the study period.
Key inclusion criteria (1 listed)
- Transcatheter Tricuspid Valve Replacement
Key exclusion criteria (1 listed)
- no defined exclusion criteria
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
Success
Time frame: at the time of surgery
The number of patients in whom the initially chosen pacemaker implantation approach was successfully performed, relative to all pacemaker implantations following TTVI.
Feasibility
Time frame: at the time of surgery
Successful pacemaker implantation, regardless of the type of pacemaker, in relation to all patients with a relevant indication following TTVR.
Safety
Time frame: through study completion (an average of 6 Months)
Peri- and postprocedural complications associated with pacemaker implantation after TTVR.
3 secondary outcomes
Type of Pacemaker Implantation
Time frame: at the time of surgery
Pacemaker Implantation - Procedural Details
Time frame: at the time of surgery
Electric Performance
Time frame: at the time of surgery, through study completion (an average of 6 Months)
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 7 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
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 AV Block Complete and Tricuspid Regurgitation (TR), run by Deutsches Herzzentrum Muenchen 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 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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 Carsten Lennerz, PD Dr. med. (0049 89 1218 4401, lennerz@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: at the time of surgery). The study lists 3 primary outcomes in all. 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 7 Feb 2025.