Aortic Valve StenosisPLANETNCT05024279
Left Bundle Branch Area Pacing in Patients After TAVR
A study testing Left bundle branch area pacing and Right ventricular pacing in people with Aortic Valve Stenosis and AV Block, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, AV Block, Pacing-Induced Cardiomyopathy
- What is being tested?
- Left bundle branch area pacing and Right ventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 6 Aug 2021to Apr 2025
- Phase
- Interventional
- 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
Who may be able to join
- Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis
- LVEF ≥50%
- Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden >20%
- Signed informeed conseent to study participation
Who cannot join
- LVEF <50%
- Expected pacing burden <20%
- Pre-existing implanted cardiac device
- Participation in a concurring interventional trial
- age <18 years
- Current preegnancy
- life expectancy <6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pacing of the Left Bundle Branch Area NEcessitated After TAVR
Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.
Read the detailed description
Transcatheter aortic valve replacement (TAVR) is a well-established treatment of aortic valve stenosis. Yet, requiry of permanent pacing due to new onset atrio-ventricular conduction block remains a frequent complication. Standard right ventricular pacing (RVP) at high pacing burden may lead to deterioration of left ventricular function. Left-Bundle-Area Pacing (LBBP) is a new, innovative method of physiological ventricular stimulation resulting in narrow, physiological QRS complexes.
In this prospective, randomized, single center clinica trial, patients are included after TAVR and with normal left ventricular function who require pacing due to a higher degree atriao-ventricular block with an anticipated high pacing burden. Patients will be randomized to receive either left bundle branch area pacing (intervention) or right ventricular apical pacing (control).
The results will confirm the feasibility of LBBP in patients following TAVR. Results will further investigate the primary outcome of a clinically relevant QRS narrowing and a combination of exploratory secondary endpoints including clinical outcomes, functional status, laboratory biomarkers, and quality of life.
- Being tested
- Left bundle branch area pacing, Right ventricular pacing
- Keywords
- left bundle branch area pacing, av block, right ventricular pacing, aortic valve stenosis, TAVR, ECG
- Medical subject headings
- Aortic Valve Stenosis, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch area pacingDevice
Left bundle branch area pacing will be applied as established in the literature using commercially available equipment.
In case of unsuccessful application of left bundle branch area pacing, cross-over to right ventricular pacing is allowed.
Right ventricular pacingDevice
Right ventricular pacing as the standard, established form of pacing will be applied in the control group. No cross-over to the intervention arm is anticipated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Patients are randomized to receive left bundle branch are pacing due to higher degree AV block Receives: Device: Left bundle branch area pacing |
| Control Arm | Active comparator | Patients are randomized to receive standard right ventricular pacing due to higher degree AV block. Receives: Device: Right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
QRS duration
QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads
Measured: 3 months
Secondary outcomes (38)
QRS duration
QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads
Measured: 12 months
QRS duration
QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads
Measured: 24 months
Death of any cause
Measured: 3 months
Death of any cause
Measured: 12 months
Death of any cause
Measured: 24 months
Death of cardio-vascular cause
Measured: 3 months
Death of cardio-vascular cause
Measured: 12 months
Death of cardio-vascular cause
Measured: 24 months
Re-hospitalization due to heart failure
Measured: 3 months
Re-hospitalization due to heart failure
Measured: 12 months
Re-hospitalization due to heart failure
Measured: 24 months
Change in left ventricular ejection fraction
Measured: 3 months
Change in left ventricular ejection fraction
Measured: 12 months
Change in left ventricular ejection fraction
Measured: 24 months
Change in echocardiographic left ventricular enddiastolic diameter
Measured: 3 months
Change in echocardiographic left ventricular enddiastolic diameter
Measured: 12 months
Change in echocardiographic left ventricular enddiastolic diameter
Measured: 24 months
Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
Measured: 3 months
Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
Measured: 12 months
Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
Measured: 24 months
Echocardiographic assessment of right ventricular ejection fraction
Measured: 3 months
Echocardiographic assessment of right ventricular ejection fraction
Measured: 12 months
Echocardiographic assessment of right ventricular ejection fraction
Measured: 24 months
Change in New York heart failure classification status
Measured: 3 months
Change in New York heart failure classification status
Measured: 12 months
Change in New York heart failure classification status
Measured: 24 months
Change in laboratory biomarkers NT-proBNP
Measured: 3 months
Change in laboratory biomarkers NT-proBNP
Measured: 12 months
Change in laboratory biomarkers NT-proBNP
Measured: 24 months
Change in functional status by 6 minute walk
Measured: 3 months
Change in functional status by 6 minute walk
Measured: 12 months
Change in functional status by 6 minute walk
Measured: 24 months
Change in EQ-5D quality of life
Measured: 3 months
Change in EQ-5D quality of life
Measured: 12 months
Change in EQ-5D quality of life
Measured: 24 months
Occurence of arrhythmias
Measured: 3 months
Occurence of arrhythmias
Measured: 12 months
Occurence of arrhythmias
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start6 Aug 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moritz F. Sinner, Ludwig-Maximilians - University of Munich
- Investigators
- Moritz F Sinner, MD, MPH, Principal investigator, LMU Klinikum, Dept. of CardiologyStephanie Fichtner, MD, Principal investigator, LMU Klinikum, Dept. of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024279
- Sponsor's protocol ID
- 21-0575
- Acronym
- PLANET
- Status last verified
- Jan 2023
- First submitted
- 9 Aug 2021
- Last updated
- 31 Jan 2023
- 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 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pacing of the Left Bundle Branch Area NEcessitated After TAVR
- ClinicalTrials.gov ID
- NCT05024279
- Acronym / sponsor ID
- PLANET / 21-0575
- Keywords
- left bundle branch area pacing, av block, right ventricular pacing, aortic valve stenosis, TAVR, ECG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 Aug 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.
Prospective, randomized, single center clinical trial to compare the outcome of left bundle branch area pacing versus right ventricular apical pacing in patients with higher degree atrio-ventricular block and a normal left ventricular function after transcatheter aortic valve replacement.
Detailed description
Transcatheter aortic valve replacement (TAVR) is a well-established treatment of aortic valve stenosis. Yet, requiry of permanent pacing due to new onset atrio-ventricular conduction block remains a frequent complication. Standard right ventricular pacing (RVP) at high pacing burden may lead to deterioration of left ventricular function. Left-Bundle-Area Pacing (LBBP) is a new, innovative method of physiological ventricular stimulation resulting in narrow, physiological QRS complexes.
In this prospective, randomized, single center clinica trial, patients are included after TAVR and with normal left ventricular function who require pacing due to a higher degree atriao-ventricular block with an anticipated high pacing burden. Patients will be randomized to receive either left bundle branch area pacing (intervention) or right ventricular apical pacing (control).
The results will confirm the feasibility of LBBP in patients following TAVR. Results will further investigate the primary outcome of a clinically relevant QRS narrowing and a combination of exploratory secondary endpoints including clinical outcomes, functional status, laboratory biomarkers, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Left bundle branch area pacingPatients are randomized to receive left bundle branch are pacing due to higher degree AV block |
| Control Arm | Active comparator | Device: Right ventricular pacingPatients are randomized to receive standard right ventricular pacing due to higher degree AV block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Successful TAVR implantation for classical (high flow high gradient), symptomatic aortic valve stenosis
- LVEF ≥50%
- Guideline-based indication for pacing due to AV block III°, AV block II°, or symptomatic bradycardic atrial fibrillation with an expecteed ventricular pacing burden >20%
- Signed informeed conseent to study participation
Key exclusion criteria (7 listed)
- LVEF <50%
- Expected pacing burden <20%
- Pre-existing implanted cardiac device
- Participation in a concurring interventional trial
- age <18 years
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 |
|---|---|---|
| Left bundle branch area pacingLeft bundle branch area pacing will be applied as established in the literature using commercially available equipment. In case of unsuccessful application of left bundle branch area pacing, cross-over to right ventricular pacing is allowed. | Device | Intervention Arm |
| Right ventricular pacingRight ventricular pacing as the standard, established form of pacing will be applied in the control group. No cross-over to the intervention arm is anticipated. | Device | Control Arm |
Primary outcome
QRS duration
Time frame: 3 months
QRS duration on 12-lead ECG, defined as earliest Q to latest S across all leads
38 secondary outcomes
QRS duration
Time frame: 12 months
QRS duration
Time frame: 24 months
Death of any cause
Time frame: 3 months
Death of any cause
Time frame: 12 months
Death of any cause
Time frame: 24 months
Death of cardio-vascular cause
Time frame: 3 months
Death of cardio-vascular cause
Time frame: 12 months
Death of cardio-vascular cause
Time frame: 24 months
Re-hospitalization due to heart failure
Time frame: 3 months
Re-hospitalization due to heart failure
Time frame: 12 months
Re-hospitalization due to heart failure
Time frame: 24 months
Change in left ventricular ejection fraction
Time frame: 3 months
Change in left ventricular ejection fraction
Time frame: 12 months
Change in left ventricular ejection fraction
Time frame: 24 months
Change in echocardiographic left ventricular enddiastolic diameter
Time frame: 3 months
Change in echocardiographic left ventricular enddiastolic diameter
Time frame: 12 months
Change in echocardiographic left ventricular enddiastolic diameter
Time frame: 24 months
Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
Time frame: 3 months
Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
Time frame: 12 months
Echocardiographic assessment of degreee of atrio-ventricular valve insufficiency
Time frame: 24 months
Echocardiographic assessment of right ventricular ejection fraction
Time frame: 3 months
Echocardiographic assessment of right ventricular ejection fraction
Time frame: 12 months
Echocardiographic assessment of right ventricular ejection fraction
Time frame: 24 months
Change in New York heart failure classification status
Time frame: 3 months
Change in New York heart failure classification status
Time frame: 12 months
Change in New York heart failure classification status
Time frame: 24 months
Change in laboratory biomarkers NT-proBNP
Time frame: 3 months
Change in laboratory biomarkers NT-proBNP
Time frame: 12 months
Change in laboratory biomarkers NT-proBNP
Time frame: 24 months
Change in functional status by 6 minute walk
Time frame: 3 months
Change in functional status by 6 minute walk
Time frame: 12 months
Change in functional status by 6 minute walk
Time frame: 24 months
Change in EQ-5D quality of life
Time frame: 3 months
Change in EQ-5D quality of life
Time frame: 12 months
Change in EQ-5D quality of life
Time frame: 24 months
Occurence of arrhythmias
Time frame: 3 months
Occurence of arrhythmias
Time frame: 12 months
Occurence of arrhythmias
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- 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.
Moritz F Sinner, MD, MPH principal investigator
LMU Klinikum, Dept. of Cardiology
Stephanie Fichtner, MD principal investigator
LMU Klinikum, Dept. of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left bundle branch area pacing and Right ventricular pacing in people with Aortic Valve Stenosis and AV Block, run by Ludwig-Maximilians - University of Munich 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Jan 2023. 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?
Results are not available in the source record.
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?
QRS duration (time frame: 3 months). 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 31 Jan 2023.