Aortic Valve StenosisNCT05895097
Conventional Versus Left Bundle Branch Pacing in TAVI
A study testing Left bundle branch pacemaker and Conventional pacing in people with Aortic Valve Stenosis and Heart Failure, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (< 50 %) that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy
- What is being tested?
- Left bundle branch pacemaker and Conventional pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Jun 2023to 15 Jun 2026
- 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
- Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)
- Left ventricular ejection fraction < 50 %.
Who cannot join
- Unsuccessful TAVI procedure with life expectancy < 1 year
- Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)
- Severe kidney failure (glomerular filtration rate < 30 ml/min)
- Previous permanent pacemaker
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Medical Centre Ljubljana
Ljubljana, 1000
Klemen Steblovnik, MD, PhD, 0038615228529, steblovnik@gmail.com
Klemen Steblovnik, MD, PhD
About this study
Official title: Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).
Read the detailed description
Bradycardic heart rhythm disturbances are a common complication of TAVI. Patients who will develop the indication for permanent pacemaker implantation after TAVI will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) group. The investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. The investigators will also compare electrocardiographic (QRS duration), clinical (NYHA status, 6-minute walking test, handgrip test, Kansas City Cardiomyopathy Questionnaire) and laboratory (proBNP) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.
- Conditions
- Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy, Transcatheter Aortic Valve Implantation
- Being tested
- Left bundle branch pacemaker, Conventional pacing
- Keywords
- Transcatheter Aortic Valve Implantation, Left bundle branch pacing
- Medical subject headings
- Aortic Valve Stenosis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left bundle branch pacemakerDevice
Left bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory.
Conventional pacingDevice
Right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %
| Study group | Role | What they receive |
|---|---|---|
| Conventional pacing | Active comparator | Not described Receives: Device: Conventional pacing |
| LBB pacing | Experimental | Not described Receives: Device: Left bundle branch pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Measured: 12 months
Secondary outcomes (14)
Left ventricular systolic diameter
Measured: 12 months
Left ventricular diastolic diameter
Measured: 12 months
Global work index
Amount of myocardial work performed by the left ventricle during systole.
Measured: 12 months
Global constructive work
Positive work performed in systole + negative work performed in isovolumetric relaxation
Measured: 12 months
Global wasted work
Negative work performed in systole + positive work performed in isovolumetric relaxation
Measured: 12 months
Global work efficiency
Percentage of constructive work over total work = Constructive work/(constructive work + wasted work)
Measured: 12 months
Signs of mechanical dyssynchrony
Presence of at least one of the echocardiographic signs of mechanical dyssynchrony, such as apical rocking and septal flash.
Measured: 12 months
Systolic pulmonary artery pressure (echocardiographic parameter)
Measured: 12 months
NT-proBNP concentration
Measured: 6 and 12 months
NYHA status
Measured: 6 and 12 months
6-minute walking test
Measured: 6 and 12 months
Hand grip test
Measured: 6 and 12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: 6 and 12 months
QRS duration
Measured: baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2026 (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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klemen Steblovnik, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895097
- Sponsor's protocol ID
- PACE TAVI
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT05895097
- Acronym / sponsor ID
- PACE TAVI
- Conditions
- Aortic Valve Stenosis, Heart Failure, Pacemaker-Induced Cardiomyopathy, Transcatheter Aortic Valve Implantation
- Keywords
- Transcatheter Aortic Valve Implantation, Left bundle branch pacing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 8 Jun 2023 (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 randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).
Detailed description
Bradycardic heart rhythm disturbances are a common complication of TAVI. Patients who will develop the indication for permanent pacemaker implantation after TAVI will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) group. The investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. The investigators will also compare electrocardiographic (QRS duration), clinical (NYHA status, 6-minute walking test, handgrip test, Kansas City Cardiomyopathy Questionnaire) and laboratory (proBNP) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional pacing | Active comparator | Device: Conventional pacing |
| LBB pacing | Experimental | Device: Left bundle branch pacemaker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)
- Left ventricular ejection fraction < 50 %.
Key exclusion criteria (4 listed)
- Unsuccessful TAVI procedure with life expectancy < 1 year
- Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)
- Severe kidney failure (glomerular filtration rate < 30 ml/min)
- Previous permanent pacemaker
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 pacemakerLeft bundle branch pacing (LBBP) will be the pacing technique. In brief, after localizing the His bundle area the LBBP lead will be positioned approximately 1-1.5 cm distal to the His bundle position in the right ventricular septum. Before screwing the lead deep into the interventricular septum, the suitable position will be confirmed by fluoroscopic signs and adequate paced QSR morphology. Final lead position will be confirmed according to ECG parameters. Given that the pacing parameters with LBBP are typically low and stable, backup RV lead will not be mandatory. | Device | LBB pacing |
| Conventional pacingRight ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 % | Device | Conventional pacing |
Primary outcome
Left ventricular ejection fraction
Time frame: 12 months
14 secondary outcomes
Left ventricular systolic diameter
Time frame: 12 months
Left ventricular diastolic diameter
Time frame: 12 months
Global work index
Time frame: 12 months
Global constructive work
Time frame: 12 months
Global wasted work
Time frame: 12 months
Global work efficiency
Time frame: 12 months
Signs of mechanical dyssynchrony
Time frame: 12 months
Systolic pulmonary artery pressure (echocardiographic parameter)
Time frame: 12 months
NT-proBNP concentration
Time frame: 6 and 12 months
NYHA status
Time frame: 6 and 12 months
6-minute walking test
Time frame: 6 and 12 months
Hand grip test
Time frame: 6 and 12 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
Time frame: 6 and 12 months
QRS duration
Time frame: baseline, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Aortic Valve Stenosis
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruitingPhase 4
Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)
Aortic Stenosis, Severe Aortic Stenosis
Not yet recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
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 pacemaker and Conventional pacing in people with Aortic Valve Stenosis and Heart Failure, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 inclusion and 4 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 8 Jun 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 Slovenia. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (time frame: 12 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 8 Jun 2023.