Cardiac PacingLEAPNCT04595487
LVSP vs RVP in Patients With AV Conduction Disorders
A study testing Left ventricular septal pacing and Right ventricular pacing in people with Cardiac Pacing and Pacing-Induced Cardiomyopathy, run by Maastricht University at 13 sites in 7 countries.
Trial summary
Rationale: Permanent cardiac pacing is the only available therapy in patients with atrioventricular (AV) conduction disorders and can be life-saving. Right ventricular pacing (RVP), the routine clinical practice for decades in these patients, is non-physiologic, leads to dyssynchronous electrical and mechanical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacing, Pacing-Induced Cardiomyopathy, Conduction System Pacing
- What is being tested?
- Left ventricular septal pacing and Right ventricular pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 1 May 2021to 1 May 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
- Age > 18y
- Life expectancy with good functional status of > 1y
- Class I or IIa pacemaker indication due to AV conduction disorder
- Acquired 3rd or 2nd degree AVB
- Atrial arrhythmia with slow ventricular conduction
- Expected ventricular pacing percentage > 20%
- LVEF >/= 40%
- Signed and dated informed consent form
Who cannot join
- HF NYHA class III-IV
- Class I indication for CRT
- Class I indication for ICD
- Previous implanted CIED (except for ILR)
- Atrial arrhythmia with planned AV junction ablation
- PCI or CABG <30 days before enrollment
Show all 11Show fewer
- Valvular heart disease with indication for valve repair or replacement
- Hypertrophic cardiomyopathy with interventricular septum thickness > 2 cm
- Renal insufficiency requiring hemodialysis
- Active infectious disease or malignancy
- Pregnancy
Trial locations and contacts
13 sites in 7 countries.
13 sites in 7 countries
Netherlands6 sites, 6 recruiting
- Recruiting
Noordwest Ziekenhuisgroep
Alkmaar
Stefan Timmer, MD, PhD
- Recruiting
Reinier de Graaf Gasthuis
Delft
Arnaud Hauer, MD, PhD
- Recruiting
Catharina Ziekenhuis
Eindhoven
Nard Rademakers, MD, PhD
- Recruiting
Medisch Spectrum Twente
Enschede
Jurren van Opstal, MD, PhD
- Recruiting
Maastricht University
Maastricht, Limburg, 6229 ER
Justin Luermans, PhD, justin.luermans@mumc.nl
- Recruiting
Sint Antonius Ziekenhuis
Nieuwegein
Vincent van Dijk, MD, PhD
Belgium2 sites, 2 recruiting
- Not yet recruiting
Ziekenhuis Oost Limburg
Genk
Wilfried Mullens, MD, PhD
- Not yet recruiting
University Hospital Gent
Ghent
Jan de Pooter, MD, PhD
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Kralovske Vinohrady
Prague
Karol Curila, MD, PhD
Italy1 site, 1 recruiting
- Not yet recruiting
Policlinico Casilino
Rome
Domenico Grieco, MD, PhD
Poland1 site, 1 recruiting
- Not yet recruiting
University Hospital Jaegellonian
Krakow
Marek Jastrzebski, MD, PhD
Spain1 site, 1 recruiting
- Not yet recruiting
Hospital Universitario y Politecnico La Fe
Valencia
Óscar Cano Pérez, MD, PhD
Switzerland1 site, 1 recruiting
- Not yet recruiting
University Hospital of Geneva
Geneva
Haran Burri, MD, PhD
About this study
Official title: Permanent Left Ventricular Septal Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Conduction Disorders: a Randomized Trial: LEAP Trial
Rationale:
Permanent cardiac pacing is the only available therapy in patients with atrioventricular (AV) conduction disorders and can be life-saving. Right ventricular pacing (RVP), the routine clinical practice for decades in these patients, is non-physiologic, leads to dyssynchronous electrical and mechanical activation of the ventricles, and may cause pacing-induced cardiomyopathy and heart failure.
Read more
Left ventricular septal pacing (LVSP) is an emerging form of physiologic pacing that can possibly overcome the adverse effects of RVP.
Study design and hypotheses:
The LEAP trial is a multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study that compares LVSP with conventional RVP. A total of four hundred seventy patients with a class I or IIa indication for pacemaker implantation due to AV conduction disorders and an expected ventricular pacing percentage >20% will be randomized 1:1 to LVSP or RVP. The primary endpoint is a composite endpoint of all-cause mortality, hospitalization for heart failure and a more than 10% decrease in left ventricular ejection fraction (LVEF) in absolute terms leading to a LVEF below 50% at one year follow-up. LVSP is anticipated to result in improved outcomes.
Secondary objectives are to evaluate whether LVSP is cost-effective and associated with an improved quality of life (QOL) as compared to RVP. Quality of life is expected to improve with LVSP and reduced healthcare resource utilizations are expected to ensure lower costs in the LVSP group during follow-up, despite initial higher costs of the implantation.
Study design: Multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study.
Study population: Adult patients with a bradycardia-pacing indication because of AV conduction disorders with an expected ventricular pacing percentage of ≥ 20% and a left ventricular ejection fraction (LVEF) >/= 40%. Four hundred seventy patients will be randomized 1:1 to LVSP or RVP.
Intervention: LVSP vs RVP.
Main study parameters/endpoints:
The primary endpoint is a composite of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to an LVEF below 50%, which as a binary combined endpoint will be determined at one year follow-up.
Secondary endpoints are:
- Time to first occurrence of all cause mortality or hospitalization for heart failure.
- Time to first occurrence of all cause mortality.
- Time to first occurrence of hospitalization for heart failure.
- Time to first occurrence of atrial fibrillation (AF) de novo.
- The echocardiographic changes in LVEF at one year.
- The echocardiographic changes in diastolic (dys-)function at one year.
- The occurrence of pacemaker related complications.
- Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact analysis (BIA).
The secondary endpoints (other than echocardiographic LVEF change) will be determined at the end of the follow-up period, when the last included patient has reached one year follow-up. The individual follow-up time for patients at this time point will vary with a minimum of one year.
- Conditions
- Cardiac Pacing, Pacing-Induced Cardiomyopathy, Conduction System Pacing, Left Ventricular Septal Pacing, Atrioventricular Block
- Being tested
- Left ventricular septal pacing, Right ventricular pacing
- Medical subject headings
- Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left ventricular septal pacingProcedure or surgery
In the LVSP group, instead of placing the standard RV lead, the commercially available 3830 Select Secure (Medtronic, Minneapolis, USA) lead is introduced via standard transvenous approach and positioned against the right ventricular side of the IVS by using the commercially available non-deflectable septal delivery sheath (C315, Medtronic, Minneapolis, USA) under fluoroscopic guidance. Subsequently this pacing lead is advanced/screwed through the interventricular septum until the left ventricular septum is reached. Accurate lead position at the left ventricular septum will be determined anatomically using fluoroscopy, and electrically by evaluating local electrograms and changes in paced electrocardiogram morphology.
In case of unsuccessful lead positioning in the left ventricular septum, the Select Secure lead may be placed at the His bundle region (natural conduction system of the heart) or in the right ventricle according to the physician's discretion.
Right ventricular pacingProcedure or surgery
In the RVP group, the ventricular pacing lead is positioned in the right ventricle.
| Study group | Role | What they receive |
|---|---|---|
| left ventricular septal pacing | Experimental | Implantation of a pacemaker with the ventricular lead delivered transvenously through the interventricular septum (IVS) to the left ventricular (LV) septum. Receives: Procedure: Left ventricular septal pacing |
| right ventricular pacing | Active comparator | Implantation of a pacemaker with the ventricular lead placed in the RV. Receives: Procedure: Right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary combined endpoint consisting of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to a LVEF below 50%.
Hospitalization for heart failure is defined as:
- hospitalization or unplanned hospital visits for heart failure requiring intravenous diuretics and/or (adjustment of) other medical heart failure therapy;
- hospitalization for upgrade to cardiac resynchronization therapy (CRT, ie biventricular pacing) for progression of heart failure with worsening NYHA class and/or (increased) need for diuretic therapy or other medical heart failure therapy;
- or hospitalization for upgrade to CRT for developing a class I indication for CRT (includes symptomatic heart failure);
- or hospitalization or unplanned hospital visit for heart failure triggered by an episode of atrial fibrillation with uncontrolled heart rate requiring intravenous diuretics or adjustment of rate control therapy.
All-cause mortality is defined as death from any cause and subdivided into cardiovascular and non-cardiovascular death.
Measured: Determined at one year follow-up
Secondary outcomes (10)
Time to first occurrence of hospitalization for heart failure.
Hospitalization for heart failure is defined as:
- hospitalization or unplanned hospital visits for heart failure requiring intravenous diuretics and/or (adjustment of) other medical heart failure therapy;
- hospitalization for upgrade to cardiac resynchronization therapy (CRT, ie biventricular pacing) for progression of heart failure with worsening NYHA class and/or (increased) need for diuretic therapy or other medical heart failure therapy;
- or hospitalization for upgrade to CRT for developing a class I indication for CRT (includes symptomatic heart failure);
- or hospitalization or unplanned hospital visit for heart failure triggered by an episode of atrial fibrillation with uncontrolled heart rate requiring intravenous diuretics or adjustment of rate control therapy.
Measured: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Time to first occurrence of all cause mortality.
All-cause mortality is defined as death from any cause and subdivided into cardiovascular and non-cardiovascular death.
Measured: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Time to first occurrence of all cause mortality or hospitalization for heart failure.
All cause mortality and hospitalization for heart failure are defined as mentioned in secondary outcome 1 and 2.
Measured: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Time to first occurrence of atrial fibrillation (AF) de novo.
Occurrence of atrial fibrillation de novo is defined as:
Occurrence of a first clinical or subclinical episode of AF as diagnosed respectively by ECG (clinical AF) or by pacemaker interrogation (subclinical AF/atrial high rate episode, lasting > 24 hours) in patients without a history of AF.
Measured: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
The echocardiographic changes in left ventricular ejection fraction (LVEF) at one year.
Change in LVEF is based on echocardiography at one year follow-up as compared to baseline echocardiography.
Measured: Determined at one year follow-up
The echocardiographic changes in diastolic (dys-)function at one year.
Diastolic function will be assessed by determining the following echocardiographic parameters at baseline and one year follow-up: E-wave, A-wave, E/A ratio, e' septal and lateral, E/e', 2D-strain of the left ventricle and atrium, pressure gradient across the tricuspid valve (dPTI) and volume of the left-atrium (LAVI). Diastolic function will be graded according to the current guidelines.
Measured: Determined at one year follow-up
The occurrence of pacemaker related complications.
Pacemaker (implantation) related complications occurring during pacemaker implantation or during follow-up after pacemaker implantation consisting of: pneumothorax; cardiac tamponade; pocket hematoma requiring re-intervention; pacemaker infection; lead luxation, dislocation, or perforation requiring re-intervention; pacemaker and lead dysfunction during follow-up (elevated threshold/sensing issues/early battery depletion) requiring re-intervention.
Measured: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Quality of Life analysis reported as Quality Adjusted Life Years (QALYs)
Quality of life will be analyzed using the EQ-5D-5L questionnaire at baseline, 6 and 12 months follow-up and every 6 months thereafter.
Measured: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Cost effectiveness analysis (CEA)
A trial based economical evaluation from a societal perspective will be performed in accordance with the Dutch guidelines for economical evaluations in healthcare.
Resource use will be measured from a societal perspective using data from case record forms and the Medical Consumption (MCQ) and Productivity loss (PCQ) questionnaires.
Measured: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Budget Impact Analysis (BIA)
Budget impact analysis will be performed from a societal, health care provider and health care insurer perspective. The eligible population will be estimated based on national health care data.
Costs of the intervention and heart failure costs will be included. Indirect costs will not be included. The time horizon will be 3 years. The expected uptake rate will be estimated based on a panel of experts (cardiologists, implementation specialist, patient representatives) and analyses will be performed for this expected uptake rate and several slightly higher and lower uptake rates. Uncertainties and scenarios will be discussed in a panel of experts as well and different scenarios will be analysed. Recommendations of the ISPOR task force are followed for all BIA calculations.
Measured: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 May 2021
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PacingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Medtronic
- Responsible party
- Sponsor
- Investigators
- Justin Luermans, MD PhD, Principal investigator, Department of CardiologyKevin Vernooy, MD PhD, Principal investigator, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595487
- Sponsor's protocol ID
- NL72047.068.20
- Acronym
- LEAP
- Status last verified
- Apr 2024
- First submitted
- 1 Oct 2020
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permanent Left Ventricular Septal Pacing Versus Right Ventricular Pacing in Patients With Atrioventricular Conduction Disorders: a Randomized Trial: LEAP Trial
- ClinicalTrials.gov ID
- NCT04595487
- Acronym / sponsor ID
- LEAP / NL72047.068.20
- Conditions
- Cardiac Pacing, Pacing-Induced Cardiomyopathy, Conduction System Pacing, Left Ventricular Septal Pacing, Atrioventricular Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Medtronic
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 20 Oct 2020 (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.
Rationale:
Permanent cardiac pacing is the only available therapy in patients with atrioventricular (AV) conduction disorders and can be life-saving. Right ventricular pacing (RVP), the routine clinical practice for decades in these patients, is non-physiologic, leads to dyssynchronous electrical and mechanical activation of the ventricles, and may cause pacing-induced cardiomyopathy and heart failure.
Left ventricular septal pacing (LVSP) is an emerging form of physiologic pacing that can possibly overcome the adverse effects of RVP.
Study design and hypotheses:
The LEAP trial is a multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study that compares LVSP with conventional RVP. A total of four hundred seventy patients with a class I or IIa indication for pacemaker implantation due to AV conduction disorders and an expected ventricular pacing percentage >20% will be randomized 1:1 to LVSP or RVP. The primary endpoint is a composite endpoint of all-cause mortality, hospitalization for heart failure and a more than 10% decrease in left ventricular ejection fraction (LVEF) in absolute terms leading to a LVEF below 50% at one year follow-up. LVSP is anticipated to result in improved outcomes.
Secondary objectives are to evaluate whether LVSP is cost-effective and associated with an improved quality of life (QOL) as compared to RVP. Quality of life is expected to improve with LVSP and reduced healthcare resource utilizations are expected to ensure lower costs in the LVSP group during follow-up, despite initial higher costs of the implantation.
Study design: Multi-center investigator-initiated, prospective, randomized controlled, open label, blinded endpoint evaluation (PROBE) study.
Study population: Adult patients with a bradycardia-pacing indication because of AV conduction disorders with an expected ventricular pacing percentage of ≥ 20% and a left ventricular ejection fraction (LVEF) >/= 40%. Four hundred seventy patients will be randomized 1:1 to LVSP or RVP.
Intervention: LVSP vs RVP.
Main study parameters/endpoints:
The primary endpoint is a composite of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to an LVEF below 50%, which as a binary combined endpoint will be determined at one year follow-up.
Secondary endpoints are:
- Time to first occurrence of all cause mortality or hospitalization for heart failure.
- Time to first occurrence of all cause mortality.
- Time to first occurrence of hospitalization for heart failure.
- Time to first occurrence of atrial fibrillation (AF) de novo.
- The echocardiographic changes in LVEF at one year.
- The echocardiographic changes in diastolic (dys-)function at one year.
- The occurrence of pacemaker related complications.
- Quality of life (QOL), cost-effectiveness analyses (CEA) and budget impact analysis (BIA).
The secondary endpoints (other than echocardiographic LVEF change) will be determined at the end of the follow-up period, when the last included patient has reached one year follow-up. The individual follow-up time for patients at this time point will vary with a minimum of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| left ventricular septal pacing | Experimental | Procedure: Left ventricular septal pacingImplantation of a pacemaker with the ventricular lead delivered transvenously through the interventricular septum (IVS) to the left ventricular (LV) septum. |
| right ventricular pacing | Active comparator | Procedure: Right ventricular pacingImplantation of a pacemaker with the ventricular lead placed in the RV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18y
- Life expectancy with good functional status of > 1y
- Class I or IIa pacemaker indication due to AV conduction disorder
- Expected ventricular pacing percentage > 20%
- LVEF >/= 40%
Key exclusion criteria (11 listed)
- HF NYHA class III-IV
- Class I indication for CRT
- Class I indication for ICD
- Previous implanted CIED (except for ILR)
- Atrial arrhythmia with planned AV junction ablation
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 ventricular septal pacingIn the LVSP group, instead of placing the standard RV lead, the commercially available 3830 Select Secure (Medtronic, Minneapolis, USA) lead is introduced via standard transvenous approach and positioned against the right ventricular side of the IVS by using the commercially available non-deflectable septal delivery sheath (C315, Medtronic, Minneapolis, USA) under fluoroscopic guidance. Subsequently this pacing lead is advanced/screwed through the interventricular septum until the left ventricular septum is reached. Accurate lead position at the left ventricular septum will be determined anatomically using fluoroscopy, and electrically by evaluating local electrograms and changes in paced electrocardiogram morphology. In case of unsuccessful lead positioning in the left ventricular septum, the Select Secure lead may be placed at the His bundle region (natural conduction system of the heart) or in the right ventricle according to the physician's discretion. | Procedure or surgery | left ventricular septal pacing |
| Right ventricular pacingIn the RVP group, the ventricular pacing lead is positioned in the right ventricle. | Procedure or surgery | right ventricular pacing |
Primary outcome
Binary combined endpoint consisting of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to a LVEF below 50%.
Time frame: Determined at one year follow-up
Hospitalization for heart failure is defined as: 1. hospitalization or unplanned hospital visits for heart failure requiring intravenous diuretics and/or (adjustment of) other medical heart failure therapy; 2. hospitalization for upgrade to cardiac resynchronization therapy (CRT, ie biventricular pacing) for progression of heart failure with worsening NYHA class and/or (increased) need for diuretic therapy or other medical heart failure therapy; 3. or hospitalization for upgrade to CRT for developing a class I indication for CRT (includes symptomatic heart failure); 4. or hospitalization or unplanned hospital visit for heart failure triggered by an episode of atrial fibrillation with uncontrolled heart rate requiring intravenous diuretics or adjustment of rate control therapy. All-cause mortality is defined as death from any cause and subdivided into cardiovascular and non-cardiovascular death.
10 secondary outcomes
Time to first occurrence of hospitalization for heart failure.
Time frame: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Time to first occurrence of all cause mortality.
Time frame: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Time to first occurrence of all cause mortality or hospitalization for heart failure.
Time frame: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Time to first occurrence of atrial fibrillation (AF) de novo.
Time frame: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
The echocardiographic changes in left ventricular ejection fraction (LVEF) at one year.
Time frame: Determined at one year follow-up
The echocardiographic changes in diastolic (dys-)function at one year.
Time frame: Determined at one year follow-up
The occurrence of pacemaker related complications.
Time frame: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Quality of Life analysis reported as Quality Adjusted Life Years (QALYs)
Time frame: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Cost effectiveness analysis (CEA)
Time frame: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Budget Impact Analysis (BIA)
Time frame: Determined at the end of the follow-up period (when the last-included patient reached the one year follow-up period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- 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.
Justin Luermans, MD PhD principal investigator
Department of Cardiology
Kevin Vernooy, MD PhD principal investigator
Department of Cardiology
13 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left ventricular septal pacing and Right ventricular pacing in people with Cardiac Pacing and Pacing-Induced Cardiomyopathy, run by Maastricht University at 13 sites in 7 countries.
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 8 inclusion and 11 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Belgium, Czechia, Italy, Poland and 2 more countries. 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?
Contact Justin Luermans, MD PhD (+31433875093, justin.luermans@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary combined endpoint consisting of all-cause mortality, hospitalization for heart failure, and a more than 10% point decrease in left ventricular ejection fraction (LVEF) leading to a LVEF below 50%. (time frame: Determined at one year follow-up). 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 15 Apr 2024.