Atrioventricular Block, Second and Third DegreeSTAYNCT06026683
Conduction System Stimulation to Avoid Left Ventricle Dysfunction
A study testing Pacemaker implant in people with Atrioventricular Block, Second and Third Degree and Pacemaker-Induced Cardiomyopathy, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy, Heart Failure
- What is being tested?
- Pacemaker implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2019to 30 Nov 2023
- 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 of 18 years or more
- Preserved or mild deteriorated LVEF (Simpson >40%) assessed by a recent (<1 month before implantation) transthoracic echocardiography.
- Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (>50%).
- Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up.
Who cannot join
- Indication for implantable cardioverter defibrillator device.
- Patients with previous LVD and a recovered LVEF
- History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization
- Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to atrioventricular conduction block (AV block).
After informed consent signature, patients with high degree AV block and normal LVEF will be randomized to permanent pacemaker stimulation with CSP vs RVAP.
All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up.
Read the detailed description
The STAY trial (Conduction System sTimulation to Avoid left ventricle dYsfunction) is a single-center, prospective, randomized, parallel, controlled study, comparing mid-term outcomes in a population undergoing pacemaker implantation due to a high degree atrio-ventricular block (AVB). The study was approved by the Hospital Ethics Committee, in accordance with the Declaration of Helsinki. All patients signed informed consent and were implanted between September 2019 until December 2022 in a 1:1 randomized fashion to conventional RVAP vs CSP (HBS or LBBS). Randomization was performed during the pre-procedural antibiotic infusion.
All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up, including demographic and clinical characteristics, physical examination, twelve-lead ECG, Minnesota score (MLWHFQ), and blood test with NT-ProBNP determination. Patients also have a transthoracic echography before the procedure and at 6 months follow-up.
At 6 months echocardiographic and clinical data will be compared.
- Conditions
- Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy, Heart Failure
- Being tested
- Pacemaker implant
- Medical subject headings
- Atrioventricular Block, Neoplasm Metastasis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantDevice
Implantation of pacemaker with conduction system pacing or right ventricular apical pacing
| Study group | Role | What they receive |
|---|---|---|
| CSP (Conduction system pacing) | Active comparator | Patients with pacemaker implanted with conduction system pacing. Receives: Device: Pacemaker implant |
| RVAP (Right ventricular apical pacing) | Active comparator | Patients with pacemaker implanted with right ventricular apical pacing. Receives: Device: Pacemaker implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta-LVEF at 6 months
Change in LVEF in each group at 6 months vs baseline LVEF
Measured: 6 months
Secondary outcomes (7)
Delta-LVEDD at 6 months
Change in Left ventricular end diastolic diameter (LVEDD) in each group at 6 months vs baseline LVEDD
Measured: 6 months
Delta-MLWHFQ (Minnesota score) at 6 months
Change in MLWHFQ score in each group at 6 months vs baseline MLWHFQ score. The MLWHFQ score is obtained by using a questionnaire of 21 aspects. It depicts how heart failure affected the daily life of the patients during the last month previous to the questionnaire. Each question can be scored from 0 ("No" effect) to 5 ("Very much" effect)
Measured: 6 months
Delta-New York Heart Association (NYHA) class at 6 months
Change in NYHA class in each group at 6 months vs baseline NYHA class. NYHA class places patients in one of four categories based on limitations of physical activity:
- I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
- II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
- III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
- IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: 6 months
Delta-NTProBNP at 6 months
Change in NTProBNP levels in each group at 6 months vs baseline NTProBNP levels
Measured: 6 months
Readmissions due to heart failure
Number of readmissions due to heart failure in each group during follow-up
Measured: 6 months
New onset Atrial fibrillation
Number of new-onset atrial fibrillation episodes in each group during follow-up
Measured: 6 months
Mortality
All-cause Mortality in each group during follow-up
Measured: 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 Sep 2023
- Study start30 Sep 2019
- Primary completion2 Oct 2023
- Study completion30 Nov 2023
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 Atrioventricular Block, Second and Third DegreeStudies 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
- Patients will be randomized into 2 groups according to pacing site: CSP vs RVAP.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ermengol Vallès, Parc de Salut Mar
- Investigators
- Ermengol Vallès, PhD, Study director, Parc de Salut MarCarlos González, M.D., Principal investigator, Parc de Salut Mar. Universitat Autónoma de Barcelona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026683
- Sponsor's protocol ID
- STAY trial
- Acronym
- STAY
- Status last verified
- Apr 2024
- First submitted
- 28 Aug 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data will only be available upon reasonable request.
Publications
Gonzalez-Matos CE, Rodriguez-Queralto O, Zaraket F, Jimenez J, Casteigt B, Valles E. Conduction System Stimulation to Avoid Left Ventricle Dysfunction. Circ Arrhythm Electrophysiol. 2024 Feb;17(2):e012473. doi: 10.1161/CIRCEP.123.012473. Epub 2024 Jan 29.
PubMed 38284238
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduction System Stimulation to Avoid Left Ventricle Dysfunction
- ClinicalTrials.gov ID
- NCT06026683
- Acronym / sponsor ID
- STAY / STAY trial
- Conditions
- Atrioventricular Block, Second and Third Degree, Pacemaker-Induced Cardiomyopathy, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 7 Sep 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.
The aim of the study is to demonstrate that conduction system pacing (CSP) can preserve a normal ventricular function compared to right ventricular apical pacing (RVAP) in patients with pre-implant preserved left ventricular ejection fraction (LVEF) and a high burden of expected ventricular pacing due to atrioventricular conduction block (AV block).
After informed consent signature, patients with high degree AV block and normal LVEF will be randomized to permanent pacemaker stimulation with CSP vs RVAP.
All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up.
Detailed description
The STAY trial (Conduction System sTimulation to Avoid left ventricle dYsfunction) is a single-center, prospective, randomized, parallel, controlled study, comparing mid-term outcomes in a population undergoing pacemaker implantation due to a high degree atrio-ventricular block (AVB). The study was approved by the Hospital Ethics Committee, in accordance with the Declaration of Helsinki. All patients signed informed consent and were implanted between September 2019 until December 2022 in a 1:1 randomized fashion to conventional RVAP vs CSP (HBS or LBBS). Randomization was performed during the pre-procedural antibiotic infusion.
All the patients have a complete evaluation before the procedure and at 3 and 6 months follow-up, including demographic and clinical characteristics, physical examination, twelve-lead ECG, Minnesota score (MLWHFQ), and blood test with NT-ProBNP determination. Patients also have a transthoracic echography before the procedure and at 6 months follow-up.
At 6 months echocardiographic and clinical data will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into 2 groups according to pacing site: CSP vs RVAP.
| Arm | Type | Receives |
|---|---|---|
| CSP (Conduction system pacing) | Active comparator | Device: Pacemaker implantPatients with pacemaker implanted with conduction system pacing. |
| RVAP (Right ventricular apical pacing) | Active comparator | Device: Pacemaker implantPatients with pacemaker implanted with right ventricular apical pacing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 years or more
- Preserved or mild deteriorated LVEF (Simpson >40%) assessed by a recent (<1 month before implantation) transthoracic echocardiography.
- Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (>50%).
- Live expectancy of more than 6 months and capability to understand the protocol, signing the informed consent form and accomplish the follow-up.
Key exclusion criteria (4 listed)
- Indication for implantable cardioverter defibrillator device.
- Patients with previous LVD and a recovered LVEF
- History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization
- Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.
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 |
|---|---|---|
| Pacemaker implantImplantation of pacemaker with conduction system pacing or right ventricular apical pacing | Device | CSP (Conduction system pacing), RVAP (Right ventricular apical pacing) |
Primary outcome
Delta-LVEF at 6 months
Time frame: 6 months
Change in LVEF in each group at 6 months vs baseline LVEF
7 secondary outcomes
Delta-LVEDD at 6 months
Time frame: 6 months
Delta-MLWHFQ (Minnesota score) at 6 months
Time frame: 6 months
Delta-New York Heart Association (NYHA) class at 6 months
Time frame: 6 months
Delta-NTProBNP at 6 months
Time frame: 6 months
Readmissions due to heart failure
Time frame: 6 months
New onset Atrial fibrillation
Time frame: 6 months
Mortality
Time frame: 6 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 3 Apr 2024.
- Derived from this study: PubMed 38284238Gonzalez-Matos CE, Rodriguez-Queralto O, Zaraket F, Jimenez J, Casteigt B, Valles E. Conduction System Stimulation to Avoid Left Ventricle Dysfunction. Circ Arrhythm Electrophysiol. 2024 Feb;17(2):e012473. doi: 10.1161/CIRCEP.123.012473. Epub 2024 Jan 29.
- Individual participant dataSharing planned: No. Data will only be available upon reasonable request.
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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.
Ermengol Vallès, PhD study director
Parc de Salut Mar
Carlos González, M.D. principal investigator
Parc de Salut Mar. Universitat Autónoma de Barcelona.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker implant in people with Atrioventricular Block, Second and Third Degree and Pacemaker-Induced Cardiomyopathy, run by Parc de Salut Mar at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 3 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 1 site in Spain. 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?
Delta-LVEF at 6 months (time frame: 6 months). 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 NCT06026683, 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 3 Apr 2024.