Complete Heart BlockDEEPNCT06474819
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
A study testing Pacemaker implant in people with Complete Heart Block and Second Degree Atrioventricular Block Möbitz Type II, run by Institut d'Investigació Biomèdica de Bellvitge at 6 sites in Spain.
Trial summary
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction >50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages. Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complete Heart Block, Second Degree Atrioventricular Block Möbitz Type II
- 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
- 326 participants
- Where
- 6 sitesSpain
- Study dates
- 12 Jul 2024to 12 Jan 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (<45lpm).
- LVEF>50% at echocardiography performed maximum 7 days before pacemaker implant.
- Informed consent signature.
Who cannot join
- Life expectancy <12 months
- Severe cardiac valvular abnormality requiring intervention
- Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.
- Inclusion in another trial which may influence the results of this study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Not yet recruiting
Hospital Vall d'Hebrón
Barcelona
Raquel Adeliño Recasens
- Not yet recruiting
Hospital General Universitario de Castellón
Castellon
Clara Gunturiz Beltrán
- Not yet recruiting
Hospital Virgen de las Nieves
Granada
Manuel Molina Lerma
- Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat
Andrea Di Marco, adimarco@bellvitgehospital.cat
- Not yet recruiting
Hospital La Fe
Valencia
Oscar Cano Perez
- Not yet recruiting
Hospital Lozano Blesa
Zaragoza
Javier Ramos Maqueda
About this study
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction >50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.
Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.
- Being tested
- Pacemaker implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantDevice
All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead.
| Study group | Role | What they receive |
|---|---|---|
| deep | Experimental | The ventricular lead will be penetrated into the basal interventricular septum aiming at left septal pacing and, if not possible, at least deep septal pacing with a paced QRS duration <=140ms. Receives: Device: Pacemaker implant |
| Apex | Active comparator | The ventricular lead will be placed in the right ventricular apex. Receives: Device: Pacemaker implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pacing-induced cardiomyopathy
Decrease in the left ventricular ejection fraction (LVEF) by >10% as compared to the LVEF before pacemaker implant and final LVEF<45%.
Measured: 12 months
Secondary outcomes (5)
LVEF during follow-up
To compare the mean or median (depending on distribution) LVEF before and one year after pacemaker implant in the two groups.
Measured: 12 months
Mitral and tricuspid regurgitation
To compare the degree of mitral and tricuspid regurgitation before and one year after pacemaker implant in the two groups.
Measured: 12 months
New York Heart Association (NYHA) class
To compare the NYHA class one year after pacemaker implant in the two groups.
Measured: 12 months
Brain Natriuretic Peptide levels
To compare the N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels one year after pacemaker implant in the two groups.
Measured: 12 months
heart failure
Comparison of heart failure (HF) events in the first year after pacemaker implant in the two groups. HF events will be: hospitalizations for heart failure, emergency department or day-hospital visits for heart failure, heart failure symptoms requiring the initiation of diuretic therapy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start12 Jul 2024
- Primary completion12 Jan 2027 (estimated)
- Study completion12 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Heart BlockStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 326 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3, Hospital Universitari de Bellvitge
- Responsible party
- Principal investigator, Andrea Di Marco, Institut d'Investigació Biomèdica de Bellvitge
- Investigators
- Andrea Di Marco, MD, PhD, Principal investigator, IDIBELL and Hospital Universitario de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474819
- Sponsor's protocol ID
- DEEP
- Acronym
- DEEP
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study protocol and the informed consent form will be available upon request during the whole duration of the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06474819
- Acronym / sponsor ID
- DEEP / DEEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 326 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de BellvitgeUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3, Hospital Universitari de Bellvitge
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 12 Jan 2027 (estimated)
- Study completion
- 12 Jan 2027 (estimated)
- First posted
- 26 Jun 2024 (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.
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction >50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages.
Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep | Experimental | Device: Pacemaker implantThe ventricular lead will be penetrated into the basal interventricular septum aiming at left septal pacing and, if not possible, at least deep septal pacing with a paced QRS duration <=140ms. |
| Apex | Active comparator | Device: Pacemaker implantThe ventricular lead will be placed in the right ventricular apex. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (<45lpm).
- LVEF>50% at echocardiography performed maximum 7 days before pacemaker implant.
- Informed consent signature.
Key exclusion criteria (4 listed)
- Life expectancy <12 months
- Severe cardiac valvular abnormality requiring intervention
- Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.
- Inclusion in another trial which may influence the results of this study.
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 implantAll patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead. | Device | Apex, deep |
Primary outcome
Pacing-induced cardiomyopathy
Time frame: 12 months
Decrease in the left ventricular ejection fraction (LVEF) by >10% as compared to the LVEF before pacemaker implant and final LVEF<45%.
5 secondary outcomes
LVEF during follow-up
Time frame: 12 months
Mitral and tricuspid regurgitation
Time frame: 12 months
New York Heart Association (NYHA) class
Time frame: 12 months
Brain Natriuretic Peptide levels
Time frame: 12 months
heart failure
Time frame: 12 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 15 Jul 2024.
- Individual participant dataSharing planned: Yes. The study protocol and the informed consent form will be available upon request during the whole duration of the study.
Related trials for Complete Heart Block
Active, not recruiting
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Chronic Total Occlusion of Coronary Artery
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Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Atrial Fibrillation (AF), Atrial Flutter
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Belgo-Luxembourg Leadless PM Registry
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Recruiting
Clinical Efficacy and Safety of Left Bundle Branch Area Pacing Using Quantitative Guidance of Multimodal Data in the Treatment of Heart Failure
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RecruitingObservational study
Prospective Validation of a Pre-Specified Algorithm for the Management of Conduction Disturbances Following TAVR
Conduction Disturbances, Transcatheter Aortic Valve Replacement
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.
Andrea Di Marco, MD, PhD principal investigator
IDIBELL and Hospital Universitario de Bellvitge
6 sites 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 Complete Heart Block and Second Degree Atrioventricular Block Möbitz Type II, run by Institut d'Investigació Biomèdica de Bellvitge at 6 sites 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 3 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: looking for participants now, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
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 Andrea Di Marco, MD, PhD (+34932 60 75 00 ext. 8385, adimarco@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pacing-induced cardiomyopathy (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 15 Jul 2024.