Atrioventricular BlockPRESERVE-CSPNCT07831655
Conduction System Pacing to Prevent Pacing-Induced Cardiomyopathy
A study testing Conduction System Pacing and Right Ventricular Apical Pacing in people with Atrioventricular Block and Pacing-Induced Cardiomyopathy, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The purpose of this randomized, open-label trial was to determine whether permanent conduction system pacing preserves left ventricular function and reduces the incidence of pacing-induced cardiomyopathy compared with conventional right ventricular apical pacing in patients with preserved LVEF who required permanent… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrioventricular Block, Pacing-Induced Cardiomyopathy, Cardiac Pacing, Artificial
- What is being tested?
- Conduction System Pacing and Right Ventricular Apical Pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteSpain
- Study dates
- 17 Nov 2020to 19 Feb 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular ejection fraction greater than 50% by the Simpson four-chamber method before pacemaker implantation.
- Indication for permanent pacemaker implantation due to atrioventricular block.
- Anticipated ventricular pacing burden greater than 85%.
- At least one of the following high-risk features: structural heart disease or native QRS duration greater than 120 ms.
- Structural heart disease was defined as previously diagnosed ischemic heart disease, with or without prior myocardial infarction, and/or at least moderate left-sided valvular stenosis or regurgitation, and/or an aortic or mitral valve prosthesis.
- Provision of written informed consent.
Who cannot join
- Failure to meet all inclusion criteria.
- Refusal or inability to provide written informed consent.
- Dementia or significant cognitive impairment.
- Underlying systemic disease associated with a life expectancy of less than 1 year.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Germans Trias i Pujol, Department of Cardiology
Badalona, Barcelona, 08916
About this study
Official title: Conduction System Pacing to Preserve Left Ventricular Function in Patients Requiring Permanent Ventricular Pacing: The PRESERVE-CSP Randomized Trial
The purpose of this randomized, open-label trial was to determine whether permanent conduction system pacing preserves left ventricular function and reduces the incidence of pacing-induced cardiomyopathy compared with conventional right ventricular apical pacing in patients with preserved LVEF who required permanent ventricular pacing for atrioventricular block and were considered at increased risk because of structural heart disease and/or a wide native QRS complex.
Read the detailed description
Eligible participants had an LVEF above 50%, an indication for permanent pacemaker implantation due to atrioventricular block, an anticipated ventricular pacing burden above 85%, and either underlying structural heart disease or a native QRS duration above 120 ms. After written informed consent, participants were randomized to conduction system pacing or right ventricular apical pacing. Clinical, electrocardiographic, echocardiographic, functional, quality-of-life, and biomarker assessments were performed at baseline and at 6 months as specified in the protocol. Subsequent routine pacemaker-clinic follow-up was used to ascertain clinical events.
- Being tested
- Conduction System Pacing, Right Ventricular Apical 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.
Conduction System PacingProcedure or surgery
The ventricular lead was implanted at the His bundle or at the left bundle branch region.
Right Ventricular Apical PacingProcedure or surgery
The ventricular pacing lead was implanted in the right ventricular apical region using conventional technique.
| Study group | Role | What they receive |
|---|---|---|
| Conduction System Pacing | Experimental | Not described Receives: Procedure: Conduction System Pacing |
| Right Ventricular Apical Pacing | Active comparator | Not described Receives: Procedure: Right Ventricular Apical Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction at 6 months
Left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography using the Simpson method and expressed as a percentage, compared between the conduction system pacing and right ventricular apical pacing groups.
Measured: 6 months after pacemaker implantation
Pacing-induced cardiomyopathy at 6 months
Pacing-induced cardiomyopathy was defined as an absolute decrease in LVEF of more than 10 percentage points from baseline resulting in an LVEF below 50%, in the absence of an alternative cause, compared between study groups.
Measured: 6 months after pacemaker implantation
Secondary outcomes (8)
Absolute change in left ventricular ejection fraction, in percentage points
is the direct arithmetic difference between two percentage measurements of blood pumped out of the heart's main chamber.
Measured: Baseline to 6 months
Minnesota Living with Heart Failure Questionnaire score
ranges from 0 to 105, where a lower score indicates a better quality of life and a higher score represents a worse quality of life
Measured: 6 months
Six-minute walk distance (meters)
the total length a person can walk on a flat, hard surface during a period of six minutes
Measured: 6 months
NT-proBNP concentration
N-terminal pro-B-type natriuretic peptide concentration in pg/mL
Measured: Baseline and 6 months
Heart failure hospitalization
Any hospitalization due to heart failure decompensation
Measured: Through study follow-up (6 months)
All-cause and cardiac mortality
Mortality
Measured: Through study follow-up (6 months)
Failure of conduction system pacing (Safety)
Any problems with system pacing conduction
Measured: Through study follow-up (6 months)
Failure due to ventricular lead dislodgement or an increase in pacing threshold above 2.5 V at 1 ms.
The protocol specified study interruption if this rate exceeded 10%.
Measured: Through study follow-up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start17 Nov 2020
- Primary completion17 Jun 2024
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrioventricular 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
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831655
- Sponsor's protocol ID
- PI-19-197
- Acronym
- PRESERVE-CSP
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with third parties, in accordance with the study's data protection and privacy policies and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conduction System Pacing to Preserve Left Ventricular Function in Patients Requiring Permanent Ventricular Pacing: The PRESERVE-CSP Randomized Trial
- ClinicalTrials.gov ID
- NCT07831655
- Acronym / sponsor ID
- PRESERVE-CSP / PI-19-197
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 21 Sep 2026 (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 purpose of this randomized, open-label trial was to determine whether permanent conduction system pacing preserves left ventricular function and reduces the incidence of pacing-induced cardiomyopathy compared with conventional right ventricular apical pacing in patients with preserved LVEF who required permanent ventricular pacing for atrioventricular block and were considered at increased risk because of structural heart disease and/or a wide native QRS complex.
Detailed description
Eligible participants had an LVEF above 50%, an indication for permanent pacemaker implantation due to atrioventricular block, an anticipated ventricular pacing burden above 85%, and either underlying structural heart disease or a native QRS duration above 120 ms. After written informed consent, participants were randomized to conduction system pacing or right ventricular apical pacing. Clinical, electrocardiographic, echocardiographic, functional, quality-of-life, and biomarker assessments were performed at baseline and at 6 months as specified in the protocol. Subsequent routine pacemaker-clinic follow-up was used to ascertain clinical events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conduction System Pacing | Experimental | Procedure: Conduction System Pacing |
| Right Ventricular Apical Pacing | Active comparator | Procedure: Right Ventricular Apical Pacing |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Left ventricular ejection fraction greater than 50% by the Simpson four-chamber method before pacemaker implantation.
- Indication for permanent pacemaker implantation due to atrioventricular block.
- Anticipated ventricular pacing burden greater than 85%.
- At least one of the following high-risk features: structural heart disease or native QRS duration greater than 120 ms.
- Structural heart disease was defined as previously diagnosed ischemic heart disease, with or without prior myocardial infarction, and/or at least moderate left-sided valvular stenosis or regurgitation, and/or an aortic or mitral valve prosthesis.
Key exclusion criteria (4 listed)
- Failure to meet all inclusion criteria.
- Refusal or inability to provide written informed consent.
- Dementia or significant cognitive impairment.
- Underlying systemic disease associated with a life expectancy of less than 1 year.
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 |
|---|---|---|
| Conduction System PacingThe ventricular lead was implanted at the His bundle or at the left bundle branch region. | Procedure or surgery | Conduction System Pacing |
| Right Ventricular Apical PacingThe ventricular pacing lead was implanted in the right ventricular apical region using conventional technique. | Procedure or surgery | Right Ventricular Apical Pacing |
Primary outcome
Left ventricular ejection fraction at 6 months
Time frame: 6 months after pacemaker implantation
Left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography using the Simpson method and expressed as a percentage, compared between the conduction system pacing and right ventricular apical pacing groups.
Pacing-induced cardiomyopathy at 6 months
Time frame: 6 months after pacemaker implantation
Pacing-induced cardiomyopathy was defined as an absolute decrease in LVEF of more than 10 percentage points from baseline resulting in an LVEF below 50%, in the absence of an alternative cause, compared between study groups.
8 secondary outcomes
Absolute change in left ventricular ejection fraction, in percentage points
Time frame: Baseline to 6 months
Minnesota Living with Heart Failure Questionnaire score
Time frame: 6 months
Six-minute walk distance (meters)
Time frame: 6 months
NT-proBNP concentration
Time frame: Baseline and 6 months
Heart failure hospitalization
Time frame: Through study follow-up (6 months)
All-cause and cardiac mortality
Time frame: Through study follow-up (6 months)
Failure of conduction system pacing (Safety)
Time frame: Through study follow-up (6 months)
Failure due to ventricular lead dislodgement or an increase in pacing threshold above 2.5 V at 1 ms.
Time frame: Through study follow-up (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 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with third parties, in accordance with the study's data protection and privacy policies and applicable data protection regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conduction System Pacing and Right Ventricular Apical Pacing in people with Atrioventricular Block and Pacing-Induced Cardiomyopathy, run by Germans Trias i Pujol Hospital 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 6 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 21 Sep 2026. 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?
Left ventricular ejection fraction at 6 months (time frame: 6 months after pacemaker implantation). The study lists 2 primary outcomes in all. 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 21 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.