Pacing-Induced CardiomyopathyHis-PACENCT04672408
His Bundle Pacing Versus Right Ventricular Pacing
A study testing His bundle pacing and Right ventricular pacing in people with Pacing-Induced Cardiomyopathy, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)>40%. The primary outcome measure is LVEF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacing-Induced Cardiomyopathy
- What is being tested?
- His bundle pacing and Right ventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2021to 4 Apr 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
- Baseline LVEF>40%
- Standard pacing indication with >20% VP
- Functional His bundle lead with confirmed His capture
- Functional right ventricular lead with myocardial capture
Who cannot join
- Unable to sign an informed consent form
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Geneva
Geneva, Canton of Geneva, 1211
About this study
Official title: His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)
This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)>40%. The primary outcome measure is LVEF.
Read the detailed description
Monocentric, randomized, double-blind comparative crossover clinical study.
Patients with a standard pacing indication with >20% ventricular pacing, with a baseline LVEF >40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.
- Conditions
- Pacing-Induced Cardiomyopathy
- Being tested
- His bundle pacing, Right ventricular pacing
- Keywords
- His bundle pacing, Right ventricular pacing, Left ventricular systolic function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
His bundle pacingDevice
Pacing with capture of the His bundle
Right ventricular pacingDevice
Pacing from the right ventricular lead (septal or apical)
| Study group | Role | What they receive |
|---|---|---|
| His bundle pacing | Active comparator | Pacing programmed from the His bundle lead Receives: Device: His bundle pacing |
| Right ventricular pacing | Placebo comparator | Pacing programmed from the right ventricular lead Receives: Device: Right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Assessed by gated Equilibrium Radionuclide Angiography
Measured: 6 months
Secondary outcomes (7)
Left ventricular peak filling rate (EDV/s)
Assessed by gated Equilibrium Radionuclide Angiography
Measured: 6 months
NYHA functional class
Investigator evaluation
Measured: 6 months
6-minute walk test
Investigator evaluation
Measured: 6 months
Quality of life measure by SF-36 questionnaire
SF-36 questionnaire; 0-100 score (the higher the score, the better the quality of life)
Measured: 6 months
Right ventricular ejection fraction
Assessed by gated Equilibrium Radionuclide Angiography
Measured: 6 months
Hospital admission for cardiovascular causes
Number of days of admissions for cardiovascular causes
Measured: 6 months
Hospital admission for cardiovascular causes
Duration in days of admissions for cardiovascular causes
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Aug 2021
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Why it stopped: Slow recruitment since the advent of left bundle branch area pacing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacing-Induced CardiomyopathyStudies 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
- Crossover
- Model description
- Randomized crossover double-blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haran Burri, MD, University Hospital, Geneva
- Investigators
- Haran Burri, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672408
- Sponsor's protocol ID
- CER_GVA_2021
- Acronym
- His-PACE
- Status last verified
- Apr 2025
- First submitted
- 28 Nov 2020
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yareta data repository
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- His Bundle Pacing Versus Right Ventricular Pacing: a Randomized Crossover Study (His-PACE)
- ClinicalTrials.gov ID
- NCT04672408
- Acronym / sponsor ID
- His-PACE / CER_GVA_2021
- Conditions
- Pacing-Induced Cardiomyopathy
- Keywords
- His bundle pacing, Right ventricular pacing, Left ventricular systolic function
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment since the advent of left bundle branch area pacing
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 17 Dec 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.
This study will randomize cross-over periods of 6 months of right ventricular pacing and His bundle pacing in patients with baseline left ventricular ejection fraction (LVEF)>40%. The primary outcome measure is LVEF.
Detailed description
Monocentric, randomized, double-blind comparative crossover clinical study.
Patients with a standard pacing indication with >20% ventricular pacing, with a baseline LVEF >40%, implanted with a functioning His bundle lead and a backup right ventricular lead, will be randomized to 6-months periods of right ventricular pacing and of His bundle pacing. The primary outcome is LVEF assessed by gated Equilibrium Radionuclide Angiography. Secondary outcomes are diastolic function, New York Heart Association (NYHA) functional class, quality of life, 6-minute walk test, heart failure hospitalisations and device electrical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized crossover double-blind
| Arm | Type | Receives |
|---|---|---|
| His bundle pacing | Active comparator | Device: His bundle pacingPacing programmed from the His bundle lead |
| Right ventricular pacing | Placebo comparator | Device: Right ventricular pacingPacing programmed from the right ventricular lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Baseline LVEF>40%
- Standard pacing indication with >20% VP
- Functional His bundle lead with confirmed His capture
- Functional right ventricular lead with myocardial capture
Key exclusion criteria (1 listed)
- Unable to sign an informed consent form
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 |
|---|---|---|
| His bundle pacingPacing with capture of the His bundle | Device | His bundle pacing |
| Right ventricular pacingPacing from the right ventricular lead (septal or apical) | Device | Right ventricular pacing |
Primary outcome
Left ventricular ejection fraction
Time frame: 6 months
Assessed by gated Equilibrium Radionuclide Angiography
7 secondary outcomes
Left ventricular peak filling rate (EDV/s)
Time frame: 6 months
NYHA functional class
Time frame: 6 months
6-minute walk test
Time frame: 6 months
Quality of life measure by SF-36 questionnaire
Time frame: 6 months
Right ventricular ejection fraction
Time frame: 6 months
Hospital admission for cardiovascular causes
Time frame: 6 months
Hospital admission for cardiovascular causes
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: Slow recruitment since the advent of left bundle branch area pacing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Yes. Yareta data repository
Related trials for Pacing-Induced Cardiomyopathy
Active, not recruiting
Physiological Pacing for AV Block to Prevent Pacemaker-induced Cardiomyopathy
Conduction System Pacing, Conventional Ventricular Pacing
RecruitingObservational study
Patient Selection and Long-Term Outcomes of Pace & Ablate Strategy in Atrial Fibrillation
Atrial Fibrillation (AF), Cardiomyopathy, Secondary
RecruitingObservational study
Pacing Advancements With Cost and Experience VALuation for Unified Patient-Led Clinical Evidence - the PACEVALUE Study
Cardiomyopathy, Secondary, Arrhythmias, Cardiac
Not yet recruiting
Procedural Endpoint in Left Bundle Branch Area Pacing: Conduction System Capture Versus LV Septal Capture
Bradycardia, Atrioventricular Block
RecruitingObservational study
Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
Pacemaker-Induced Cardiomyopathy, Tricuspid Regurgitation
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.
Haran Burri, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing His bundle pacing and Right ventricular pacing in people with Pacing-Induced Cardiomyopathy, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 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: stopped early, as of the sponsor's last update on 9 Apr 2025. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Slow recruitment since the advent of left bundle branch area pacing). Results are not available in the source record.
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 (time frame: 6 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 9 Apr 2025.