Heart Failure, Wide QRS ComplexNCT06592690
Effect of Rate-responsive Compared to VDD Pacing in Cardiac Resynchronization Therapy Recipients
A study testing Atrial pacing support and Atrial tracking pacing mode in people with Heart Failure, Wide QRS Complex, run by Ospedale Centrale Bolzano at 1 site in Italy.
Trial summary
This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Wide QRS Complex
- What is being tested?
- Atrial pacing support and Atrial tracking pacing mode
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 27 Nov 2017to 17 Sep 2021
- 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
- Patients willing to participate in the study and signing the approved Patient Informed Consent (PIC) Form;
- Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA).
- Sinus rhythm at the time of CRT device implantation with heart rate at rest above 50 bpm.
Who cannot join
- Permanent Atrial Fibrillation;
- Inability to perform 6MWT;
- Suboptimal HF drug therapy;
- Heart rate at rest above 50 bpm.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.
Read the detailed description
Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population.
Despite neutral results on hard clinical outcomes of the atrial support in CRT patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability.
The aim of this study is to assess the impact of RR pacing compare to VVD pacing in patients implanted with CRT devices in term of functional capacity, measured by the six-minute walking test (6MWT). This simple test has shown to be an independent predictors of mortality in this cohort of patients.
- Conditions
- Heart Failure, Wide QRS Complex
- Being tested
- Atrial pacing support, Atrial tracking pacing mode
- Keywords
- atrial pacing, cardiac resynchronization therapy, heart failure, implantable cardioverter defibrillator, rate-adaptive pacing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial pacing supportOther
Use a pacing mode with atrial pacing including a rate-resposive sensor.
Atrial tracking pacing modeOther
A pacing mode which allows sensing of intrinsic sinus rhythm as much as possible to avoid unnecessary atrial pacing is the preferred programming in patients with CRT without atrial pacing indication. VDD pacing mode met these criteria.
| Study group | Role | What they receive |
|---|---|---|
| VDD | Active comparator | A pacing mode which allows sensing of intrinsic sinus rhythm as much as possible to avoid unnecessary atrial pacing is the preferred programming in patients with CRT without atrial pacing indication. VDD pacing mode met these criteria. Receives: Other: Atrial tracking pacing mode |
| DDDR | Experimental | DDDR pacing mode added atrial support to these using an accelerometer-based rate-responsive sensor which should be able to increase heart rate when needed. Receives: Other: Atrial pacing support |
What is being measured
The primary outcome is the main question the study is designed to answer.
distance walked during the 6MWT
distance walked during the 6-minute-walking-test (6MWT)
Measured: A consecutive 6-month treatment period with the same pacing mode.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Nov 2017
- Primary completion17 Sep 2021
- Study completion17 Sep 2021
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 Heart Failure, Wide QRS ComplexStudies 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, cross-over, double-blind, multicenter study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Centrale Bolzano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Donazzan, Ospedale Centrale Bolzano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592690
- Sponsor's protocol ID
- 0100843-BZ
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy concerns.
Publications
Donazzan L, Bulian F, Maines M, Erckert M, Peruzza F, Rauhe WG, Giacopelli D, Manfrin M. Effect of rate-adaptive atrial support compared to VDD pacing in cardiac resynchronization therapy recipients: A randomized cross-over study. Am Heart J. 2025 Mar;281:149-156. doi: 10.1016/j.ahj.2024.12.005. Epub 2024 Dec 17.
PubMed 39701488
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rate-responsive Compared to VDD Pacing in Cardiac Resynchronization Therapy Recipients
- ClinicalTrials.gov ID
- NCT06592690
- Acronym / sponsor ID
- 0100843-BZ
- Conditions
- Heart Failure, Wide QRS Complex
- Keywords
- atrial pacing, cardiac resynchronization therapy, heart failure, implantable cardioverter defibrillator, rate-adaptive pacing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ospedale Centrale BolzanoUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 17 Sep 2021 (actual)
- First posted
- 19 Sep 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.
This study aims to understand the best programming pacing mode for cardiac resynchronization therapy devices used to treat chronic heart failure.
Detailed description
Cardiac resynchronization therapy (CRT) efficacy trials to date used atrial-synchronous biventricular pacing wherein there is no or minimal atrial pacing. However, bradycardia and chronotropic incompetence are common in this patient population.
Despite neutral results on hard clinical outcomes of the atrial support in CRT patients, it is not clear if a rate-responsive pacing may add incremental benefits on exercise capability.
The aim of this study is to assess the impact of RR pacing compare to VVD pacing in patients implanted with CRT devices in term of functional capacity, measured by the six-minute walking test (6MWT). This simple test has shown to be an independent predictors of mortality in this cohort of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, cross-over, double-blind, multicenter study
| Arm | Type | Receives |
|---|---|---|
| VDD | Active comparator | Other: Atrial tracking pacing modeA pacing mode which allows sensing of intrinsic sinus rhythm as much as possible to avoid unnecessary atrial pacing is the preferred programming in patients with CRT without atrial pacing indication. VDD pacing mode met these criteria. |
| DDDR | Experimental | Other: Atrial pacing supportDDDR pacing mode added atrial support to these using an accelerometer-based rate-responsive sensor which should be able to increase heart rate when needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients willing to participate in the study and signing the approved Patient Informed Consent (PIC) Form;
- Patients with approved indication for CRT by European Society of Cardiology/European Heart Rhythm Association guidelines (ESC/EHRA).
- Sinus rhythm at the time of CRT device implantation with heart rate at rest above 50 bpm.
Key exclusion criteria (4 listed)
- Permanent Atrial Fibrillation;
- Inability to perform 6MWT;
- Suboptimal HF drug therapy;
- Heart rate at rest above 50 bpm.
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 |
|---|---|---|
| Atrial pacing supportUse a pacing mode with atrial pacing including a rate-resposive sensor. | Other | DDDR |
| Atrial tracking pacing modeA pacing mode which allows sensing of intrinsic sinus rhythm as much as possible to avoid unnecessary atrial pacing is the preferred programming in patients with CRT without atrial pacing indication. VDD pacing mode met these criteria. | Other | VDD |
Primary outcome
distance walked during the 6MWT
Time frame: A consecutive 6-month treatment period with the same pacing mode.
distance walked during the 6-minute-walking-test (6MWT)
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 19 Sep 2024.
- Derived from this study: PubMed 39701488Donazzan L, Bulian F, Maines M, Erckert M, Peruzza F, Rauhe WG, Giacopelli D, Manfrin M. Effect of rate-adaptive atrial support compared to VDD pacing in cardiac resynchronization therapy recipients: A randomized cross-over study. Am Heart J. 2025 Mar;281:149-156. doi: 10.1016/j.ahj.2024.12.005. Epub 2024 Dec 17.
- Individual participant dataSharing planned: No. Privacy concerns.
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 Atrial pacing support and Atrial tracking pacing mode in people with Heart Failure, Wide QRS Complex, run by Ospedale Centrale Bolzano at 1 site in Italy.
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: finished, as of the sponsor's last update on 19 Sep 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 Italy. 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?
distance walked during the 6MWT (time frame: A consecutive 6-month treatment period with the same pacing mode.). 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 NCT06592690, 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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.