Heart FailureNCT06298669
Biventricular Versus Right Ventricular Pacing
A study testing Biventricular Pacing and Right Ventricular Pacing in people with Heart Failure, run by Indiana University at 1 site in United States.
Trial summary
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Biventricular Pacing and Right Ventricular Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 with both an LVAD and CRT device with functional leads
- Age 18 years and older
- Ability to walk
- Ability to sign consent
Who cannot join
- Patients with permanent atrial fibrillation
- Patients who are pacemaker dependent
- Patients with sustained ventricular tachycardia
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Selection of Cardiac Resynchronization Therapy Pacing Modalities in Patients Supported by LVADs
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.
Read the detailed description
Heart failure patients with reduced left ventricular systolic function and worsening clinical status are frequently treated with mechanical devices. Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) are mainstays of advanced heart failure treatment and have independently been demonstrated to decrease mortality. However, minimal research documents the utility of these two modalities in unison. There have been recent investigations comparing Biventricular (BiV) versus right ventricular (RV) pacing suggesting better exercise performance and decreased left ventricular (LV) volumes with RV pacing. This discovery contrasts with prior meta-analysis that reports no difference between LVAD patients with and without CRT including mortality and hospitalizations. Investigators aim to compare BiV pacing and RV pacing in LVAD patients with CRT on patient's exercise tolerance and frequency of tachyarrhythmias. Additionally, research is required to form a conclusion on the role of CRT in LVAD patients.
- Conditions
- Heart Failure
- Being tested
- Biventricular Pacing, Right Ventricular Pacing
- Keywords
- Left Ventricular Assist Device (LVAD), Cardiac resynchronization therapy (CRT)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biventricular PacingDevice
The CRT device will be reprogrammed to coordinate contractions of the left and right ventricles.
Right Ventricular PacingDevice
The CRT device will be reprogrammed for right ventricular contractions.
| Study group | Role | What they receive |
|---|---|---|
| Biventricular Pacing followed by Right Ventricular Pacing | Experimental | Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. Receives: Device: Biventricular Pacing; Device: Right Ventricular Pacing |
| Right Ventricular Pacing followed by Biventricular Pacing | Experimental | Subjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to RV-first will have their CRT device reprogrammed to RV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to BiV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. Receives: Device: Biventricular Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test Performance
The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.
Measured: Baseline visit; Three-month visit
Secondary outcomes (2)
EQ-5D-3L Quality of Life Score
Quality of Life was measured using the EQ-5D-3L questionnaire. The EQ-5D-3L asks participants to rate the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated as either no problems (score of 1), some problems (score of 2), or extreme problems (score of 3). Higher scores indicating a poorer overall quality of life in these dimensions. Scores on the five dimensions are summarized to create an index score. The EQ-5D-3L index score is a numerical value that summarizes a person's health state on a scale from -0.594 to 1:
- 1: Full health
- 0 or less: Equivalent to being dead or worse than dead
The questionnaire was only completed at the baseline visit for the single participant on study.
Measured: Baseline visit
Serum NT-PRO-BNP
Serum levels of N-terminal pro-brain natriuretic peptide (NT-PRO-BNP) were measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.
Measured: Baseline visit; Three-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start9 Aug 2023
- Primary completion10 Nov 2023
- Study completion10 Nov 2023
Why it stopped: Coordinator support was lost
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Guglin, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298669
- Sponsor's protocol ID
- 16052
- Status last verified
- Nov 2024
- First submitted
- 1 Mar 2024
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of Cardiac Resynchronization Therapy Pacing Modalities in Patients Supported by LVADs
- ClinicalTrials.gov ID
- NCT06298669
- Acronym / sponsor ID
- 16052
- Conditions
- Heart Failure
- Keywords
- Left Ventricular Assist Device (LVAD), Cardiac resynchronization therapy (CRT)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Coordinator support was lost
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.
Detailed description
Heart failure patients with reduced left ventricular systolic function and worsening clinical status are frequently treated with mechanical devices. Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) are mainstays of advanced heart failure treatment and have independently been demonstrated to decrease mortality. However, minimal research documents the utility of these two modalities in unison. There have been recent investigations comparing Biventricular (BiV) versus right ventricular (RV) pacing suggesting better exercise performance and decreased left ventricular (LV) volumes with RV pacing. This discovery contrasts with prior meta-analysis that reports no difference between LVAD patients with and without CRT including mortality and hospitalizations. Investigators aim to compare BiV pacing and RV pacing in LVAD patients with CRT on patient's exercise tolerance and frequency of tachyarrhythmias. Additionally, research is required to form a conclusion on the role of CRT in LVAD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biventricular Pacing followed by Right Ventricular Pacing | Experimental | Device: Biventricular Pacing, Device: Right Ventricular PacingSubjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to BiV-first will have their CRT device reprogrammed to BiV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to RV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. |
| Right Ventricular Pacing followed by Biventricular Pacing | Experimental | Device: Biventricular PacingSubjects will be randomly assigned to the order of pacing interventions. After baseline testing (with their CRT device still in the subjects' baseline pacing modality), subjects assigned to RV-first will have their CRT device reprogrammed to RV pacing modality in the clinic. After undergoing three months of treatment in this pacing modality, they will return to clinic for retesting. The CRT device will then be reprogrammed to BiV pacing for the next 3 months. Subjects will then again return to clinic for retesting, and their CRT device will be reprogrammed to their baseline pacing modality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with both an LVAD and CRT device with functional leads
- Age 18 years and older
- Ability to walk
- Ability to sign consent
Key exclusion criteria (3 listed)
- Patients with permanent atrial fibrillation
- Patients who are pacemaker dependent
- Patients with sustained ventricular tachycardia
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 |
|---|---|---|
| Biventricular PacingThe CRT device will be reprogrammed to coordinate contractions of the left and right ventricles. | Device | Biventricular Pacing followed by Right Ventricular Pacing, Right Ventricular Pacing followed by Biventricular Pacing |
| Right Ventricular PacingThe CRT device will be reprogrammed for right ventricular contractions. | Device | Biventricular Pacing followed by Right Ventricular Pacing |
Primary outcome
6 Minute Walk Test Performance
Time frame: Baseline visit; Three-month visit
The distance walked over 6 minutes was measured at the baseline visit and the visit three months after baseline. The six month visit did not occur because the study was terminated.
2 secondary outcomes
EQ-5D-3L Quality of Life Score
Time frame: Baseline visit
Serum NT-PRO-BNP
Time frame: Baseline visit; Three-month visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Biventricular Pacing and Right Ventricular Pacing in people with Heart Failure, run by Indiana University at 1 site in United States.
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 3 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 10 Dec 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6 Minute Walk Test Performance (time frame: Baseline visit; Three-month visit). 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 10 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.