Symptomatic First-degree Heart BlockNCT06245304
Physiologic Pacing for Symptomatic First-Degree Heart Block
A study testing Dual chamber Medtronic pacemaker implantation., DDD-50 pacing program and AAI-DDD 50 pacing program in people with Symptomatic First-degree Heart Block, run by Ascension Health at 1 site in United States.
Trial summary
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic First-degree Heart Block
- What is being tested?
- Dual chamber Medtronic pacemaker implantation., DDD-50 pacing program and AAI-DDD 50 pacing program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 30 Jun 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
- Aged 18 or above
- Ventricular Ejection Fraction (EF) > 50%
- New York Heart Association (NYHA) class II-IV
- PR interval ≥250ms
- Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm
Who cannot join
- Permanent atrial fibrillation (AF)
- Patients who are unable to perform a 6 minute hall walk
- Other serious medical condition with life expectancy of less than 1 year
- Lack of capacity to consent
- Pregnancy
- Contraindication to use of the relevant study device or leads (as per current manuals from manufacturer)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Ascension Saint Thomas Midtown
Nashville, Tennessee, 37203
Daniel Kaiser, MD, 615-329-5144, daniel.kaiser@ascension.org
About this study
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).
Read the detailed description
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). Patient will undergo a comparative effectiveness study where patients with symptomatic first-degree heart block (pr interval ≥250ms) undergo left bundle pacing (3830 lead) and are randomized to DDD-50 vs Managed Ventricular pacing-50 (MVP-50; AAI-DDD 50) and undergo a crossover at 3 months. This study will compare two standard of care options utilizing Food and Drug Administration (FDA) approved devices. Patients are evaluated at baseline, 3 months, and 6 months in terms of patient symptoms, exercise capacity, arrhythmia burden, and patient activity.
- Conditions
- Symptomatic First-degree Heart Block
- Being tested
- Dual chamber Medtronic pacemaker implantation., DDD-50 pacing program, AAI-DDD 50 pacing program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual chamber Medtronic pacemaker implantation.Device
All patients will undergo a dual chamber Medtronic pacemaker implantation meeting approved indications for pacemaker implantation per Centers for Medicare \& Medicaid Services (CMS) guidelines.
Pacemaker Model: Azure XT W1DR01. Right ventricular lead model: Medtronic 3830.
DDD-50 pacing programOther
This device programming attempts to increase the amount of ventricular pacing via the Medtronic 3830 lead. Since the enrolled patients have a prolonged PR interval, this programming attempts to synchronic atrial and ventricular contractions.
AAI-DDD 50 pacing programOther
This device programming attempts to encourage native conduction and minimize ventricular pacing via the Medtronic 3830 lead. This programming attempts to minimize ventricular pacing, which has been associated with worse outcomes by causing ventricular dyssynchrony between the left and right ventricles.
| Study group | Role | What they receive |
|---|---|---|
| DDD-50 followed by AAI-DDD 50 | Other | Patients will be programmed to DDD-50 first. After 3 months, patients will be programmed to AAI-DDD 50. Receives: Device: Dual chamber Medtronic pacemaker implantation.; Other: DDD-50 pacing program; Other: AAI-DDD 50 pacing program |
| AAI-DDD 50 followed by DDD-50 | Other | Patients will be programmed to AAI-DDD-50 first. After 3 months, patients will be programmed to DDD 50. Receives: Device: Dual chamber Medtronic pacemaker implantation.; Other: DDD-50 pacing program; Other: AAI-DDD 50 pacing program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Determine if pacemaker programming influences quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Measured: 6 months after pacemaker implantation.
Secondary outcomes (3)
Exercise capacity
Determine if pacemaker programming influences exercise capacity (6 minute hall walk, Bruce protocol, or modified Bruce protocol).
Measured: 6 months after pacemaker implantation.
Atrial fibrillation burden
Determine if pacemaker programming influences overall burden of atrial fibrillation.
Measured: 6 months after pacemaker implantation.
Patient activity
Determine if pacemaker programming influences patient activity (as measured by device accelerometer).
Measured: 6 months after pacemaker implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic First-degree 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Daniel Kaiser, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245304
- Sponsor's protocol ID
- RTN20230009
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Pacing for Symptomatic First-Degree Heart Block
- ClinicalTrials.gov ID
- NCT06245304
- Acronym / sponsor ID
- RTN20230009
- Conditions
- Symptomatic First-degree Heart Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Feb 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.
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms).
Detailed description
The purpose of this study is to determine if physiologic pacing will improve symptoms and outcomes in patients with symptomatic first-degree heart block (pr interval ≥250ms). Patient will undergo a comparative effectiveness study where patients with symptomatic first-degree heart block (pr interval ≥250ms) undergo left bundle pacing (3830 lead) and are randomized to DDD-50 vs Managed Ventricular pacing-50 (MVP-50; AAI-DDD 50) and undergo a crossover at 3 months. This study will compare two standard of care options utilizing Food and Drug Administration (FDA) approved devices. Patients are evaluated at baseline, 3 months, and 6 months in terms of patient symptoms, exercise capacity, arrhythmia burden, and patient activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDD-50 followed by AAI-DDD 50 | Other | Device: Dual chamber Medtronic pacemaker implantation., Other: DDD-50 pacing program, Other: AAI-DDD 50 pacing programPatients will be programmed to DDD-50 first. After 3 months, patients will be programmed to AAI-DDD 50. |
| AAI-DDD 50 followed by DDD-50 | Other | Device: Dual chamber Medtronic pacemaker implantation., Other: DDD-50 pacing program, Other: AAI-DDD 50 pacing programPatients will be programmed to AAI-DDD-50 first. After 3 months, patients will be programmed to DDD 50. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 or above
- Ventricular Ejection Fraction (EF) > 50%
- New York Heart Association (NYHA) class II-IV
- PR interval ≥250ms
- Narrow QRS duration (≤140ms) or prolonged QRS duration with typical Right Bundle Branch Block (RBBB) morphology on 12 lead ECG and sinus rhythm
Key exclusion criteria (6 listed)
- Permanent atrial fibrillation (AF)
- Patients who are unable to perform a 6 minute hall walk
- Other serious medical condition with life expectancy of less than 1 year
- Lack of capacity to consent
- Pregnancy
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 |
|---|---|---|
| Dual chamber Medtronic pacemaker implantation.All patients will undergo a dual chamber Medtronic pacemaker implantation meeting approved indications for pacemaker implantation per Centers for Medicare \& Medicaid Services (CMS) guidelines. Pacemaker Model: Azure XT W1DR01. Right ventricular lead model: Medtronic 3830. | Device | AAI-DDD 50 followed by DDD-50, DDD-50 followed by AAI-DDD 50 |
| DDD-50 pacing programThis device programming attempts to increase the amount of ventricular pacing via the Medtronic 3830 lead. Since the enrolled patients have a prolonged PR interval, this programming attempts to synchronic atrial and ventricular contractions. | Other | AAI-DDD 50 followed by DDD-50, DDD-50 followed by AAI-DDD 50 |
| AAI-DDD 50 pacing programThis device programming attempts to encourage native conduction and minimize ventricular pacing via the Medtronic 3830 lead. This programming attempts to minimize ventricular pacing, which has been associated with worse outcomes by causing ventricular dyssynchrony between the left and right ventricles. | Other | AAI-DDD 50 followed by DDD-50, DDD-50 followed by AAI-DDD 50 |
Primary outcome
Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Time frame: 6 months after pacemaker implantation.
Determine if pacemaker programming influences quality of life based on Minnesota Living with Heart Failure Questionnaire (MLHFQ)
3 secondary outcomes
Exercise capacity
Time frame: 6 months after pacemaker implantation.
Atrial fibrillation burden
Time frame: 6 months after pacemaker implantation.
Patient activity
Time frame: 6 months after pacemaker implantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual chamber Medtronic pacemaker implantation., DDD-50 pacing program and AAI-DDD 50 pacing program in people with Symptomatic First-degree Heart Block, run by Ascension Health 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Kaiser, MD (6153295144, daniel.kaiser@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life per the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (time frame: 6 months after pacemaker implantation.). 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 7 Feb 2024.