Heart BlockNCT01798043
Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
A study testing Cardiac MRI with pacemaker stimulation and Cardiac MRI with and without pacemaker stimulation in people with Heart Block and Sick Sinus Syndrome, run by Abbott Medical Devices at 1 site in Switzerland.
Trial summary
The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Block, Sick Sinus Syndrome, Atrioventricular Block
- What is being tested?
- Cardiac MRI with pacemaker stimulation and Cardiac MRI with and without pacemaker stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to Jan 2016
- 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
- Have been implanted with an Accent MRI pacemaker and Tendril MRI leads.
- Have an RV lead implanted apically (group A) or septally (Group B)
- Are RV paced for <50% of the time (groups A2 and B2)
- Are RV paced for > 50% of the time (Groups A1 and B1)
- Are ≥ 18 years of age.
- Are able to provide written informed consent.
- Are willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Who cannot join
- Have permanent atrial fibrillation with preserved intrinsic conduction
- Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
- Have a lead extender, plug or adaptor.
- Do not have an RV lead implanted apically or septally.
- Are eligible for groups A1 or B1 but appropriate group already has 20 patients enrolled.
- Are eligible for groups A2 or B2 but appropriate group already has 5 patients enrolled
Show all 10Show fewer
- Are currently participating in another device or drug investigation which includes an active treatment arm.
- Are pregnant or planning to become pregnant during the duration of the study.
- Have a life expectancy of less than 12 months from Screening due to any life-threatening condition.
- Are contraindicated for an MRI scan due to any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).
Read the detailed description
Prolonged pacing from the right ventricular (RV) Apex has been shown to be associated with progressive left ventricular (LV) dysfunction. This has led to an interest in alternative right ventricular pacing sites. Only very few studies investigated the effect of alternative right ventricular pacing sites using three dimensional imaging. Using cardiac MRI volumetric left- and right ventricular analysis and three-dimensional reconstruction is more accurate compared to trans-thoracic echocardiogram. St. Jude Medical has developed a MRI conditional pacemaker system enabling for the first time to investigate alternative pacing sites using cardiac MRI.
Patients already implanted with an MRI conditional pacemaker system from St. Jude Medical will be enrolled in that study and subdivided into 4 groups (right ventricular pacing lead positioned apically or septally subdivided in patients paced for <50% of time or 50% or more). All patients will undergo cardiac MRI at enrollment and again 12 months later. Patients paced <50% of the time will undergo cardiac MRI with and without pacemaker stimulation at both visits.
- Being tested
- Cardiac MRI with pacemaker stimulation, Cardiac MRI with and without pacemaker stimulation
- Medical subject headings
- Heart Block, Sick Sinus Syndrome, Atrioventricular Block, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI with pacemaker stimulationOther
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
Cardiac MRI with and without pacemaker stimulationOther
Patient is undergoing a Cardiac MRI at enrollment and 12 months later
| Study group | Role | What they receive |
|---|---|---|
| Septal RV lead with >50% pacing (B1) | Experimental | Cardiac MRI with pacemaker stimulation Receives: Other: Cardiac MRI with pacemaker stimulation |
| Septal RV lead with <50% pacing (B2) | Experimental | Cardiac MRI with and without pacemaker stimulation Receives: Other: Cardiac MRI with and without pacemaker stimulation |
| Apical RV lead with >50% pacing (A1) | Experimental | Cardiac MRI with pacemaker stimulation Receives: Other: Cardiac MRI with pacemaker stimulation |
| Apical RV lead with <50% pacing (A2) | Experimental | Cardiac MRI with and without pacemaker stimulation Receives: Other: Cardiac MRI with and without pacemaker stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LV chamber volumes.
Measured: 12 months (baseline to end of study)
Secondary outcomes (3)
Change in Dyssynchrony
Measured: 12 months
Change in Ejection fraction
Measured: 12 months
Change in Strain rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: Due to slow enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart BlockStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainer Zbinden, MD, Principal investigator, Triemli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798043
- Sponsor's protocol ID
- CR-12-048-CH-LV
- Status last verified
- Jul 2020
- First submitted
- 21 Feb 2013
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Septal Vs Apical Pacing on Right and Left Ventricular Performance
- ClinicalTrials.gov ID
- NCT01798043
- Acronym / sponsor ID
- CR-12-048-CH-LV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to slow enrolment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Feb 2013 (estimated)
- 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 study aims to use cardiac MRI scans and analysis techniques to evaluate differences in cardiac function after 12 months of pacing in patients with pacing leads placed in different positions within the right ventricle (apically or septally).
Detailed description
Prolonged pacing from the right ventricular (RV) Apex has been shown to be associated with progressive left ventricular (LV) dysfunction. This has led to an interest in alternative right ventricular pacing sites. Only very few studies investigated the effect of alternative right ventricular pacing sites using three dimensional imaging. Using cardiac MRI volumetric left- and right ventricular analysis and three-dimensional reconstruction is more accurate compared to trans-thoracic echocardiogram. St. Jude Medical has developed a MRI conditional pacemaker system enabling for the first time to investigate alternative pacing sites using cardiac MRI.
Patients already implanted with an MRI conditional pacemaker system from St. Jude Medical will be enrolled in that study and subdivided into 4 groups (right ventricular pacing lead positioned apically or septally subdivided in patients paced for <50% of time or 50% or more). All patients will undergo cardiac MRI at enrollment and again 12 months later. Patients paced <50% of the time will undergo cardiac MRI with and without pacemaker stimulation at both visits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Septal RV lead with >50% pacing (B1) | Experimental | Other: Cardiac MRI with pacemaker stimulationCardiac MRI with pacemaker stimulation |
| Septal RV lead with <50% pacing (B2) | Experimental | Other: Cardiac MRI with and without pacemaker stimulationCardiac MRI with and without pacemaker stimulation |
| Apical RV lead with >50% pacing (A1) | Experimental | Other: Cardiac MRI with pacemaker stimulationCardiac MRI with pacemaker stimulation |
| Apical RV lead with <50% pacing (A2) | Experimental | Other: Cardiac MRI with and without pacemaker stimulationCardiac MRI with and without pacemaker stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have been implanted with an Accent MRI pacemaker and Tendril MRI leads.
- Have an RV lead implanted apically (group A) or septally (Group B)
- Are RV paced for <50% of the time (groups A2 and B2)
- Are RV paced for > 50% of the time (Groups A1 and B1)
- Are ≥ 18 years of age.
Key exclusion criteria (10 listed)
- Have permanent atrial fibrillation with preserved intrinsic conduction
- Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
- Have a lead extender, plug or adaptor.
- Do not have an RV lead implanted apically or septally.
- Are eligible for groups A1 or B1 but appropriate group already has 20 patients enrolled.
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 |
|---|---|---|
| Cardiac MRI with pacemaker stimulationPatient is undergoing a Cardiac MRI at enrollment and 12 months later | Other | Apical RV lead with >50% pacing (A1), Septal RV lead with >50% pacing (B1) |
| Cardiac MRI with and without pacemaker stimulationPatient is undergoing a Cardiac MRI at enrollment and 12 months later | Other | Apical RV lead with <50% pacing (A2), Septal RV lead with <50% pacing (B2) |
Primary outcome
Change in LV chamber volumes.
Time frame: 12 months (baseline to end of study)
3 secondary outcomes
Change in Dyssynchrony
Time frame: 12 months
Change in Ejection fraction
Time frame: 12 months
Change in Strain rate
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Due to slow enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
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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.
Rainer Zbinden, MD principal investigator
Triemli Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI with pacemaker stimulation and Cardiac MRI with and without pacemaker stimulation in people with Heart Block and Sick Sinus Syndrome, run by Abbott Medical Devices 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 7 inclusion and 10 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 24 Jul 2020. 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. 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: Due to slow enrolment). 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?
Change in LV chamber volumes. (time frame: 12 months (baseline to end of study)). 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 24 Jul 2020.