BradycardiaLEFTBASHNCT04093414
Left Bundle Area Versus Selective His Bundle Pacing
A study testing Select Secure pacing lead in people with Bradycardia and Sinus Node Dysfunction, run by David Haines, MD at 2 sites in United States.
Trial summary
This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life. Patients who volunteer and are eligible for the study will be randomized to receive one of two positions for the wire to be screwed into, in addition to studying… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bradycardia, Sinus Node Dysfunction, Atrioventricular Block
- What is being tested?
- Select Secure pacing lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Oct 2019to 22 Feb 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- With signed consent.
- Pacemaker indication according to 2018 American College of Cardiology/American Heart Association/Heart Rhythm Society Guideline on the Evaluation and Management of Patients with Bradycardia and Cardiac Conduction Delay. With one or both of the following:
- Symptomatic sinus node dysfunction.
- Symptomatic Atrioventricular (AV) block or high degree AV block.
- Tachy-Brady syndrome
Who cannot join
- Previously implanted cardiac pacing devices except transvenous temporary pacemaker.
- Patients who are eligible for appropriate cardiac resynchronization therapy(CRT) or implantable cardiovert defibrillator (ICD) implantation
- Patients with prior septal myectomy
- Patients with prior surgical or transcatheter aortic valve replacement
- Anatomy precluding implant evaluated during the screening or identified during the procedure.
- Those without ability to achieve selective His bundle pacing evaluated during the screening or identified during the procedure
- Pregnant women
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beaumont Health System
Royal Oak, Michigan, 48073
Beaumont Health System
Troy, Michigan, 48085
About this study
Official title: Left Bundle Area Versus Selective His Bundle Pacing (LEFTBASH): Single Center, Open Label, Randomized Pilot Study to Evaluate Capture Thresholds and Acute Echocardiographic Hemodynamic Characteristics
This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life. Patients who volunteer and are eligible for the study will be randomized to receive one of two positions for the wire to be screwed into, in addition to studying multiple positions in the heart during the pacemaker insertion. Enrolled patients will be in the study for 1 year. They will also have an Ultrasound of their heart performed to assess how the pacemaker wire is affecting their heart. Pacemakers are connected to the heart by wires that are screwed into the heart. The wires can be connected to the heart in different places, which can affect how well the heart beats over time. The typical position is at the tip of the heart. This position may cause the heart to beat inefficiently. Over time, this could lead to weakened heart muscle, irregular heart rhythm, and more hospitalizations. The heart has special muscle cells and fibers that carry electrical signals through and around the heart. An alternative spot to place the pacemaker wire is in an area where these special cells are grouped together (called the HIS bundle). The pacemaker wire can be connected to the heart at a location which may allow the heart to beat more efficiently when compared to putting the wire at traditional spots in the heart (called HIS bundle pacing). However, sometimes connecting the wire into the HIS bundle may cause the pacemaker battery to wear out faster. Physicians can also connect the pacemaker wired near the HIS bundle (called Left left Bundle bundle area pacing). The study physicians hope this will allow the heart to beat more efficiently without causing the battery to wear out faster. The study physicians would like to study how different wire positions change heart beat efficiency and how long the pacemaker battery lasts when the wires are placed in different locations. This study will connect the pacemaker wire at either the HIS Bundle or the left bundle area pacing, to see how effectively the heart pumps and how much battery is being used.
Read the detailed description
This is a single center, open label, prospective randomized pilot study to evaluate the capture threshold of His Bundle versus left bundle area pacing. Secondary analysis will focus on changes in left ventricular performance and mechanical synchrony. Symptomatic bradyarrhythmias are effectively treated with cardiac pacemakers.The amount of pacing by the lead positioned in the bottom chamber of the heart at traditional sites such as the right ventricular apex have been associated with increased rates of atrial fibrillation, heart failure, and mortality. Traditional pacing sites result in cardiac electromechanical dyssynchrony, for which alternate pacing sites to minimize these untoward effects have been sought. HIS bundle pacing, which utilizes a patient's native conduction, has demonstrated improved electrical synchrony and left ventricular function when compared to traditional pacing at the tip of the bottom chamber. Barriers to wide spread application to this technique include the His bundle anatomic location and its attendant difficulties associated with implant, as well as higher capture thresholds leading to decreased battery duration of the pacemaker. An alternative to HIS bundle pacing is placing the lead just past the HIS bundle area, which is further in the heart, and to actively fixate the lead into the interventricular septum. This is referred to as Left Bundle Pacing, as it may electrically capture the left bundle, which would simulate a patient's native conduction. The researchers will evaluate the two different pacing sites (HIS bundle and Left Bundle area sites) to determine how effectively the heart pumps with each pacing site.
Patients requiring pacemaker implant will be screened for study eligibility and approached for informed consent. Baseline assessments including echocardiogram and ECG will be obtained. A standard of care echo done within 3 months of the procedure will be used as the baseline echo. Once enrolled, the researchers will randomize patients to one of two arms. One arm will fixate the ventricular pacemaker lead to the HIS bundle area while the other arm will have the leads fixed into the left bundle area. The pacemaker wires will be connected in accordance with randomization group. The day after the procedure, a chest x-ray, EKG and pacemaker evaluation will be performed. An echocardiogram will be obtained at 3 months post procedure. At 6 and 12 months post procedure, EKG rhythm strips will be obtained from patients' standard of care remote pacemaker monitoring systems.
- Conditions
- Bradycardia, Sinus Node Dysfunction, Atrioventricular Block
- Being tested
- Select Secure pacing lead
- Keywords
- Pacemaker, Bundle of His, Left Bundle Branch
- Medical subject headings
- Bradycardia, Sick Sinus Syndrome, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Select Secure pacing leadDevice
Also called Select Secure 3830, 69 cm, Medtronic Inc.
A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
| Study group | Role | What they receive |
|---|---|---|
| Selective or Non selective His Bundle Pacing | Active comparator | Pacemaker wires placed in Bundle of His Receives: Device: Select Secure pacing lead |
| Left Bundle Area Pacing | Active comparator | Pacemaker wires placed in Left Bundle Branch area Receives: Device: Select Secure pacing lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular Capture Threshold, 3 Months Unipolar or Bipolar
Ventricular capture threshold is the minimum amplitude of electrical signal from the pacemaker that consistently results in capture of the ventricular myocardium (normal contraction of the ventricle after electrical depolarization) with a 1.0 millisecond pulse width setting in unipolar or Bipolar output modes, measured in volts. During pacemaker placement, the ideal ventricular capture threshold is determined by delivering a series of pulses starting at 0.75 volts and increasing by 0.125 V with each trial until consistent ventricular contraction is achieved. Pacemaker settings are programmed using the ventricular capture threshold, adjusted to include a safety margin, and may be re-adjusted over time if clinically necessary. The measurement is automatically recorded within the pacemaker and will be interrogated from the pacemaker device at 3 months post implantation.
Measured: 3 months
Secondary outcomes (21)
Left Ventricular Ejection Fraction (LVEF) - Intrinsic Conduction
Percentage of blood pumped from the left ventricle of the heart at each beat with no pacing applied
Measured: at index procedure prior to lead fixation
Stroke Volume - Intrinsic Conduction
Volume of blood in milliliters pumped from the left ventricle of the heart at each beat with no pacing applied
Measured: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Anterior Left Ventricle Myocardial Wall- Intrinsic Conduction
Time to peak systolic velocity of the anterior left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler
Measured: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Inferior Left Ventricle Myocardial Wall- Intrinsic Conduction
Time to peak systolic velocity of the inferior left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler
Measured: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Inferior-septal Left Ventricle Myocardial Wall- Intrinsic Conduction
Time to peak systolic velocity of the inferior-septal left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler
Measured: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Left Ventricle Anterior-septal Myocardial Wall- Intrinsic Conduction
Time to peak systolic velocity of the left ventricle anterior-septal myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler
Measured: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Lateral Left Ventricle Myocardial Wall- Intrinsic Conduction
Time to peak systolic velocity of the lateral left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler
Measured: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Inferior-lateral Left Ventricle Myocardial Wall- Intrinsic Conduction
Time to peak systolic velocity of the inferior-lateral left ventricle myocardial wall in milliseconds with no pacing applied, elicited by tissue Doppler
Measured: at index procedure prior to lead fixation
QRS Duration - Intrinsic Conduction
Duration (time in milliseconds) of the QRS wave complex interval measured from the end of the PR interval to the end of the S wave measured on a 12-lead electrocardiogram, with intrinsic conduction (prior to implantation of the pacemaker), indicating the length of time required for the electrical depolarization of the right and left ventricles of the heart and contraction of the large ventricular muscles.
Measured: at index procedure prior to lead fixation
QRS Duration After Lead Fixation
Duration (time in milliseconds) of the QRS wave complex interval measured from the end of the PR interval to the end of the S wave measured on a 12-lead electrocardiogram, with intrinsic conduction (prior to implantation of the pacemaker), indicating the length of time required for the electrical depolarization of the right and left ventricles of the heart and contraction of the large ventricular muscles. A normal duration is between 80-100 milliseconds. A QRS duration of greater than 120 milliseconds is considered abnormal.
Measured: at index procedure following final lead fixation
Left Ventricular Ejection Fraction (LVEF) - 3 Months
LVEF is the percentage of blood pumped from the left ventricle of the heart with each beat. It is calculated as the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume). Volumes are measured via ultrasound in an echocardiogram. A healthy LVEF ranges from 50-70%. LVEF less than 40% are considered low and indicate some degree of heart failure. LVEF less than 35% are considered dangerous and indicate a subject at risk for arrhythmia.
Measured: 3 months
Stroke Volume - 3 Months
Volume of blood in milliliters pumped from the left ventricle of the heart at each beat 3 months after final pacing lead fixation
Measured: 3 months
Mechanical Dyssynchrony of Anterior Left Ventricle Myocardial Wall - 3 Months
Time to peak systolic velocity of the anterior left ventricle myocardial wall in milliseconds 3 months after final pacing lead fixation, elicited by tissue Doppler
Measured: 3 months
Mechanical Dyssynchrony of Inferior Left Ventricle Myocardial Wall - 3 Months
Time to peak systolic velocity of the inferior left ventricle myocardial wall in milliseconds 3 months after final pacing lead fixation, elicited by tissue Doppler
Measured: 3 months
Mechanical Dyssynchrony of Left Ventricle Anterior-septal Myocardial Wall - 3 Months
Time to peak systolic velocity of the left ventricle anterior-septal myocardial wall in milliseconds 3 months after final pacing lead fixation, elicited by tissue Doppler
Measured: 3 months
Mechanical Dyssynchrony of Left Ventricle Inferior-septal Myocardial Wall- 3 Months
Time to peak systolic velocity of the left ventricle inferior-septal myocardial wall in milliseconds 3 months after final pacing lead fixation, elicited by tissue Doppler
Measured: 3 months
Mechanical Dyssynchrony of Lateral Left Ventricle Myocardial Wall- 3 Months
Time to peak systolic velocity of the lateral left ventricle myocardial wall in milliseconds 3 months after final lead fixation, elicited by tissue Doppler
Measured: 3 months
Mechanical Dyssynchrony of Inferior-lateral Left Ventricle Myocardial Wall- 3 Months
Time to peak systolic velocity of the inferior-lateral left ventricle myocardial wall in milliseconds 3 months after final lead fixation, elicited by tissue Doppler
Measured: 3 months
QRS Duration- 3 Months
Duration (time in milliseconds) of the QRS wave complex interval measured from the end of the PR interval to the end of the S wave measured on a 12-lead electrocardiogram, 3 months after final pacing lead fixation, indicating the length of time required for the electrical depolarization of the right and left ventricles of the heart and contraction of the large ventricular muscles. A normal duration is between 80-100 milliseconds. A QRS duration of greater than 120 milliseconds is considered abnormal.
Measured: 3 months
Capture Threshold - 6 Months, Unipolar or Bipolar
Ventricular capture threshold is the minimum amplitude of electrical signal from the pacemaker that consistently results in capture of the ventricular myocardium (normal contraction of the ventricle after electrical depolarization) with a 1.0 millisecond pulse width setting in unipolar or Bipolar output modes, whichever value is lower, measured in volts. During pacemaker placement, the ideal ventricular capture threshold is determined by delivering a series of pulses starting at 0.75 volts and increasing by 0.125 V with each trial until consistent ventricular contraction is achieved. Pacemaker settings are programmed using the ventricular capture threshold, adjusted to include a safety margin, and may be re-adjusted over time if clinically necessary. The measurement is automatically recorded within the pacemaker and will be interrogated from the pacemaker device at 3 months post implantation.
Measured: 6 months
Capture Threshold - 12 Months, Unipolar or Bipolar
Ventricular capture threshold is the minimum amplitude of electrical signal from the pacemaker that consistently results in capture of the ventricular myocardium (normal contraction of the ventricle after electrical depolarization) with a 1.0 millisecond pulse width setting in unipolar or Bipolar output modes, whichever value is lower, measured in volts. During pacemaker placement, the ideal ventricular capture threshold is determined by delivering a series of pulses starting at 0.75 volts and increasing by 0.125 V with each trial until consistent ventricular contraction is achieved. Pacemaker settings are programmed using the ventricular capture threshold, adjusted to include a safety margin, and may be re-adjusted over time if clinically necessary. The measurement is automatically recorded within the pacemaker and will be interrogated from the pacemaker device at 3 months post implantation.
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 posted18 Sep 2019
- Study start7 Oct 2019
- Primary completion14 Feb 2022
- Study completion22 Feb 2022
Why it stopped: slow enrollment
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 BradycardiaStudies 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
- Parallel groups
- Model description
- Single center, open label, randomized, prospective
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Haines, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Haines, MD, Corewell Health East
- Investigators
- David Haines, MD, Principal investigator, Beaumont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093414
- Sponsor's protocol ID
- 2019-191
- Acronym
- LEFTBASH
- Status last verified
- Jun 2022
- First submitted
- 16 Sep 2019
- Last updated
- 17 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Bundle Area Versus Selective His Bundle Pacing (LEFTBASH): Single Center, Open Label, Randomized Pilot Study to Evaluate Capture Thresholds and Acute Echocardiographic Hemodynamic Characteristics
- ClinicalTrials.gov ID
- NCT04093414
- Acronym / sponsor ID
- LEFTBASH / 2019-191
- Conditions
- Bradycardia, Sinus Node Dysfunction, Atrioventricular Block
- Keywords
- Pacemaker, Bundle of His, Left Bundle Branch
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- David Haines, MDUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Posted 17 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a voluntary research study to find out which location in the heart a pacemaker wire is the most efficient for a patient's heart and for battery life. Patients who volunteer and are eligible for the study will be randomized to receive one of two positions for the wire to be screwed into, in addition to studying multiple positions in the heart during the pacemaker insertion. Enrolled patients will be in the study for 1 year. They will also have an Ultrasound of their heart performed to assess how the pacemaker wire is affecting their heart. Pacemakers are connected to the heart by wires that are screwed into the heart. The wires can be connected to the heart in different places, which can affect how well the heart beats over time. The typical position is at the tip of the heart. This position may cause the heart to beat inefficiently. Over time, this could lead to weakened heart muscle, irregular heart rhythm, and more hospitalizations. The heart has special muscle cells and fibers that carry electrical signals through and around the heart. An alternative spot to place the pacemaker wire is in an area where these special cells are grouped together (called the HIS bundle). The pacemaker wire can be connected to the heart at a location which may allow the heart to beat more efficiently when compared to putting the wire at traditional spots in the heart (called HIS bundle pacing). However, sometimes connecting the wire into the HIS bundle may cause the pacemaker battery to wear out faster. Physicians can also connect the pacemaker wired near the HIS bundle (called Left left Bundle bundle area pacing). The study physicians hope this will allow the heart to beat more efficiently without causing the battery to wear out faster. The study physicians would like to study how different wire positions change heart beat efficiency and how long the pacemaker battery lasts when the wires are placed in different locations. This study will connect the pacemaker wire at either the HIS Bundle or the left bundle area pacing, to see how effectively the heart pumps and how much battery is being used.
Detailed description
This is a single center, open label, prospective randomized pilot study to evaluate the capture threshold of His Bundle versus left bundle area pacing. Secondary analysis will focus on changes in left ventricular performance and mechanical synchrony. Symptomatic bradyarrhythmias are effectively treated with cardiac pacemakers.The amount of pacing by the lead positioned in the bottom chamber of the heart at traditional sites such as the right ventricular apex have been associated with increased rates of atrial fibrillation, heart failure, and mortality. Traditional pacing sites result in cardiac electromechanical dyssynchrony, for which alternate pacing sites to minimize these untoward effects have been sought. HIS bundle pacing, which utilizes a patient's native conduction, has demonstrated improved electrical synchrony and left ventricular function when compared to traditional pacing at the tip of the bottom chamber. Barriers to wide spread application to this technique include the His bundle anatomic location and its attendant difficulties associated with implant, as well as higher capture thresholds leading to decreased battery duration of the pacemaker. An alternative to HIS bundle pacing is placing the lead just past the HIS bundle area, which is further in the heart, and to actively fixate the lead into the interventricular septum. This is referred to as Left Bundle Pacing, as it may electrically capture the left bundle, which would simulate a patient's native conduction. The researchers will evaluate the two different pacing sites (HIS bundle and Left Bundle area sites) to determine how effectively the heart pumps with each pacing site.
Patients requiring pacemaker implant will be screened for study eligibility and approached for informed consent. Baseline assessments including echocardiogram and ECG will be obtained. A standard of care echo done within 3 months of the procedure will be used as the baseline echo. Once enrolled, the researchers will randomize patients to one of two arms. One arm will fixate the ventricular pacemaker lead to the HIS bundle area while the other arm will have the leads fixed into the left bundle area. The pacemaker wires will be connected in accordance with randomization group. The day after the procedure, a chest x-ray, EKG and pacemaker evaluation will be performed. An echocardiogram will be obtained at 3 months post procedure. At 6 and 12 months post procedure, EKG rhythm strips will be obtained from patients' standard of care remote pacemaker monitoring systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single center, open label, randomized, prospective
| Arm | Type | Receives |
|---|---|---|
| Selective or Non selective His Bundle Pacing | Active comparator | Device: Select Secure pacing leadPacemaker wires placed in Bundle of His |
| Left Bundle Area Pacing | Active comparator | Device: Select Secure pacing leadPacemaker wires placed in Left Bundle Branch area |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years old.
- With signed consent.
- Pacemaker indication according to 2018 American College of Cardiology/American Heart Association/Heart Rhythm Society Guideline on the Evaluation and Management of Patients with Bradycardia and Cardiac Conduction Delay. With one or both of the following:
Key exclusion criteria (7 listed)
- Previously implanted cardiac pacing devices except transvenous temporary pacemaker.
- Patients who are eligible for appropriate cardiac resynchronization therapy(CRT) or implantable cardiovert defibrillator (ICD) implantation
- Patients with prior septal myectomy
- Patients with prior surgical or transcatheter aortic valve replacement
- Anatomy precluding implant evaluated during the screening or identified during the procedure.
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 |
|---|---|---|
| Select Secure pacing leadAlso: Select Secure 3830, 69 cm, Medtronic Inc.A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization | Device | Left Bundle Area Pacing, Selective or Non selective His Bundle Pacing |
Primary outcome
Ventricular Capture Threshold, 3 Months Unipolar or Bipolar
Time frame: 3 months
Ventricular capture threshold is the minimum amplitude of electrical signal from the pacemaker that consistently results in capture of the ventricular myocardium (normal contraction of the ventricle after electrical depolarization) with a 1.0 millisecond pulse width setting in unipolar or Bipolar output modes, measured in volts. During pacemaker placement, the ideal ventricular capture threshold is determined by delivering a series of pulses starting at 0.75 volts and increasing by 0.125 V with each trial until consistent ventricular contraction is achieved. Pacemaker settings are programmed using the ventricular capture threshold, adjusted to include a safety margin, and may be re-adjusted over time if clinically necessary. The measurement is automatically recorded within the pacemaker and will be interrogated from the pacemaker device at 3 months post implantation.
21 secondary outcomes
Left Ventricular Ejection Fraction (LVEF) - Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
Stroke Volume - Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Anterior Left Ventricle Myocardial Wall- Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Inferior Left Ventricle Myocardial Wall- Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Inferior-septal Left Ventricle Myocardial Wall- Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Left Ventricle Anterior-septal Myocardial Wall- Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Lateral Left Ventricle Myocardial Wall- Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
Mechanical Dyssynchrony of Inferior-lateral Left Ventricle Myocardial Wall- Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
QRS Duration - Intrinsic Conduction
Time frame: at index procedure prior to lead fixation
QRS Duration After Lead Fixation
Time frame: at index procedure following final lead fixation
Left Ventricular Ejection Fraction (LVEF) - 3 Months
Time frame: 3 months
Stroke Volume - 3 Months
Time frame: 3 months
Mechanical Dyssynchrony of Anterior Left Ventricle Myocardial Wall - 3 Months
Time frame: 3 months
Mechanical Dyssynchrony of Inferior Left Ventricle Myocardial Wall - 3 Months
Time frame: 3 months
Mechanical Dyssynchrony of Left Ventricle Anterior-septal Myocardial Wall - 3 Months
Time frame: 3 months
Mechanical Dyssynchrony of Left Ventricle Inferior-septal Myocardial Wall- 3 Months
Time frame: 3 months
Mechanical Dyssynchrony of Lateral Left Ventricle Myocardial Wall- 3 Months
Time frame: 3 months
Mechanical Dyssynchrony of Inferior-lateral Left Ventricle Myocardial Wall- 3 Months
Time frame: 3 months
QRS Duration- 3 Months
Time frame: 3 months
Capture Threshold - 6 Months, Unipolar or Bipolar
Time frame: 6 months
Capture Threshold - 12 Months, Unipolar or Bipolar
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- 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.
David Haines, MD principal investigator
Beaumont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Select Secure pacing lead in people with Bradycardia and Sinus Node Dysfunction, run by David Haines, MD at 2 sites 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 6 inclusion and 7 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 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 17 Aug 2022). 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?
Ventricular Capture Threshold, 3 Months Unipolar or Bipolar (time frame: 3 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 17 Aug 2022.