An interventional study of Mapping and Pacing the His Bundle and Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing in Heart Failure and Left Bundle-Branch Block, sponsored by Abbott Medical Devices. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Treatment
Among 111 studies in Heart Failure by Abbott Medical Devices — 6 open to participants now, 9 under way, none of them phase 3. Heart Failure · Abbott Medical Devices.
Among the 111 studies in Heart Failure by Abbott Medical Devices, this one is the 54th largest by enrollment of the 65 interventional ones, is one of 4 that started in 2019, is one of 58 with no phase, and was the 94th registered.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's enrollment of 18 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →6 of the 111 studies in Heart Failure by Abbott Medical Devices are open now, in 12 countries. Each count lists the studies.
Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →111 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 4 started in 2019.
Median enrollment 128 across the 65 interventional studies, 143 across the 44 observational. Of the 98 that completed or were terminated, 51 (52%) have results posted.
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
3 of the studies in Heart Failure by Abbott Medical Devices that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06436053Abbott Medical DevicesAcute Response to Left Bundle Branch Area Pacing With SyncAV | 2026-12-15 |
| NCT07877805Abbott Medical DevicesMerlin Expanded ECG NSR | 2027-01 |
| NCT07217392Abbott Medical DevicesLeft Bundle Branch Area Pacing (LBBAP) PMCF Study | 2027-04-30 |
Among the 111 studies in Heart Failure by Abbott Medical Devices, from their registry updates:
This is a prospective, single-arm, non-randomized, non-blinded study designed to characterize the locations of His Bundle (HB) pacing that results in correction of electrical dyssynchrony and to characterize morphology and activation time of local intracardiac electrogram (IEGM) with an electro-anatomical mapping system during a device implant procedure and secondarily to assess the efficacy of HB pacing or HB plus LV pacing (when indicated) in correction of electrical dyssynchrony in heart failure patients with left bundle branch block.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients will be in this arm. Mapping and Pacing the His Bundle will be performed.
Procedure: Mapping and Pacing the His Bundle · Procedure: Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing
During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers.
During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers.
Successful HB pacing sites
Collect 3D Locations and electrogram characteristics (morphology and activation time) at the sites where His Bundle (HB) pacing is associated with left bundle recruitment and corrects electrical dyssynchrony at HB pacing implant procedure.
Time frame: At device implant procedure
Success rate of HB pacing
Measure success rate of HB pacing or HB plus Left ventricular (LV) pacing in the correction of electrical dyssynchrony at implant procedure;
Time frame: At device implant procedure
Ventricular activation during HB pacing
Collect ventricular activation times during HB pacing or HB plus LV pacing as compared with intrinsic rhythm and other pacing configurations at implant procedure;
Time frame: At device implant procedure
Echocardiographic measurements of LV ejection fraction
Collect echo measurements of LV ejection fraction at three-month follow-up visit
Time frame: At three-month follow-up
Echocardiographic measurements of LV end-systolic volume
Collect echo measurements of LV end-systolic volume at three-month follow-up visit
Time frame: At three-month follow-up
Capture threshold of HB pacing
Measure capture threshold in volts of HB pacing at implant and at follow-up visits post implant
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Lead impedance of HB pacing lead
Measure lead impedance in ohms of HB pacing lead at implant and at follow-up visits post implant
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
Sensing amplitude of HB pacing lead
Measure sensing amplitude in millivolts of HB pacing lead at implant and at follow-up visits post implant
Time frame: Implant procedure, up to 3 days after implant procedure, two-week follow-up visit, three-month follow-up visit
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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