Pulmonary Artery HypertensionNCT04194632
Right Ventricular Pacing in Pulmonary Arterial Hypertension
A study testing Temporary right ventricular pacing in people with Pulmonary Artery Hypertension and Right Ventricular Dysfunction, run by University of California, San Francisco at 1 site in United States.
Trial summary
In pulmonary arterial hypertension (PAH), progressive pulmonary vascular remodeling leads to supraphysiologic right ventricular (RV) afterload. Pharmacologic trials have shown that aggressive upfront treatment reversing pulmonary vascular remodeling successfully increases RV function and improves survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Artery Hypertension, Right Ventricular Dysfunction
- What is being tested?
- Temporary right ventricular pacing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for a clinically indicated right heart catheterization to either diagnose pulmonary arterial hypertension prior to initiating therapies or monitor response to ongoing therapies in patients with diagnosed pulmonary arterial hypertension.
- Patients with pulmonary arterial hypertension with or without significant right ventricular dysfunction as assessed by baseline echocardiography and standard of care right heart catheterization
- Functional class 2 or 3 symptoms
- Are able to undergo cardiac MRI, endocardial mapping, and pressure volume measurements
- English speaking
- All patients will be required to have evidence of right ventricular hypertrophy or conduction delay (QRS > 130ms) on surface ECG
Who cannot join
- Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/ defibrillators
- Functional class 4 symptoms
- Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension
- Contraindication to right heart catheterization including significant thrombocytopenia (platelets < 50,000), coagulopathy (INR > 1.8), or pregnancy as determined by routine screening laboratory work
- Mean pulmonary artery pressure less than 25 mmHg as determined by the right heart catheterization on the day of the study procedure
- Pulmonary capillary wedge pressure greater than or equal to 15 mmHg as determined by the right heart catheterization on the day of the study procedure
Show all 11Show fewer
- Severe tricuspid regurgitation as determined by baseline transthoracic echocardiogram.
- Left ventricular dysfunction (EF < 50%) as determined by baseline transthoracic echocardiogram.
- Inability to complete cardiac MRI or transthoracic echocardiography
- Patients with confounding systemic disease specifically portopulmonary hypertension and scleroderma associated pulmonary hypertension
- Patients otherwise deemed not appropriate for the study as determined by the study investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Benjamin Kelemen, MD, 415-476-2143, benjamin.kelemen@ucsf.edu
About this study
Official title: Right Ventricular Pacing to Treat Right Ventricular Failure: A Single Arm Hemodynamic Study
In pulmonary arterial hypertension (PAH), progressive pulmonary vascular remodeling leads to supraphysiologic right ventricular (RV) afterload. Pharmacologic trials have shown that aggressive upfront treatment reversing pulmonary vascular remodeling successfully increases RV function and improves survival. To date, however, there are no proven treatments that target RV contractile function.
Echocardiographic studies of RV dysfunction in the setting of pressure overload have demonstrated intra and interventricular dyssynchrony even in the absence of overt right bundle branch block (RBBB).
Read more
Electrophysiologic studies of patients with chronic thromboembolic disease (CTEPH) at the time of pulmonary endarterectomy have shown prolongation of action potential and slowed conduction in the right ventricle which has correlated with echocardiographic measures of dyssynchrony.
Cardiac MRI measures of RV strain in patients with PAH demonstrated simultaneous initiation of RV and left ventricular (LV) contraction, but delayed peak RV strain suggesting that interventricular dyssynchrony is a mechanical rather than electrical phenomenon.
Prior studies of RV dysfunction in an animal model, computer model, congenital heart disease, and CTEPH have suggested acute hemodynamic benefits of RV pacing. However, RV pacing has not been studied in patients with PAH. Furthermore, it remains unclear if pacing particular regions of the RV can achieve a hemodynamic benefit and what cost this hemodynamic improvement may incur with regards to myocardial energetics and wall stress.
Therefore, the investigators propose to examine RV electrical activation in PAH, map the area of latest activation, and then evaluate the hemodynamic and energetic effects of RV pacing in these patients.
Read the detailed description
Research procedures in chronological order:
- Baseline clinical variables will be prospectively determined and then obtained retrospectively from the clinical assessment of individual pulmonary hypertension team physicians via chart review. The most recent transthoracic echocardiogram will also be evaluated and routine clinical variables including tricuspid annular plane systolic excursion (TAPSE), RV fractional area change (FAC), RV outflow tract (OT) and LVOT velocity time integral (VTI), and ejection fraction (EF) will be extracted.
- All patients will have cardiac MRI performed prior to the procedure to allow precise measurement of right ventricular volumes as well as LV volumes, RVEF, and LVEF. Gadolinium enhancement using gadolinium contrast will be measured.
- Standard of care right heart catheterization (RHC) will be performed on the day of the research procedure.
- Radial arterial pressure will be used for periprocedural monitoring as well as for sampling of arterial oxygen content and arterial oxygen lactate.
- Myocardial energetics will be assessed via sampling of coronary sinus venous blood with measurement of oxygen saturation and lactate.
- Following the standard of care RHC, endocardial mapping will be performed. After pressure-volume measurements are obtained (step 7), pacing will be performed from the right atrium (RA), His bundle, and RV at the site of the latest activation with repeat measurements of pressure-volume relationships.
- Once endocardial mapping is complete, a 7-French Millar conductance catheter will be placed into the RV and used to obtain pressure-volume data for the RV using the INCA PV signal processor. The Valsalva maneuver will be used to generate a series of PV-loops reflecting preload reduction subsequently allowing for the calculation of a load independent measure of contractility, the end systolic pressure volume relationship (Ees). RV afterload will be measured as effective arterial elastance (Ea) and V-A coupling will be assessed by the ratio of Ees/Ea. Myocardial energetics will be assessed via PV area (PVA) and calculation of the transmyocardial arteriovenous oxygen extraction.
- Being tested
- Temporary right ventricular pacing
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary right ventricular pacingProcedure or surgery
As described previously. Patients will undergo temporary pacing at the site of latest endocardial activation with measurement of hemodynamic effects.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients will undergo hemodynamic measurements at baseline, with the intervention, and post-intervention thus serving as their own control. Receives: Procedure: Temporary right ventricular pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in contractility (Ees)
This is an invasive measure of the contractile strength of the right ventricle that is measured using pressure volume measurements from within the ventricle itself.
Measured: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.
Secondary outcomes (3)
Change in stroke volume
This is an invasive measure of the amount of blood ejected by the heart with each heart beat.
Measured: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.
Pressure-volume loop area
The pressure-volume loop area will be calculated to assess right ventricular myocardial oxygen consumption
Measured: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.
Coronary sinus oxygen saturation
Global myocardial oxygen consumption will also be assessed via measurement of the coronary sinus oxygen saturation.
Measured: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Jan 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As described previously, patients will undergo measurements at baseline, with pacing, and post pacing and will thus function as their own control.
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liviu Klein, MD, Principal investigator, University of California, San FranciscoBenjamin W Kelemen, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194632
- Sponsor's protocol ID
- 18-25983
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2019
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalogeropoulos AP, Georgiopoulou VV, Howell S, Pernetz MA, Fisher MR, Lerakis S, Martin RP. Evaluation of right intraventricular dyssynchrony by two-dimensional strain echocardiography in patients with pulmonary arterial hypertension. J Am Soc Echocardiogr. 2008 Sep;21(9):1028-34. doi: 10.1016/j.echo.2008.05.005. Epub 2008 Jun 16.
PubMed 18558476Hardziyenka M, Campian ME, Bouma BJ, Linnenbank AC, de Bruin-Bon HA, Kloek JJ, van der Wal AC, Baan J Jr, de Beaumont EM, Reesink HJ, de Bakker JM, Bresser P, Tan HL. Right-to-left ventricular diastolic delay in chronic thromboembolic pulmonary hypertension is associated with activation delay and action potential prolongation in right ventricle. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):555-61. doi: 10.1161/CIRCEP.109.856021. Epub 2009 Aug 4.
PubMed 19843924Marcus JT, Gan CT, Zwanenburg JJ, Boonstra A, Allaart CP, Gotte MJ, Vonk-Noordegraaf A. Interventricular mechanical asynchrony in pulmonary arterial hypertension: left-to-right delay in peak shortening is related to right ventricular overload and left ventricular underfilling. J Am Coll Cardiol. 2008 Feb 19;51(7):750-7. doi: 10.1016/j.jacc.2007.10.041.
PubMed 18279740Hardziyenka M, Surie S, de Groot JR, de Bruin-Bon HA, Knops RE, Remmelink M, Yong ZY, Baan J Jr, Bouma BJ, Bresser P, Tan HL. Right ventricular pacing improves haemodynamics in right ventricular failure from pressure overload: an open observational proof-of-principle study in patients with chronic thromboembolic pulmonary hypertension. Europace. 2011 Dec;13(12):1753-9. doi: 10.1093/europace/eur189. Epub 2011 Jul 21.
PubMed 21784747Handoko ML, Lamberts RR, Redout EM, de Man FS, Boer C, Simonides WS, Paulus WJ, Westerhof N, Allaart CP, Vonk-Noordegraaf A. Right ventricular pacing improves right heart function in experimental pulmonary arterial hypertension: a study in the isolated heart. Am J Physiol Heart Circ Physiol. 2009 Nov;297(5):H1752-9. doi: 10.1152/ajpheart.00555.2009. Epub 2009 Sep 4.
PubMed 19734361Lumens J, Arts T, Broers B, Boomars KA, van Paassen P, Prinzen FW, Delhaas T. Right ventricular free wall pacing improves cardiac pump function in severe pulmonary arterial hypertension: a computer simulation analysis. Am J Physiol Heart Circ Physiol. 2009 Dec;297(6):H2196-205. doi: 10.1152/ajpheart.00870.2009. Epub 2009 Oct 16.
PubMed 19837949Janousek J, Kovanda J, Lozek M, Tomek V, Vojtovic P, Gebauer R, Kubus P, Krejcir M, Lumens J, Delhaas T, Prinzen F. Pulmonary Right Ventricular Resynchronization in Congenital Heart Disease: Acute Improvement in Right Ventricular Mechanics and Contraction Efficiency. Circ Cardiovasc Imaging. 2017 Sep;10(9):e006424. doi: 10.1161/CIRCIMAGING.117.006424.
PubMed 28877886
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right Ventricular Pacing to Treat Right Ventricular Failure: A Single Arm Hemodynamic Study
- ClinicalTrials.gov ID
- NCT04194632
- Acronym / sponsor ID
- 18-25983
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Dec 2019 (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.
In pulmonary arterial hypertension (PAH), progressive pulmonary vascular remodeling leads to supraphysiologic right ventricular (RV) afterload. Pharmacologic trials have shown that aggressive upfront treatment reversing pulmonary vascular remodeling successfully increases RV function and improves survival. To date, however, there are no proven treatments that target RV contractile function.
Echocardiographic studies of RV dysfunction in the setting of pressure overload have demonstrated intra and interventricular dyssynchrony even in the absence of overt right bundle branch block (RBBB).
Electrophysiologic studies of patients with chronic thromboembolic disease (CTEPH) at the time of pulmonary endarterectomy have shown prolongation of action potential and slowed conduction in the right ventricle which has correlated with echocardiographic measures of dyssynchrony.
Cardiac MRI measures of RV strain in patients with PAH demonstrated simultaneous initiation of RV and left ventricular (LV) contraction, but delayed peak RV strain suggesting that interventricular dyssynchrony is a mechanical rather than electrical phenomenon.
Prior studies of RV dysfunction in an animal model, computer model, congenital heart disease, and CTEPH have suggested acute hemodynamic benefits of RV pacing. However, RV pacing has not been studied in patients with PAH. Furthermore, it remains unclear if pacing particular regions of the RV can achieve a hemodynamic benefit and what cost this hemodynamic improvement may incur with regards to myocardial energetics and wall stress.
Therefore, the investigators propose to examine RV electrical activation in PAH, map the area of latest activation, and then evaluate the hemodynamic and energetic effects of RV pacing in these patients.
Detailed description
Research procedures in chronological order:
- Baseline clinical variables will be prospectively determined and then obtained retrospectively from the clinical assessment of individual pulmonary hypertension team physicians via chart review. The most recent transthoracic echocardiogram will also be evaluated and routine clinical variables including tricuspid annular plane systolic excursion (TAPSE), RV fractional area change (FAC), RV outflow tract (OT) and LVOT velocity time integral (VTI), and ejection fraction (EF) will be extracted.
- All patients will have cardiac MRI performed prior to the procedure to allow precise measurement of right ventricular volumes as well as LV volumes, RVEF, and LVEF. Gadolinium enhancement using gadolinium contrast will be measured.
- Standard of care right heart catheterization (RHC) will be performed on the day of the research procedure.
- Radial arterial pressure will be used for periprocedural monitoring as well as for sampling of arterial oxygen content and arterial oxygen lactate.
- Myocardial energetics will be assessed via sampling of coronary sinus venous blood with measurement of oxygen saturation and lactate.
- Following the standard of care RHC, endocardial mapping will be performed. After pressure-volume measurements are obtained (step 7), pacing will be performed from the right atrium (RA), His bundle, and RV at the site of the latest activation with repeat measurements of pressure-volume relationships.
- Once endocardial mapping is complete, a 7-French Millar conductance catheter will be placed into the RV and used to obtain pressure-volume data for the RV using the INCA PV signal processor. The Valsalva maneuver will be used to generate a series of PV-loops reflecting preload reduction subsequently allowing for the calculation of a load independent measure of contractility, the end systolic pressure volume relationship (Ees). RV afterload will be measured as effective arterial elastance (Ea) and V-A coupling will be assessed by the ratio of Ees/Ea. Myocardial energetics will be assessed via PV area (PVA) and calculation of the transmyocardial arteriovenous oxygen extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As described previously, patients will undergo measurements at baseline, with pacing, and post pacing and will thus function as their own control.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Procedure: Temporary right ventricular pacingAll patients will undergo hemodynamic measurements at baseline, with the intervention, and post-intervention thus serving as their own control. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients referred for a clinically indicated right heart catheterization to either diagnose pulmonary arterial hypertension prior to initiating therapies or monitor response to ongoing therapies in patients with diagnosed pulmonary arterial hypertension.
- Patients with pulmonary arterial hypertension with or without significant right ventricular dysfunction as assessed by baseline echocardiography and standard of care right heart catheterization
- Functional class 2 or 3 symptoms
- Are able to undergo cardiac MRI, endocardial mapping, and pressure volume measurements
- English speaking
Key exclusion criteria (11 listed)
- Preexisting left bundle branch block, current atrial fibrillation, or pacemaker/ defibrillators
- Functional class 4 symptoms
- Patients treated with parenteral or subcutaneous therapies for pulmonary hypertension
- Contraindication to right heart catheterization including significant thrombocytopenia (platelets < 50,000), coagulopathy (INR > 1.8), or pregnancy as determined by routine screening laboratory work
- Mean pulmonary artery pressure less than 25 mmHg as determined by the right heart catheterization on the day of the study 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 |
|---|---|---|
| Temporary right ventricular pacingAs described previously. Patients will undergo temporary pacing at the site of latest endocardial activation with measurement of hemodynamic effects. | Procedure or surgery | Single Arm |
Primary outcome
Change in contractility (Ees)
Time frame: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.
This is an invasive measure of the contractile strength of the right ventricle that is measured using pressure volume measurements from within the ventricle itself.
3 secondary outcomes
Change in stroke volume
Time frame: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.
Pressure-volume loop area
Time frame: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.
Coronary sinus oxygen saturation
Time frame: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 18558476Kalogeropoulos AP, Georgiopoulou VV, Howell S, Pernetz MA, Fisher MR, Lerakis S, Martin RP. Evaluation of right intraventricular dyssynchrony by two-dimensional strain echocardiography in patients with pulmonary arterial hypertension. J Am Soc Echocardiogr. 2008 Sep;21(9):1028-34. doi: 10.1016/j.echo.2008.05.005. Epub 2008 Jun 16.
- Background: PubMed 19843924Hardziyenka M, Campian ME, Bouma BJ, Linnenbank AC, de Bruin-Bon HA, Kloek JJ, van der Wal AC, Baan J Jr, de Beaumont EM, Reesink HJ, de Bakker JM, Bresser P, Tan HL. Right-to-left ventricular diastolic delay in chronic thromboembolic pulmonary hypertension is associated with activation delay and action potential prolongation in right ventricle. Circ Arrhythm Electrophysiol. 2009 Oct;2(5):555-61. doi: 10.1161/CIRCEP.109.856021. Epub 2009 Aug 4.
- Background: PubMed 18279740Marcus JT, Gan CT, Zwanenburg JJ, Boonstra A, Allaart CP, Gotte MJ, Vonk-Noordegraaf A. Interventricular mechanical asynchrony in pulmonary arterial hypertension: left-to-right delay in peak shortening is related to right ventricular overload and left ventricular underfilling. J Am Coll Cardiol. 2008 Feb 19;51(7):750-7. doi: 10.1016/j.jacc.2007.10.041.
- Background: PubMed 21784747Hardziyenka M, Surie S, de Groot JR, de Bruin-Bon HA, Knops RE, Remmelink M, Yong ZY, Baan J Jr, Bouma BJ, Bresser P, Tan HL. Right ventricular pacing improves haemodynamics in right ventricular failure from pressure overload: an open observational proof-of-principle study in patients with chronic thromboembolic pulmonary hypertension. Europace. 2011 Dec;13(12):1753-9. doi: 10.1093/europace/eur189. Epub 2011 Jul 21.
- Background: PubMed 19734361Handoko ML, Lamberts RR, Redout EM, de Man FS, Boer C, Simonides WS, Paulus WJ, Westerhof N, Allaart CP, Vonk-Noordegraaf A. Right ventricular pacing improves right heart function in experimental pulmonary arterial hypertension: a study in the isolated heart. Am J Physiol Heart Circ Physiol. 2009 Nov;297(5):H1752-9. doi: 10.1152/ajpheart.00555.2009. Epub 2009 Sep 4.
- Background: PubMed 19837949Lumens J, Arts T, Broers B, Boomars KA, van Paassen P, Prinzen FW, Delhaas T. Right ventricular free wall pacing improves cardiac pump function in severe pulmonary arterial hypertension: a computer simulation analysis. Am J Physiol Heart Circ Physiol. 2009 Dec;297(6):H2196-205. doi: 10.1152/ajpheart.00870.2009. Epub 2009 Oct 16.
- Background: PubMed 28877886Janousek J, Kovanda J, Lozek M, Tomek V, Vojtovic P, Gebauer R, Kubus P, Krejcir M, Lumens J, Delhaas T, Prinzen F. Pulmonary Right Ventricular Resynchronization in Congenital Heart Disease: Acute Improvement in Right Ventricular Mechanics and Contraction Efficiency. Circ Cardiovasc Imaging. 2017 Sep;10(9):e006424. doi: 10.1161/CIRCIMAGING.117.006424.
- 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.
Liviu Klein, MD principal investigator
University of California, San Francisco
Benjamin W Kelemen, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary right ventricular pacing in people with Pulmonary Artery Hypertension and Right Ventricular Dysfunction, run by University of California, San Francisco 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Kelemen, MD (415-476-2143, Benjamin.Kelemen@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in contractility (Ees) (time frame: During procedure. The measurement will be taken pre-RV pacing, with RV pacing, and 5 minutes after RV pacing. All catheters will then be removed and the study will be completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194632, which also lists 7 linked publications.
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 2 Sep 2026.