16 Participants NeededMy employer runs this trial

Right Ventricular Pacing for Pulmonary Arterial Hypertension

BK
LK
Overseen ByLiviu Klein, MD MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with pulmonary arterial hypertension (PAH), a condition where high blood pressure in the lungs strains the heart. Researchers are testing whether temporary right ventricular pacing, which uses electrical impulses on the right side of the heart, can enhance its pumping ability. The aim is to determine if this method can improve heart function without adding stress. Individuals with PAH who experience symptoms affecting daily life and can undergo specific heart tests might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for PAH.

What prior data suggests that this temporary right ventricular pacing is safe for patients with pulmonary arterial hypertension?

Previous studies have shown that temporary right ventricular (RV) pacing is generally well-tolerated by patients. For example, one study found that all patients remained safe, with no device-related problems. However, potential risks include RV perforation and cardiac tamponade, a condition where fluid accumulates around the heart, though these are uncommon. Temporary pacing typically works well but requires careful placement to prevent complications. Overall, despite some risks, temporary RV pacing is considered safe for most people.12345

Why are researchers excited about this trial?

Unlike the standard treatments for Pulmonary Arterial Hypertension (PAH), which often involve medications like vasodilators or endothelin receptor antagonists, temporary right ventricular pacing is a novel approach targeting the heart's rhythm. This technique involves using electrical impulses to optimize heart function specifically in the right ventricle, potentially improving blood flow and reducing strain on the heart. Researchers are excited because this method could offer a new way to manage PAH symptoms more effectively by directly addressing the heart's pumping efficiency, a mechanism not fully explored in current therapies.

What evidence suggests that temporary right ventricular pacing is effective for pulmonary arterial hypertension?

Research has shown that temporary pacing of the right side of the heart may benefit certain heart conditions. Studies involving animals and individuals with similar heart issues suggest that this pacing can improve blood flow in the short term. However, its effect on heart function, such as the volume of blood pumped with each beat, can vary. Temporary right heart pacing has been linked to a decrease in both the volume of blood the heart pumps and its efficiency. Additionally, there is a potential risk of increased heart failure and other complications over time. While there is potential, the effectiveness of this approach specifically for patients with pulmonary arterial hypertension remains unknown. Participants in this trial will undergo temporary right ventricular pacing to assess its impact on hemodynamic measurements.26789

Who Is on the Research Team?

LK

Liviu Klein, MD

Principal Investigator

University of California, San Francisco

BW

Benjamin W Kelemen, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with pulmonary arterial hypertension, with or without right heart dysfunction, who are having a right heart catheterization. Participants must have certain ECG changes (QRS >130ms), be able to undergo MRI and other tests, have moderate symptoms (class 2 or 3), and speak English.

Inclusion Criteria

Evidence of right ventricular hypertrophy or conduction delay (QRS > 130ms) on surface ECG
My symptoms limit my activity but I am comfortable at rest.
English speaking
See 3 more

Exclusion Criteria

Mean pulmonary artery pressure less than 25 mmHg on right heart catheterization on study day
I have a heart rhythm problem or a pacemaker/defibrillator.
Pulmonary capillary wedge pressure ≥ 15 mmHg on right heart catheterization on study day
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline clinical variables are determined, including echocardiogram and cardiac MRI to measure right ventricular volumes and function.

1 week
1 visit (in-person)

Procedure

Standard of care right heart catheterization and endocardial mapping are performed, followed by RV pacing and hemodynamic measurements.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Temporary right ventricular pacing

Trial Overview

The study is testing temporary pacing of the right side of the heart in people with pulmonary arterial hypertension to see if it improves how well their heart works. Researchers will map electrical activity and measure effects using imaging and pressure tests.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Citations

Contemporary Review of the Methods for Rapid Ventricular ...

Regardless of the definition used, all studies reported high success rates with LV pacing, ranging between 90.9% and 100% (Table 4).

Comparative analysis of direct routine left ventricular ...

Results: LV pacing demonstrated lower all-cause mortality (5.1 vs. 11.4%) and cardiovascular mortality (4.6 vs. 9.4%) at 30 days compared to RV ...

Impact of temporary right ventricular pacing from... : Europace

Right ventricular apical pacing was associated with reductions in stroke volume and LV ejection fraction (54 ± 6% AAI vs. 48 ± 5% RV apical, P= 0.001).

The Downside of Right Ventricular Apical Pacing - PMC - NIH

an elevated in-trial mortality rate of 42% compared with 12% in patients analyzed in our study.

Developments in Conventional Pacing - Harmful Effects of ...

After >10 years of RVA pacing, the prevalence of heart failure (HF) increases from 24-38% and of AF from 26-45%.9. Evidence is also available from comparisons ...

The effectiveness and safety of temporary transvenous cardiac ...

The temporary pacing lead routinely is placed into right ventricular (RV), which pose a risk of dislocation and cardiac perforation.

Safety and Feasibility of a Novel Active Fixation Temporary ...

Safety was met in all patients, with no device-related adverse events. Technical feasibility was achieved in 23 cases (92%); 2 patients had ...

Transvenous Pacing - an overview

Temporary transvenous pacing is dependable and well tolerated by patients. Typical thresholds are 20 to 120 mA, but pacing may require up to 200 mA at long ...

MRI Considerations for Patients with Temporary Epicardial ...

Temporary Epicardial Pacing Leads and Temporary Intracardiac importantly, patients do not need to be routinely screened for the presence of such leads before ...