Right Ventricular Pacing in PAH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study involves temporary right ventricular pacing in adults with PAH and signs of right ventricular dysfunction. It uses pre-procedure cardiac MRI, standard right heart catheterization, endocardial mapping, and pacing from the right atrium, His bundle, and RV to measure changes in pressure–volume relationships. The procedures include detailed imaging, coronary sinus sampling of oxygen and lactate, and periprocedural arterial monitoring. Eligibility requires PAH with RV hypertrophy or conduction delay, and the ability to undergo MRI and mapping; exclusions include advanced disease and existing rhythm devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Where it's running

• University of California San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Liviu Klein, MD — University of California, San Francisco
• Study coordinator: Benjamin Kelemen, MD
• Email: Benjamin.Kelemen@ucsf.edu
• Phone: 415-476-2143

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.