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Procedure

PADN with Gradient Denervation System for Heart Failure (PreVail-PH2 Trial)

N/A

Recruiting

Research Sponsored by Gradient Denervation Technologies

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

NYHA Class II or III

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 1- and 6- months post-procedure

Awards & highlights

PreVail-PH2 Trial Summary

"This trial aims to understand how pulmonary artery denervation affects the quality of life in patients with heart failure and pulmonary hypertension."

Who is the study for?

This trial is for heart failure patients with a specific type of high blood pressure in the lungs (Group 2 Pulmonary Hypertension). Participants must have a certain level of heart function, kidney function, and meet other specific health measures. They should be experiencing moderate symptoms but on stable treatment.Check my eligibility

What is being tested?

The study is testing the Gradient Denervation System to see if it improves quality of life for these patients. It's an early-stage study focusing on how this procedure affects people with both heart failure and pulmonary hypertension.See study design

What are the potential side effects?

As this is an early feasibility study, detailed side effects are not provided. However, procedures like denervation could potentially cause complications such as bleeding, infection or damage to surrounding tissues.

PreVail-PH2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate heart condition symptoms.

PreVail-PH2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 1- and 6- months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 1- and 6- months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 1- and 6- months post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Device and procedure related serious adverse events

Secondary outcome measures

Change in PVR

PreVail-PH2 Trial Design

1Treatment groups

Experimental Treatment

Group I: PADN with Gradient Denervation SystemExperimental Treatment1 Intervention

Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Gradient Denervation TechnologiesLead Sponsor

1 Previous Clinical Trials

15 Total Patients Enrolled

1 Trials studying Heart Failure

15 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction for participation in this clinical trial limited to individuals below 80 years of age?

"Prospective participants for this research project must be aged between 22 and 85 years old. It is worth noting that there are a total of 74 investigations focused on individuals below the age of majority, while there are 1381 studies catering to those above the age bracket specified in our inclusion criteria."

Answered by AI

What is the current number of individuals being enrolled in this research investigation?

"Affirmative. As per clinicaltrials.gov, this research initiative is presently seeking suitable participants. Initially published on February 20th, 2024, and last revised on February 22nd, 2024, the trial aims to enroll a total of 30 patients from one designated site."

Answered by AI

Which specific criteria must individuals meet in order to qualify as potential participants for this research study?

"This research project seeks to enroll 30 individuals aged between 22 and 85 years diagnosed with heart failure. Eligible patients must fulfill the subsequent criteria: Heart Failure accompanied by an EF of at least 40% (as determined by TTE within the preceding three months), resting Mean Pulmonary Artery Pressure exceeding 20 mmHg, Glomerular Filtration Rate equal to or greater than 25 ml/min, Pulmonary Vascular Resistance at rest surpassing 3WU, resting Pulmonary Capillary Wedge Pressure above 15 mmHg or over 18 mmHg following a passive leg raise maneuver,"

Answered by AI

Are there any available positions for participants in this research study?

"Indeed, the details on clinicaltrials.gov reveal that this research study is actively seeking volunteers. Originally shared on February 20th, 2024, with the most recent update on February 22nd, 2024, the trial aims to recruit 30 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)

2024. "Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052072.

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