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Transcatheter Heart Valve
Transcatheter Aortic Valve Replacement for Aortic Stenosis (PII A Trial)
N/A
Waitlist Available
Led By Martin B Leon, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.
Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
PII A Trial Summary
This trial is testing a new heart valve to see if it is safe and effective for people with a certain heart condition.
Who is the study for?
This trial is for patients with severe, symptomatic aortic stenosis confirmed by specific echocardiographic criteria. Participants must be experiencing symptoms that affect their daily activities (NYHA Functional Class II or greater) and the heart team must agree that valve implantation will likely benefit them. Patients who've had a recent heart attack, have certain types of aortic valves, significant other valve diseases, or previous valve replacements are excluded.Check my eligibility
What is being tested?
The PARTNER II Trial is testing the safety and effectiveness of two different procedures to replace the aortic valve in patients with severe stenosis: one using the Edwards SAPIEN XT transcatheter heart valve (TAVR Implantation), and another using traditional surgical methods (SAVR Implantation).See study design
What are the potential side effects?
Potential side effects from these procedures may include bleeding, blood vessel complications, irregular heart rhythms, infection risks at the incision site or inside the body near the new valve, stroke risk during or after procedure and possible need for permanent pacemaker.
PII A Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to have heart valve surgery if required by the study.
Select...
I have symptoms from a heart valve problem and it affects my daily activities.
PII A Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
All-cause Death or Disabling Stroke to Two Years
Secondary outcome measures
6MWT Change From Baseline
Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
Effective Orifice Area (EOA)
+2 morePII A Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PIIA - SAPIEN XTExperimental Treatment1 Intervention
PIIA is operable group
Group II: Control: SAVRActive Control1 Intervention
SAVR (surgical aortic valve replacement) is the control arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAVR Implantation with SAPIEN XT
2011
N/A
~2600
Find a Location
Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
59,542 Total Patients Enrolled
Martin B Leon, MDPrincipal InvestigatorColumbia University
11 Previous Clinical Trials
9,106 Total Patients Enrolled
Craig Smith, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
2,131 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a heart attack within the past month.I had a heart procedure with a permanent implant within the last 30 days, not including pacemaker or ICD implant.I agree to follow all the study's required check-ups, including phone calls, for 5 years.My heart valve condition mainly involves severe leakage.My aortic valve is either naturally one or two flaps, or it's not hardened by calcium.A team of heart specialists has determined I cannot have heart surgery.I have severe aortic valve stenosis confirmed by an echo test within the last 60 days.You have a mechanical or bioprosthetic heart valve, except for a specific type called NR3.I agree to have heart valve surgery if required by the study.My heart team agrees a valve implant will likely help me.I have symptoms from a heart valve problem and it affects my daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: PIIA - SAPIEN XT
- Group 2: Control: SAVR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is registration for this research effort still ongoing?
"Clinicaltrials.gov reveals that this trial, initially posted on March 1st 2011 and last updated in August 29th 2022, is not actively seeking participants. However, there are 161 other clinical studies for which recruitment is currently underway."
Answered by AI
In which geographical regions is this clinical trial conducted?
"A multitude of medical centres have been listed as part of this clinical trial, such as Northwestern University in Chicago, Illinois and The Heart Hospital Baylor Plano in Dallas, Missouri. Altogether there are 57 sites operating across the United States."
Answered by AI
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