TRISCEND vs. TRISCEND II: What I Got Wrong About My Own Trial
I have a confession. For five years, I thought I knew the name of the clinical trial that gave me the valve that saved my life.
I was wrong.
And what I learned from that mistake taught me something much bigger: patients often leave research studies with unanswered questions they don't even know to ask.
I told people I was in TRISCEND II. I wasn't. I was in TRISCEND, the early feasibility study of the EVOQUE valve. I found out when I went back to check my facts and the dates didn't match.
I received my valve in January 2021. TRISCEND II didn't start until April 2021. I couldn't have been in it.
I spent five years in this study and still didn't know the difference. Nobody ever explained it, so I never knew to ask. I doubt I'm the only patient who doesn't.
I had to go back and fix my bio, my posts, and a story I had already submitted. So here is what I learned the hard way.
Two clocks, one valve
The easiest way I found to sort it out was to put two timelines side by side. One is mine. The other belongs to the device.
My clock
Fall 2018: I was in hospice.
November 20, 2020: I was accepted into the TRISCEND study.
January 11, 2021: I received my EVOQUE valve.
March 2026: I completed my final trial visit.
The device's clock
April 2021: TRISCEND II, the larger randomized trial, began.
November 2022: One-year results from the TRISCEND study were announced.
October 2023: EVOQUE received the CE Mark in Europe.
February 2024: The FDA approved EVOQUE.
Look at where my valve sits. It was in my chest before TRISCEND II even started, and more than three years before the FDA approved it. That is what an early study means.
1. Early feasibility means early, long before FDA approval
An early feasibility study is one of the very first times a new device is tested in people. The EVOQUE valve wasn't approved by the FDA until February 2024. I received mine in January 2021, more than three years before that. There was no long-term data yet and nobody could promise me anything.
I said yes because yes was the only door that led forward. Early doesn't mean wrong for you. It means new, and you deserve to know that going in.
2. Know if you'll be randomized
In my study, there was no randomization. Everyone enrolled received the valve, and I knew I was getting it.
In a larger pivotal trial like TRISCEND II, chance decides who gets the device and who doesn't. When you've been on hospice for over two years, "chance decides" means something very real. Same valve. A very different thing to say yes to.
3. Names that sound alike can be very different studies
TRISCEND and TRISCEND II share a name and a valve. They are not the same study. One was early and everyone received the valve. The other was larger, and chance decided.
You can't ask a question you don't know exists. So here are the ones I wish someone had handed me before I signed:
"What is the exact name of this study and its registry number (its ID on ClinicalTrials.gov)? I'd like to keep it for my records."
"Has the FDA approved this yet, or is it one of the first times it's being tested in people?"
"If I join, will I definitely get the treatment, or could chance decide?"
"Is there another study with a similar name? How is mine different?"
"What don't we know yet?"
A registry number is the study's ID on ClinicalTrials.gov, the public database where studies are listed. For example, TRISCEND II is listed there as NCT04482062. Once you have the number, you can look the study up yourself and see how it is set up.
What I would do differently
If I could go back, I'd ask all five. And I'd keep a folder with everything: the study name, the registry number, the consent forms, and my notes from every visit.
Ask until the answers make sense to you. You deserve plain language from the start.
That is a big part of why I founded HeartBridge Collective. Patients and care partners should not have to learn this the hard way, and no one should have to figure it out alone.
Did you know the difference between your trial and others like it? I would love to hear your story.
This is my personal experience, not medical advice. Talk with your care team about any trial decision.
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