Clinical trial

[Gail in Ca]

Here’s my latest update. The NP called me after the interventional cardiologist got all my records from Stanford.
He now recommends that I join an Encircle clinical trial. I’ve read about it since that call and I’m pretty sure I’m not doing a clinical trial that’s just starting. However, I did sign the paperwork for it so I can at least find out if I’m a candidate for a TMVR in the future. I feel in my gut that I wouldn’t want to be the first set of patients that would have medical people doing procedures they’ve never done before, or even employees of Edward’s showing them what to do to install this new valve. Just the animated video on the website looks very complicated!
Thankfully, my regular cardiologist told me I have time, that it’s not urgent.
I’ve also decided to get another surgical opinion or two. Well, that’s it for now.

 

[Lisa from LJ]

Here’s my latest update. The NP called me after the interventional cardiologist got all my records from Stanford.
He now recommends that I join an Encircle clinical trial. I’ve read about it since that call and I’m pretty sure I’m not doing a clinical trial that’s just starting. However, I did sign the paperwork for it so I can at least find out if I’m a candidate for a TMVR in the future. I feel in my gut that I wouldn’t want to be the first set of patients that would have medical people doing procedures they’ve never done before, or even employees of Edward’s showing them what to do to install this new valve. Just the animated video on the website looks very complicated!
Thankfully, my regular cardiologist told me I have time, that it’s not urgent.
I’ve also decided to get another surgical opinion or two. Well, that’s it for now.

Are you saying the surgeon has never done a TMVR or hasn't done one with this particular valve? If the former, I'd find a different surgeon. If the latter, I'd just make sure the surgeon had done at least a few with that valve.

 

[Gail in Ca]

Well, I need answers to my many questions about the whole clinical trial business. I’m used to a surgeon that had done a couple thousand surgeries, so do I want to let a doctor who’s done few with a new valve do mine? I do not!
Plus they puncture a hole in the heart to install it. It sounds risky to me.

 

[3mm]

Plus they puncture a hole in the heart to install it.

Gail - First, I am glad to hear from you again! I hadn't seen an update for several months, and I was worried about you. It is wonderful that you have some options!

Second, I am personally wondering about the risks of catheters passing through a hole between the left and right sides of the heart. In Nov I will get a cardiac ablation. Because I have a mechanical On-X aortic valve, the surgeon will enter my heart through the right side, then cut a hole to push the catheter into the left side of the heart where they will ablate to fix my PVCs. I have not yet talked with my radiologist about the risks, details of the procedure, etc. I will share any relevant information that I get. Unfortunately, I have not found anything online yet.

 

[dornole]

So - a clinical trial for a new TMVR valve? Are you not a candidate for one of the existing ones? My original cardiologist who did my mitral repair (now retired from clinical) was involved in this Tendyne trial starting in 2015 and it seems to now be on the market. It seems like SOMEBODY should have considerable experience with TMVR by now? : (

https://www.dicardiology.com/articl...ndation-conducts-first-us-implant-tmvr-device

The process for my balloon-based mitral valve repair required the same process of going into the right side of the heart and then a trans-septal puncture to access the left side of the heart. It was long time ago (2002) but as I recall they said there is a kind of divot where they go through where the tissue is already thin. They said there was some increased risk of stroke from putting in that hole. That is why they put me on 325 mg aspirin afterward even though I didn't otherwise need any anti-coagulation. It didn't cause me any problems and my recent cardiac CT showed that the hole is completely healed.

 

[Gail in Ca]

I need to talk to the interventional cardiologist that told me he would use an aortic valve in the mitral position and also do a lampoon procedure. I thought this was the surgery I was having. After looking at my records, he must’ve decided I wasn’t a candidate. It’s problematic for me because my cardiologist and PA both said he is the Dr I want to do the TMVR. I don’t think he does the clinical trial procedure. But, I don’t know. It just seems when a trial is starting, there’s a learning curve and I don’t want to be the patient they’re using to learn. It seems like it could be as risky as a 4th OHS, which the surgeon said was about 20%.
I just have questions so I’m calling next week to ask those questions.
I would be interested in anything about puncturing the heart.

 

[Gail in Ca]

I’m pretty sure no valves are approved for the valve in ring procedure I would need.

 

[Lisa from LJ]

Since the mitral valve is inside the heart, they have to make an incision into the left atrium to get to it with OHS. They sew it closed once the new valve is in place. I'm not understanding why that would be needed for TMVR. Don't they go directly through the vein that it will be placed in?

 

[Lisa from LJ]

https://myheart.net/articles/transcatheter-mitral-valve-in-ring-procedure-tmvir/

Have you seen this article? Looks like they've been doing the procedure for at least 6 years. I'd find a surgeon who has done several of them and get another opinion on whether or not the clinical study is right for you.

 

[dornole]

Yeah, I know your situation is complicated. : ( I wish you had more options. Totally get that you would be hesitant about a trial.

The trans-septal puncture part of it at least is not new, and is part of a few different interventional cardiology procedures. As I said I had one 22 years ago and it wasn't new then. I found this article about the risks of trans-septal puncture specifically, complications seem to be rare:

https://scai.org/transseptal-puncture-basics-and-practical-considerations

 

[3mm]

my recent cardiac CT showed that the hole is completely healed

Thank you! I know you are only a sample of 1, but it is nice to hear this from someone...

 

[Gail in Ca]

Hi all. I just got a call from the interventional cardiologist office. The np said it was determined I’m not a candidate for this procedure/trial due to a narrowed LVOT. The Dr said he could do an alcoholic septal ablation, but he felt since I’m doing okay, that it’s not urgent. So they will wait to see what comes along in the future. Whew!

 

[pellicle]

So they will wait to see what comes along in the future. Whew!

hugs mate

 

[Protimenow]

When I was stuck with an HMO and couldn't see the cardiologist I wanted to continue seeing, I went to a different practice.

They did a quick examination, then ushered me into a room where they told me about a clinical trial that they wanted me to participate. They put on a lot of pressure. I held fast. I told them that I wanted to READ anything before I sign it.

After I left, I looked over the papers that they wanted me to sign -- they were intrusive, gave control over all decisions regarding my care to the people running the trial. They required a lot of follow up visits and, essentially, wanted to take control of my life and my time.

I declined. They pushed.

I still declined.

This practice treated patients, yes, but seemed to be most active in recruiting for and running clinical trials. THIS apparently is where the big money is.

Sure, I might eventually participate in a clinical trial, but not according to the terms that THESE guys, and the trial(s) that they represent wanted me to agree to.

(I've been getting nags from Walgreens about a different clinical trial - based on one of my medications. If the thing goes badly, I don't want to leave my wife with a bad situation for her. I don't want a psychoactive medication to mess me up. No clinical trials for me, thanks)

 

[Eva]

Hi all. I just got a call from the interventional cardiologist office. The np said it was determined I’m not a candidate for this procedure/trial due to a narrowed LVOT. The Dr said he could do an alcoholic septal ablation, but he felt since I’m doing okay, that it’s not urgent. So they will wait to see what comes along in the future. Whew!

.

 

[3mm]

Gail - It is wonderful that you are doing so well!

 

[carolinemc]

When I was stuck with an HMO and couldn't see the cardiologist I wanted to continue seeing, I went to a different practice.

They did a quick examination, then ushered me into a room where they told me about a clinical trial that they wanted me to participate. They put on a lot of pressure. I held fast. I told them that I wanted to READ anything before I sign it.

After I left, I looked over the papers that they wanted me to sign -- they were intrusive, gave control over all decisions regarding my care to the people running the trial. They required a lot of follow up visits and, essentially, wanted to take control of my life and my time.

I declined. They pushed.

I still declined.

This practice treated patients, yes, but seemed to be most active in recruiting for and running clinical trials. THIS apparently is where the big money is.

Sure, I might eventually participate in a clinical trial, but not according to the terms that THESE guys, and the trial(s) that they represent wanted me to agree to.

(I've been getting nags from Walgreens about a different clinical trial - based on one of my medications. If the thing goes badly, I don't want to leave my wife with a bad situation for her. I don't want a psychoactive medication to mess me up. No clinical trials for me, thanks)

Pharmacy should not be pushing anything like clinical trials. Not their job.

 

[dornole]

Definitely rooting for you Gail! Hope the path becomes clear at the right time.

 

[Gail in Ca]

I appreciate the replies. I did feel I was being pushed to sign the paperwork. It was sent by Docusign on a Friday and I spent considerable time reading the many pages. I was specifically looking to see if I could back out at any time, which I found that I could. On Monday, a guy from the trial was already calling me wondering if I’d signed the paperwork. Before this offer of a trial I had an appointment with my own regular cardiologist and told him I felt a bit pressured and did I really need to do a procedure, yet? He apologized if he had made me feel that way and said it wasn’t urgent. He wants to see me in 4 months, so he’ll help me know when it is time to act on my leaky, repaired mitral valve.

 

[Protimenow]

The drug maker that wants to do the trial probably contacted/worked with the pharmacy to contact any of their customers who are taking a specific medication. I don't think that there's anything specifically wrong with this - although their persistence in asking me about participation in a study.

It makes sense that they would contact the pharmacies -- how else would they find people who take the specific medication for a specific ailment?

It's not much different from doctors who work with trials to find patients.

It's the push to sign subjects onto the studies that's especially annoying.