Adam's Heart Valve Surgery Blog
Double Heart Valve Surgery Patient, Adam Pick, Blogs About
Heart Valve Replacement and Heart Valve Repair Surgery

MitraClip Readies For Mitral Regurgitation Study

October 27th, 2008

If you follow the latest technology and medical advancements of heart valve surgery, I thought you would enjoy this update and video:

Evalve, Inc., a leading provider of minimally invasive mitral valve repair techniques, has completed randomized enrollment in the endovascular valve edge-to-edge repair study, which is evaluating the MitraClip system as a non-surgical repair option for patients suffering from mitral regurgitation. This study is an FDA-approved Phase II randomized, controlled, multi-center clinical research study in the US and Canada evaluating the safety and efficacy of the MitraClip device in 279 patients with moderate-to-severe mitral regurgitation.

Donald Glower, professor of surgery at Duke Medical Center and co-principal investigator of the Everest study, said: “This trial sets a high scientific standard for future mitral percutaneous valve therapies. As a result, this trial will have a significant and long-lasting impact on patient care around the world.”

Keep on tickin!

About The Author: Adam Pick is a double, heart valve surgery patient and author of The Patient's Guide To Heart Valve Surgery. This unique book integrates clinical research with the personal experiences of 135 former patients to help future patients and their caregivers better understand the problems, the opportunities and the realities of heart valve surgery. To learn more about Adam and his heart valve surgery book, click here.

10 Comments... Click here to add one.


Jon says on October 27th, 2008 at 9:18 pm

We dont know what to do now after reading this artical on Mitraclip. I am suppose to have surgery on Friday the 31st of Oct. Now I want to wait and have it done this way…is there any reason I shouldnt be doing this? I was told it could not be done robotically since there were two leaflets invloved, would it matter with the clips? Does anyone know?? Please respond ASAP.

Thanks!!

Jon

 


Adam Pick says on October 27th, 2008 at 9:24 pm

Hi Jon,

It’s Adam. You raise a good question.

However, you should that the Mitra Clip is not readily available for most patients. As of now, there is a very limited study to test this non-invasive technique for mitral valve repair in the United States.

That said, it could be years before the Mitra Clip is fully approved by the FDA and accepted by the heart valve surgery medical community.

I hope that helps. You can bring this up with your surgeon… But, my gut tells me you should proceed as planned.

Keep on tickin!

Adam

 


Vicki McFarland says on January 8th, 2009 at 11:23 pm

Dear Adam,
I am interested in the study involving the mitraclip. I have grade 3 on the echocardiagram. I have 2 leaky valves. My PCP has is providing care for me until something comes along whereby I can get treatment. I am a single mom and low income so, heart surgery is out of the question since I can not afford insurance and it would be a pre-existing condition. I have been on many medical Web sites but, have not received any solutions. I found the article on the mitraclip as an alternative for open heart surgery. I know it is not yet approved by the FDA but, isn’t that what are studies are for? I also found the study on the catheter. I would also be interested in this study. Please let me know if it is possible to qualify for a study of the above types.
Thanks,
Vicki McFarland

 


Abdullah Azam says on March 20th, 2009 at 12:56 am

Hi Adam,
I will have a Mitral valv repair surgery in London. I dont mind travelling to the US if its possible to have the MitraClip.

Please inform me if its possible.

Regards
Abdullah Azam

 


Robert Elliott says on June 10th, 2009 at 10:17 am

I am going to meet with a surgeon today about this Mitraclip surgery. My cardiologist recommended a mini sternodomy open heart mitral valve repair. I have been told this mitraclip is not FDA approved so my insurance will not pay for this but, the surgeon’s office told me if I want it done, come in and let’s try to submit it to the insurance company. Sooner or later they will pay for it or repeated submitting of this to them will hopefully get them to pay for it. Why get open heart surgery when they can repair it with this clip through one vein?

 


Robert Elliott says on August 24th, 2009 at 9:03 am

I’m late getting back to everybody but, here it is. University of Virginia is where I went to talk to the mitraclip surgeon. He told me “even though I am the surgeon and I think I will do a great job, with you not having any real symptoms, I wouldn’t jump into anything any time soon”. I said “what about my heart racing back in December”. He said “that was what…15 minutes? It needs to be a lot longer than that before worrying about it. I said what about an hour or so. He said no, a couple of days. I told him if my heart was racing for more than a day it would scare me to death. Anyway, I’ve decided to hold off for now and wait until the mitraclip is FDA approved. Unless I start feeling bad or have worsening symptoms.

 


Cindy says on January 14th, 2010 at 12:41 pm

Can you tell me if this has been approved yet by the FDA? I have a friend who is supposed to have this procedure done in February.

 


David E. Rein says on July 9th, 2010 at 7:46 am

I had a mitraclip installed on January 6, 2010. Just yesterday 7/8/2010, I had my 6 month check-up. I have experienced tremendous improvement. If you qualify for the procedure, my advice is “don’t hesitate”.

 


Sally Thornber says on December 24th, 2010 at 11:08 pm

My dad is 81 and has been approved for the Mitraclip but the procedure is not covered by Blue Cross. He lives in California and has medicare. He is in open enrollment for the next week – does anyone know which insurance companies cover this procedure???

 


Tammy Prentice says on October 14th, 2011 at 2:40 pm

My Dad needs and qualifies for a mitraclip. Any ideas on where to go to get one? Europe?

 

Leave a Reply

(required)
To prove you're a person (not a spam script), type the answer to the math equation shown in the picture. Click on the picture to hear an audio file of the equation.
Click to hear an audio file of the anti-spam equation

  #1 Recommended Book
  For Patients & Caregivers