Trial Summary
What is the purpose of this trial?The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Is the MitraClip device a promising treatment for mitral valve regurgitation?Yes, the MitraClip device is a promising treatment for mitral valve regurgitation. It has shown to improve symptoms and quality of life for patients who are at high risk for surgery. The latest version, MitraClip G4, offers new features that may provide better results for certain patients.278910
What safety data exists for Mitral Valve Repair vs. MitraClip Implantation for Mitral Valve Regurgitation?The provided research does not contain any safety data related to Mitral Valve Repair or MitraClip Implantation for Mitral Valve Regurgitation. The studies focus on Gamma Knife radiosurgery, pituitary adenomas, trigeminal neuralgia, and epilepsy treatments, which are unrelated to the treatments in question.145611
What data supports the idea that Mitral Valve Repair vs. MitraClip Implantation for Mitral Valve Regurgitation is an effective treatment?The available research shows that the MitraClip system, including the new G4 device, is an effective treatment for mitral valve regurgitation, especially in patients who are at high risk for surgery. The MitraClip G4 has been used successfully in patients with severe mitral regurgitation, leading to significant improvement in their condition. Over 3500 MitraClip implants have been performed worldwide, mainly in patients who cannot undergo surgery, showing its effectiveness in improving symptoms and quality of life. The MitraClip system is the only device of its kind available for this treatment, and it has been shown to improve patients' quality of life and their ability to perform daily activities.237910
Do I need to stop my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, since the trial involves heart procedures, it's possible that some medications might need to be adjusted. Please consult with the trial team for specific guidance.
Eligibility Criteria
This trial is for adults with severe primary mitral valve regurgitation who are at moderate surgical risk. Candidates must be suitable for both MitraClip device implantation and surgery, as confirmed by a heart team. They may have symptoms or certain heart function measurements that indicate treatment is needed. People with active infections, renal failure on dialysis, severe mitral annular calcification, or those needing other cardiac surgeries are excluded.Inclusion Criteria
My heart surgeon agrees I can have mitral valve surgery and my valve is right for a specific clip procedure.
I am 18 years old or older.
I have severe mitral valve regurgitation.
Exclusion Criteria
I am currently taking antibiotics for an infection.
I have severe leakage in my heart's tricuspid valve.
My femoral vein is too small for a 24 F catheter or I have an IVC filter/DVT that could interfere.
I need emergency surgery.
I do not have severe heart issues like very low blood pressure, shock, or need for heart support devices.
I have severe hardening of the heart's mitral valve ring.
I have a type of heart valve issue called secondary MR.
I have had surgery or a procedure on my mitral valve, or I have a mechanical heart valve or device.
I have been diagnosed with thickened heart muscles.
I require dialysis for kidney failure.
I need heart surgery for a valve problem.
Treatment Details
The study compares the MitraClip device implantation to traditional surgical repair in patients with severe primary mitral valve regurgitation. It's a randomized controlled trial where participants will be assigned to one of these treatments based on chance.
2Treatment groups
Experimental Treatment
Group I: Device ArmExperimental Treatment1 Intervention
MitraClip™ device implantation
Group II: Control ArmExperimental Treatment1 Intervention
Mitral Valve Repair Surgery
MitraClip™ device implantation is already approved in United States, European Union, Canada, Australia, Switzerland for the following indications:
🇺🇸 Approved in United States as MitraClip for:
- Primary mitral regurgitation (MR ≥ 3+)
- Secondary (or functional) mitral regurgitation (MR ≥ Grade III)
🇪🇺 Approved in European Union as MitraClip for:
- Primary mitral regurgitation (MR ≥ 3+)
- Secondary (or functional) mitral regurgitation (MR ≥ Grade III)
🇨🇦 Approved in Canada as MitraClip for:
- Primary mitral regurgitation (MR ≥ 3+)
- Secondary (or functional) mitral regurgitation (MR ≥ Grade III)
🇦🇺 Approved in Australia as MitraClip for:
- Primary mitral regurgitation (MR ≥ 3+)
- Secondary (or functional) mitral regurgitation (MR ≥ Grade III)
🇨🇭 Approved in Switzerland as MitraClip for:
- Primary mitral regurgitation (MR ≥ 3+)
- Secondary (or functional) mitral regurgitation (MR ≥ Grade III)
Find a clinic near you
Research locations nearbySelect from list below to view details:
UC Davis Medical CenterSacramento, CA
Saint Joseph HospitalDenver, CO
NCH Healthcare SystemNaples, FL
Yale New Haven HospitalNew Haven, CT
More Trial Locations
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Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
References
Comparing progression of non-functioning pituitary adenomas in hypopituitarism patients with and without long-term GH replacement therapy. [2016]An important safety issue with GH replacement therapy (GHRT) in hypopituitary patients with a history of a pituitary adenoma is the risk for tumour recurrence or enlargement. Design Case-control study.
Quality of life following percutaneous mitral valve repair with the MitraClip System. [2015]Percutaneous valve repair with MitraClip System is an emerging alternative for high surgical risk patients with severe mitral regurgitation (MR). QoL is a critical measure of effectiveness of this procedure. We sought to evaluate quality of life (QoL) and NYHA class following this novel procedure.
Review of the MitraClip clinical evidence. [2012]MitraClip system is the only catheter-based device for percutaneous mitral valve repair available for clinical use, after receipt of the CE Mark in 2008, while it is currently under review for FDA approval in the US. To date, over 3500 MitraClip implants have been performed worldwide, mainly in high risk surgical patients. The aim of this review is to review all the current evidences of the MitraClip therapy in an aim to define its clinical role in the treatment of mitral regurgitation (MR).
[Personalized repeat Gamma Knife Radiosurgery treatment in patients with recurrent refractory trigeminal neuralgia]. [2018]Objective: To analyze the prognosis and untoward effect in recurrent refractory trigeminal neuralgia (RRTN) patients who underwent repeat Gamma Knife Radiosurgery treatment (GKRS) retrospectively, and to summarize the experience of repeat Gamma Knife Radiosurgery treatment of recurrent refractory trigeminal neuralgia. Methods: RRTN patients who treated with repeat GKRS during 1998.8.1 to 2014.10.1 in Gamma Knife treatment Center of the Fifth Affiliated Hospital of Zhengzhou University were involved. The factors influencing long-term prognosis and facial numbness adverse reactions were statistically analyzed. Results: Therapeutic dose was an independent factor that influence long-term prognosis of RRTN patients. Therapeutic dose was a dangerous factor that influence long-term facial numbness. Interval time between twice GKRS treatment was a favorable factor for facial numbness. Long-term prognosis of repeat GKRS treatment was positively correlated with therapeutic dose. Untoward effect of facial numbness after repeat GKRS treatment was positively correlated with therapeutic dose and negatively correlated with interval time between twice GKRS treatment. Conclusions: Repeat GKRS for RRTN patients is safe and effective, but personalized treatment plan should be given according to the patient's own condition.
Repeat Gamma Knife radiosurgery versus microvascular decompression following failure of GKRS in trigeminal neuralgia: a systematic review and meta-analysis. [2019]OBJECTIVE: Gamma Knife radiosurgery (GKRS) has emerged as a promising treatment modality for patients with classical trigeminal neuralgia (TN); however, considering that almost half of the patients experience post-GKRS failure or lesion recurrence, a repeat treatment is typically necessary. The existing literature does not offer clear evidence to establish which treatment modality, repeat GKRS or microvascular decompression (MVD), is superior. The present study aimed to compare the overall outcome of patients who have undergone either repeat GKRS or MVD after failure of their primary GKRS; the authors do so by conducting a systematic review and meta-analysis of the literature and analysis of data from their own institution. METHODS: The authors conducted a systematic review and meta-analysis of the PubMed, Cochrane Library, Web of Science, and CINAHL databases to identify studies describing patients who underwent either repeat GKRS or MVD after initial failed GKRS for TN. The primary outcomes were complete pain relief (CPR) and adequate pain relief (APR) at 1 year. The secondary outcomes were rate of postoperative facial numbness and the retreatment rate. The pooled data were analyzed with R software. Bias and heterogeneity were assessed using funnel plots and I2 tests, respectively. A retrospective analysis of a series of patients treated by the authors who underwent repeat GKRS or MVD after post-GKRS failure or relapse is presented. RESULTS: A total of 22 studies met the selection criteria and were included for final data retrieval and meta-analysis. The search did not identify any study that had directly compared outcomes between patients who had undergone repeat GKRS versus those who had undergone MVD. Therefore, the authors' final analysis included two groups: studies describing outcome after repeat GKRS (n = 17) and studies describing outcome after MVD (n = 5). The authors' institutional study was the only study with direct comparison of the two cohorts. The pooled estimates of primary outcomes were APR in 83% of patients who underwent repeat GKRS and 88% of those who underwent MVD (p = 0.49), and CPR in 46% of patients who underwent repeat GKRS and 72% of those who underwent MVD (p = 0.02). The pooled estimates of secondary outcomes were facial numbness in 32% of patients who underwent repeat GKRS and 22% of those who underwent MVD (p = 0.11); the retreatment rate was 19% in patients who underwent repeat GKRS and 13% in those who underwent MVD (p = 0.74). The authors' institutional study included 42 patients (repeat GKRS in 15 and MVD in 27), and the outcomes 1 year after retreatment were APR in 80% of those who underwent repeat GKRS and 81% in those who underwent MVD (p = 1.0); CPR was achieved in 47% of those who underwent repeat GKRS and 44% in those who underwent MVD (p = 1.0). There was no difference in the rate of postoperative facial numbness or retreatment. CONCLUSIONS: The current meta-analysis failed to identify any superiority of one treatment over the other with comparable outcomes in terms of APR, postoperative facial numbness, and retreatment rates. However, MVD was shown to provide a better chance of CPR compared with repeat GKRS.
Radiation dose to neuroanatomical structures of pituitary adenomas and the effect of Gamma Knife radiosurgery on pituitary function. [2021]Gamma Knife radiosurgery (GKRS) provides a safe and effective management option for patients with all types of pituitary adenomas. The long-term adverse effects of targeted radiation to the hypothalamic-pituitary axis in relationship to radiation dose remain unclear. In this retrospective review, the authors investigated the role of differential radiation doses in predicting long-term clinical outcomes and pituitary function after GKRS for pituitary adenomas.
First-in-human report of MitraClip G4 implantation for severe degenerative mitral regurgitation. [2021]The new MitraClip G4 device (Abbott Vascular) has been recently approved by Food and Drug Administration and is currently in limited release. A patient with a large mitral regurgitation (MR) jet but a relatively small mitral valve area (MVA) was not a surgical repair candidate nor an optimal MitraClip third-generation device candidate. Therefore, we implanted the new G4 NTW device that resulted in significant MR reduction with a 57% reduction in MVA. To our knowledge, this is the first reported clinical use of the MitraClip G4 NTW device. We find that it may provide better results than a single NTR device and less reduction in MVA than two older generation devices. Further experience is needed to optimize patient selection for the four new G4 devices available.
Comparison of transcatheter tricuspid valve repair using the MitraClip NTR and XTR systems. [2021]Transcatheter tricuspid leaflet repair (TTVr) using the MitraClip is a promising option for patients with severe tricuspid regurgitation (TR) and heart failure. However, no comparative studies of the NTR and XTR systems have been reported.
Percutaneous edge-to-edge repair of severe mitral regurgitation using the MitraClip XTR versus NTR system. [2021]Transcatheter mitral valve repair (TMVR) has shown to improve symptoms and functional capacity in patients with severe mitral valve regurgitation (MR). Novel device developments provide the technology to treat patients with complex anatomies and large coaptation gaps. Nevertheless, the question of superiority of one device remains unanswered. We aimed to compare the MitraClip XTR and MitraClip NTR system in a real world setting.
Initial Experiences with the MitraClip G4: Review of the Novel Device Features. [2021]Percutaneous edge-to-edge mitral valve repair is an evolving procedure with increasing indications for use. The MitraClip™ G4 is the newest device with 4 device options, each with distinct characteristics. While the NTR and XTR clips have been in use, the G4 adds 2 new wider clips with additional features, the NTW and XTW.
[Safety and short-term efficacy of domestic magnetic resonance-guided laser interstitial thermotherapy in the treatment of drug-resistant epilepsy]. [2021]Objective: To investigate the safety and short-term efficacy of domestic magnetic resonance-guided laser interstitial thermotherapy (MRgLITT) in the treatment of drug-resistant epilepsy. Methods: Patients with drug-resistant epilepsy treated with a domestic MRgLITT system in the Department of Neurosurgery, Xuanwu Hospital, Capital Medical University from October 2020 to April 2021 were prospectively enrolled. The damage volume ratio was assessed immediately after surgery, and perioperative complications were recorded and followed up. The clinical safety and short-term efficacy were evaluated using the Engel classification. Results: A total of 22 patients were included, including 12 males and 10 females, aged from 3 to 45 years old [(24±13) years]. There were 5 cases of medial temporal lobe epilepsy (MTLE), 3 cases of hypothalamic hamartoma (HH), 7 cases of focal cortical dysplasia (FCD), and 7 cases of other types, respectively. The mean operation time and blood loss was (173±49) min and (3.7±1.6) ml. The postoperative length of hospital stay was (5.5±1.8) days, and the average damage volume ratio was 92.6%. Among them, only 2 patients (FCD of the parietal lobe) showed transient contralateral limb weakness, without any serious complications such as symptomatic intracranial hemorrhage and cerebral infarction. The follow-up time was 14 to 168 days. There were 13 Engel class Ⅰ cases (59.1%), 2 Engel class Ⅱ cases (9.1%), 2 Engel class Ⅲ cases (9.1%) and 5 Engel class Ⅳ cases (22.7%), respectively. Short-term incident-free rates were MTLE 5/5and FCD4/7, respectively. Conclusion: Domestic MRgLITT system is stable, reliable and safe in the treatment of drug-refractory epilepsy, and has better short-term efficacy in MTLE and FCD patients.