Mitral RegurgitationSTRONGNCT03104556

Silent sTROke duriNG MitraClip Implantation

An observational study of Mitral Regurgitation and Silent Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Mitral Regurgitation, Silent Stroke
How many people: 54 participants
Where: 1 siteGermany
Study dates: 14 Apr 2017to 3 Dec 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: All patients undergoing the MitraClip between April 2017 December 2019 procedure due to a severe mitral regurgitation will be enrolled in our study. All patients will be assigned to either a surgical procedure or the MitraClip-procedure by an interdisciplinary heart team according to current guidelines irrespective of this study.

Who may be able to join

Patients undergoing a MitraClip-procedure due to mitral regurgitation in the study period Written consent Procedure recommended by a Cardio-Thoracic Surgery Conference

Who cannot join

Patients who are not able to give consent Patients <18 years Participation in another interventional Trial Pregnant or lactating females Contraindication to MRI

Trial locations and contacts

1 site in 1 country.

Germany1 site

Charite
Berlin

Other trials in Germany

About this study

Official title: Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip

The MitraClip-procedure offers an interventional treatment for high risk patients with severe symptomatic mitral regurgitation. The number of new cerebral ischemic lesions without clinical manifestations is high. The aim of this study is to determine the frequency of cerebral embolisms and cerebral lesions during the MitraClip-procedure using transcranial doppler ultrasound and magnetic resonance imaging.

Read the detailed description

Mitral regurgitation is the second most common manifestation of valvular heart disease in adults. Surgical reconstruction is considered treatment of choice. For some patients the surgical risk is to high an operation is refused. For those Patients the MitraClip system (Abbott Vascular, Menlo Park, CA, USA) offers a much less invasive treatment option. Occurrence of a stroke or transient ischemic attack (TIA) is one of the potential complications during this procedure. 1% of all patients have an acute stroke. The number of new ischemic lesions without clinical manifestations is much higher (up to 85%). The impact of these lesions on the global cognitive function is unclear. The aim of this study is to determine the frequency of cerebral embolisms related to predefined procedural intervals and postprocedural cerebral lesions using Transcranial Doppler ultrasound and magnetic resonance imaging. Furthermore we want to study the correlation between cerebral embolisms seen as high intensity signals in transcranial duplex ultrasound and cerebral lesions seen in the cMRT. The results should build a basis for further studies that want to reduce the amount of cerebral lesions.

Conditions: Mitral Regurgitation, Silent Stroke
Medical subject headings: Mitral Valve Insufficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

Total amount of high intensity signals (HITS) during the predefined procedural intervals
Measured: during the procedure

Secondary outcomes (4)

Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation
Measured: 0-72h
Localizations of cerebral lesions after MitraClip-procedure
Measured: 0-72h
Incidence of peri- and postprocedural stroke
Measured: 0-72h
Incidence of delirium after MitraClip
Measured: 0-72h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 20173 Dec 2020

First posted7 Apr 2017
Study start14 Apr 2017
Primary completion3 Dec 2020
Study completion3 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03104556
Sponsor's protocol ID: STRONG-MitraClip 01
Acronym: STRONG
Status last verified: Dec 2020
First submitted: 1 Apr 2017
Last updated: 16 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Braemswig TB, Kusserow M, Bellmann B, Beckhoff F, Reinthaler M, von Rennenberg R, Erdur H, Scheitz JF, Galinovic I, Villringer K, Leistner DM, Audebert HJ, Endres M, Landmesser U, Haeusler KG, Fiebach JB, Lauten A, Rillig A, Nolte CH. New Cerebral Microbleeds After Catheter-Based Structural Heart Interventions: An Exploratory Analysis. J Am Heart Assoc. 2023 Feb 7;12(3):e8189. doi: 10.1161/JAHA.122.027284. Epub 2023 Feb 3.
PubMed 36734351

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
The PALMETTO Study
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Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease

All Mitral Regurgitation trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Silent sTROke duriNG MitraClip Implantation - STRONG-MitraClip
ClinicalTrials.gov ID: NCT03104556
Acronym / sponsor ID: STRONG / STRONG-MitraClip 01
Conditions: Mitral Regurgitation, Silent Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Charite University, Berlin, GermanyUniversity, hospital or other
Study start: 14 Apr 2017 (actual)
Primary completion: 3 Dec 2020 (actual)
Study completion: 3 Dec 2020 (actual)
First posted: 7 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients undergoing the MitraClip between April 2017 December 2019 procedure due to a severe mitral regurgitation will be enrolled in our study. All patients will be assigned to either a surgical procedure or the MitraClip-procedure by an interdisciplinary heart team according to current guidelines irrespective of this study.

Key inclusion criteria (1 listed)

Patients undergoing a MitraClip-procedure due to mitral regurgitation in the study period Written consent Procedure recommended by a Cardio-Thoracic Surgery Conference

Key exclusion criteria (1 listed)

Patients who are not able to give consent Patients <18 years Participation in another interventional Trial Pregnant or lactating females Contraindication to MRI

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Total amount of high intensity signals (HITS) during the predefined procedural intervals
Time frame: during the procedure

4 secondary outcomes

Total amount of high intensity signals and cerebral lesions related to primary and secondary mitral regurgitation
Time frame: 0-72h
Localizations of cerebral lesions after MitraClip-procedure
Time frame: 0-72h
Incidence of peri- and postprocedural stroke
Time frame: 0-72h
Incidence of delirium after MitraClip
Time frame: 0-72h

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
Derived from this study: PubMed 36734351Braemswig TB, Kusserow M, Bellmann B, Beckhoff F, Reinthaler M, von Rennenberg R, Erdur H, Scheitz JF, Galinovic I, Villringer K, Leistner DM, Audebert HJ, Endres M, Landmesser U, Haeusler KG, Fiebach JB, Lauten A, Rillig A, Nolte CH. New Cerebral Microbleeds After Catheter-Based Structural Heart Interventions: An Exploratory Analysis. J Am Heart Assoc. 2023 Feb 7;12(3):e8189. doi: 10.1161/JAHA.122.027284. Epub 2023 Feb 3.
Individual participant dataSharing planned: No

Related trials for Mitral Regurgitation

Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander Lauten, Prof. Dr. study chair

Charite Kardiologie

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Regurgitation and Silent Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total amount of high intensity signals (HITS) during the predefined procedural intervals (time frame: during the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03104556, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.