Nonvalvular Atrial FibrillationWATCH-TMVRNCT04494347
Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)
An observational study of Nonvalvular Atrial Fibrillation and Severe Degenerative Mitral Regurgitation, run by Mayo Clinic at 2 sites in 2 countries.
Trial summary
WATCH-TMVR (Watchman for Patients with Atrial Fibrillation Undergoing Transcatheter Mitral Valve) Clinical Trial have the main objective to assess the feasibility of combining clinically indicated MitraClip TMVR and Watchman LAAO in one setting.Mayo Clinic will be the data coordinating center for this trial, which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonvalvular Atrial Fibrillation, Severe Degenerative Mitral Regurgitation
- What is being tested?
- MitraClip TMVR and Watchman LAAO
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2020to 7 Mar 2025
- How long will I take part?
- 45 Days
- 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: Patients with severe symptomatic mitral regurgitation undergoing clinically indicated TMVr with the FDA approved MitraClip device, who also have an FDA indication for percutaneous left atrial appendage occlusion with the Watchman FLX device (atrial fibrillation + indication for long-term anticoagulation + rational to seek alternative to anticoagulation)
Who may be able to join
- Men and Women ≥ 18 years of age;
- The patient has severe symptomatic mitral regurgitation meet criteria for the commercially available MitraClip;
- The patient also has documented paroxysmal, persistent, or permanent atrial fibrillation AND The patient meets the WATCHMAN labeling guidelines;
- The patient is eligible for short-term oral anticoagulation therapy with Warfarin or a direct oral anticoagulant;
- The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial;
- The patient is able and willing to return for required follow-up visits.
Who cannot join
- Mitral valve anatomy not deemed suitable for TMVr;
- Moderate to severe mitral stenosis (mean gradient >10 mmHg or MVA <1.5 cm2);
- Contraindication for short-term anticoagulation;
- The patient has intra-cardiac thrombus as visualized by TEE within 1 week prior to Watchman procedure;
- Prior occlusion of LAA;
- Implanted mechanical mitral valve;
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- The patient requires long-term warfarin therapy due to:
- Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months.
- The patient is in a hypercoagulable state.
- Exclude the patient if per medical record documentation the patient meets any of the following criteria: • Thrombosis occurring at under 40 years age • Idiopathic or recurrent VTE (venous thromboembolism • Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins) • Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anti-coagulated;
- The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study and registries are acceptable);
- The patient is pregnant, or pregnancy is planned during the course of the investigation if patient is of child bearing potential;
- Any clinically significant medical condition or presence of any laboratory abnormality performed prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for WATCHMAN or TMVr with MitraClip;
- The patient has a life expectancy of less than one year.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
WATCH-TMVR (Watchman for Patients with Atrial Fibrillation Undergoing Transcatheter Mitral Valve) Clinical Trial have the main objective to assess the feasibility of combining clinically indicated MitraClip TMVR and Watchman LAAO in one setting.Mayo Clinic will be the data coordinating center for this trial, which will include up to 3 sites.
Read the detailed description
Left atrial appendage closure using the Watchman device procedure is approved by the FDA for patients with nonvalvular atrial fibrillation who have an indication for oral anticoagulation to reduce stroke risk but who also have a rational to seek an alternative to long-term anticoagulation (e.g., recurrent bleeding, fall risk). Transcatheter mitral valve repair with the MitraClip device is approved by the FDA for patients with severe degenerative mitral regurgitation who are deemed to be at high-risk for valve surgery and patients with severe secondary MR despite optimal medical therapy. It is also anticipated that the device will soon be approved for patients with severe symptomatic functional mitral regurgitation based on the results of the COAPT trials. Atrial fibrillation is common in patients referred for TMVr. A recent study from the Mayo Clinic documented that up to 50% of patients undergoing TMVr might qualify for LAA based on their risk assessment. Both procedures are performed via a large bore femoral venous access, and utilize transseptal puncture, general anesthesia, and transesophageal echo guidance. Hence, combining the two procedures in one session might provide incremental benefit to those patients by avoiding the risk of repeated large-bore access, transseptal puncture, and general anesthesia. A limited number of case reports illustrated the safety and feasibility of a combined TMVr with LAAO when clinically indicated. Experience with combined TMVr/LAAO in the United States is limited, mostly due to the lack of supportive data and concerns about the incremental cost of the Watchman device that might not be covered by the Center for Medicare Services (CMS) per current guidelines.
- Being tested
- MitraClip TMVR and Watchman LAAO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraClip TMVR and Watchman LAAOProcedure or surgery
The MitraClip device is a percutaneous edge-to-edge repair device that is intended to approximate the anterior and posterior mitral valve leaflets in patients with severe symptomatic mitral regurgitation with suitable anatomy. Device versions/types: MitraClip NTr, MitraClip XTr. The WATCHMAN device is a self-expanding left atrial appendage occlusion (LAAO) device with a porous covering on the proximal face. Device sizes: 21 mm, 24 mm, 27 mm, 30 mm, 33 mm.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | This is not a randomized study. Patients who are clinically indicated for both procedures will be offered the option to enroll in this registry for a combined procedure. Otherwise, they will undergo TMVr and LAAO in two separate session as clinically indicated (standard of care). Receives: Procedure: MitraClip TMVR and Watchman LAAO |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality rate
Total number of Subject's Death
Measured: 45 days post procedure
All-cause mortality rate
Total number of Subject's Death
Measured: 1 Year post procedure
Serious Adverse Events (SAEs)
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
Measured: 45 days post procedure
Serious Adverse Events (SAEs)
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
Measured: 1 Year post procedure
Secondary outcomes (1)
SAEs related to the Study devices
Total number of the Subject's to experience SAEs as related to Watchman and the LAAO devices.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start1 Nov 2020
- Primary completion7 Mar 2025
- Study completion7 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvalvular Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 25 participants (actual)
- Target duration
- 45 Days
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Adnan Alkhouli, Mayo Clinic
- Investigators
- Mohamad Adnan (Mohamad) Alkhouli, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494347
- Sponsor's protocol ID
- 19-010047
- Acronym
- WATCH-TMVR
- Status last verified
- Feb 2026
- First submitted
- 1 Jul 2020
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)
- ClinicalTrials.gov ID
- NCT04494347
- Acronym / sponsor ID
- WATCH-TMVR / 19-010047
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 7 Mar 2025 (actual)
- Study completion
- 7 Mar 2025 (actual)
- First posted
- 31 Jul 2020 (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.
WATCH-TMVR (Watchman for Patients with Atrial Fibrillation Undergoing Transcatheter Mitral Valve) Clinical Trial have the main objective to assess the feasibility of combining clinically indicated MitraClip TMVR and Watchman LAAO in one setting.Mayo Clinic will be the data coordinating center for this trial, which will include up to 3 sites.
Detailed description
Left atrial appendage closure using the Watchman device procedure is approved by the FDA for patients with nonvalvular atrial fibrillation who have an indication for oral anticoagulation to reduce stroke risk but who also have a rational to seek an alternative to long-term anticoagulation (e.g., recurrent bleeding, fall risk). Transcatheter mitral valve repair with the MitraClip device is approved by the FDA for patients with severe degenerative mitral regurgitation who are deemed to be at high-risk for valve surgery and patients with severe secondary MR despite optimal medical therapy. It is also anticipated that the device will soon be approved for patients with severe symptomatic functional mitral regurgitation based on the results of the COAPT trials. Atrial fibrillation is common in patients referred for TMVr. A recent study from the Mayo Clinic documented that up to 50% of patients undergoing TMVr might qualify for LAA based on their risk assessment. Both procedures are performed via a large bore femoral venous access, and utilize transseptal puncture, general anesthesia, and transesophageal echo guidance. Hence, combining the two procedures in one session might provide incremental benefit to those patients by avoiding the risk of repeated large-bore access, transseptal puncture, and general anesthesia. A limited number of case reports illustrated the safety and feasibility of a combined TMVr with LAAO when clinically indicated. Experience with combined TMVr/LAAO in the United States is limited, mostly due to the lack of supportive data and concerns about the incremental cost of the Watchman device that might not be covered by the Center for Medicare Services (CMS) per current guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 45 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Procedure: MitraClip TMVR and Watchman LAAOThis is not a randomized study. Patients who are clinically indicated for both procedures will be offered the option to enroll in this registry for a combined procedure. Otherwise, they will undergo TMVr and LAAO in two separate session as clinically indicated (standard of care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe symptomatic mitral regurgitation undergoing clinically indicated TMVr with the FDA approved MitraClip device, who also have an FDA indication for percutaneous left atrial appendage occlusion with the Watchman FLX device (atrial fibrillation + indication for long-term anticoagulation + rational to seek alternative to anticoagulation)
Key inclusion criteria (6 listed)
- Men and Women ≥ 18 years of age;
- The patient has severe symptomatic mitral regurgitation meet criteria for the commercially available MitraClip;
- The patient also has documented paroxysmal, persistent, or permanent atrial fibrillation AND The patient meets the WATCHMAN labeling guidelines;
- The patient is eligible for short-term oral anticoagulation therapy with Warfarin or a direct oral anticoagulant;
- The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial;
Key exclusion criteria (14 listed)
- Mitral valve anatomy not deemed suitable for TMVr;
- Moderate to severe mitral stenosis (mean gradient >10 mmHg or MVA <1.5 cm2);
- Contraindication for short-term anticoagulation;
- The patient has intra-cardiac thrombus as visualized by TEE within 1 week prior to Watchman procedure;
- Prior occlusion of LAA;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MitraClip TMVR and Watchman LAAOThe MitraClip device is a percutaneous edge-to-edge repair device that is intended to approximate the anterior and posterior mitral valve leaflets in patients with severe symptomatic mitral regurgitation with suitable anatomy. Device versions/types: MitraClip NTr, MitraClip XTr. The WATCHMAN device is a self-expanding left atrial appendage occlusion (LAAO) device with a porous covering on the proximal face. Device sizes: 21 mm, 24 mm, 27 mm, 30 mm, 33 mm. | Procedure or surgery | Treatment Group |
Primary outcome
All-cause mortality rate
Time frame: 45 days post procedure
Total number of Subject's Death
All-cause mortality rate
Time frame: 1 Year post procedure
Total number of Subject's Death
Serious Adverse Events (SAEs)
Time frame: 45 days post procedure
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
Serious Adverse Events (SAEs)
Time frame: 1 Year post procedure
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
1 secondary outcome
SAEs related to the Study devices
Time frame: 1 Year
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 1 May 2026.
- Individual participant dataSharing planned: No
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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.
Mohamad Adnan (Mohamad) Alkhouli, MD principal investigator
Mayo Clinic
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonvalvular Atrial Fibrillation and Severe Degenerative Mitral Regurgitation, run by Mayo Clinic at 2 sites in 2 countries.
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 6 inclusion and 14 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
All-cause mortality rate (time frame: 45 days post procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.