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Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR) (WATCH-TMVR)

Primary Purpose

Nonvalvular Atrial Fibrillation, Severe Degenerative Mitral Regurgitation

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MitraClip TMVR and Watchman LAAO
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonvalvular Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men and Women ≥ 18 years of age;
  2. The patient has severe symptomatic mitral regurgitation meet criteria for the commercially available MitraClip;
  3. The patient also has documented paroxysmal, persistent, or permanent atrial fibrillation AND The patient meets the WATCHMAN labeling guidelines;
  4. The patient is eligible for short-term oral anticoagulation therapy with Warfarin or a direct oral anticoagulant;
  5. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial;
  6. The patient is able and willing to return for required follow-up visits.

Exclusion Criteria:

  1. Mitral valve anatomy not deemed suitable for TMVr;
  2. Moderate to severe mitral stenosis (mean gradient >10 mmHg or MVA <1.5 cm2);
  3. Contraindication for short-term anticoagulation;
  4. The patient has intra-cardiac thrombus as visualized by TEE within 1 week prior to Watchman procedure;
  5. Prior occlusion of LAA;
  6. Implanted mechanical mitral valve;
  7. The patient requires long-term warfarin therapy due to:

    1. Secondary to conditions such as prior arterial embolism or other indications such as pulmonary embolism or deep vein thrombosis within the previous 6 months.
    2. The patient is in a hypercoagulable state.
  8. 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;
  9. The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study and registries are acceptable);
  10. The patient is pregnant, or pregnancy is planned during the course of the investigation if patient is of child bearing potential;
  11. 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;
  12. The patient has a life expectancy of less than one year.

Sites / Locations

  • Mayo ClinicRecruiting
  • Ottawa Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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).

Outcomes

Primary Outcome Measures

All-cause mortality rate
Total number of Subject's Death
All-cause mortality rate
Total number of Subject's Death
Serious Adverse Events (SAEs)
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
Serious Adverse Events (SAEs)
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.

Secondary Outcome Measures

SAEs related to the Study devices
Total number of the Subject's to experience SAEs as related to Watchman and the LAAO devices.

Full Information

First Posted
July 1, 2020
Last Updated
October 9, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04494347
Brief Title
Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)
Acronym
WATCH-TMVR
Official Title
Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonvalvular Atrial Fibrillation, Severe Degenerative Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective multicenter registry of 25 patients who are planned to undergo TMVr with MitraClip and also have an indication for LAAO with the commercially available WATCHMAN device. All patients will undergo TMVr first under general anesthesia and transesophageal echo (TEE) guidance. At the conclusion of the TMVr procedure, the patient will undergo LAAO with the Watchman device using the same transseptal access the was obtained to perform the TMVr. Patients will receive oral anticoagulation with warfarin (or a direct anticoagulant) and subsequent antiplatelet therapy as per standard of care and outlined in protocol for 6 weeks. After 6 weeks, patients will have TEE done as per standard of care in addition to office visit and complete clinical and neurological evaluation. Continuation or discontinuation of oral anticoagulation will depend on the 45-day TEE findings. The anticipated duration of the Clinical Investigation will be 12 months.
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
MitraClip TMVR and Watchman LAAO
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause mortality rate
Description
Total number of Subject's Death
Time Frame
45 days post procedure
Title
All-cause mortality rate
Description
Total number of Subject's Death
Time Frame
1 Year post procedure
Title
Serious Adverse Events (SAEs)
Description
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
Time Frame
45 days post procedure
Title
Serious Adverse Events (SAEs)
Description
Total number of Subject's experiencing SAEs such Stroke, life-threatening or major bleeding.
Time Frame
1 Year post procedure
Secondary Outcome Measure Information:
Title
SAEs related to the Study devices
Description
Total number of the Subject's to experience SAEs as related to Watchman and the LAAO devices.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad Adnan (Mohamad) Alkhouli, MD
Phone
507-255-2504
Email
alkhouli.mohamad@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Adnan (Mohamad) Alkhouli, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Griffin
Phone
507-255-5690
Email
GriffinII.Carl@mayo.edu
First Name & Middle Initial & Last Name & Degree
Anna Reed
Phone
(507) 255-0337
Email
Reed.Anna@mayo.edu
First Name & Middle Initial & Last Name & Degree
Mohamad Alkhouli, MD
Facility Name
Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Feagan
Phone
613-696-7000
Ext
12678
Email
hfeagan@ottawaheart.ca
First Name & Middle Initial & Last Name & Degree
Benjamin Hibbert, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)

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