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Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions (STOP CLOT)

Primary Purpose

Mitral Regurgitation, Atrial Fibrillation, Anticoagulation

Status

Enrolling by invitation

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

early anticoagulation

late anticoagulation

About this trial

This is an interventional treatment trial for Mitral Regurgitation

Eligibility Criteria

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

Inclusion Criteria:

Age above 18 years
Planned TEER procedure or left atrial appendage closure
The patient is willing to sign informed consent and comply will all study procedure

Exclusion Criteria:

Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization.
Congenital or acquire bleeding disorders (i.e.diagnosed thrombophilia, bleeding diathesis, thrombocyopenia with platelet count <50 thousand/ml, INR elevated >1.5 in the last test prior to randomization)
INR > 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists. (applies to the last INR value prior to randomization)
Last dose of new oral anticoagulant < 48 hours prior to the procedure (assessed at randomization)
Last dose of low molecular weight heparin <12 hours prior to the procedure (assessed at randomization)
Contraindications to MR imaging (i.e. claustrophobia, ferromagnetic intraocular foreign boddies, ferromagnetic metalic prostheses)
Implanted cardiac devices for electrotherapy if:
- device has epicardial leads
- left disconnected leads or non-functional or damaged devices
- device implanted within abdominal wall
- the patient is pacemaker dependant (lack of escape rhytm >30/min)
- the device was implanted or exchanged within 6 weeks prior to the MR examination
- device mulfunction identified during the control performed prior to the MR examination, that in the opinion of electrophysiologist team may impact the safety of MR imaging
- low voltage of the device battery - the battery on the examination day should have at least 20% of the voltage value between the nominal value and elective replacement indicator (ERI) value, or the expected battery life calculated by the device should equal or exceed one year.

Sites / Locations

Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny
Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Uniwersytecki Szpital Kliniczny w Poznaniu
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early UFH administration

Late UFH administration

Arm Description

The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 5 minutes prior to the start of the TSP.

The iv. bolus of UFH (100Units/kg) will be given immediately after TSP, defined as the introduction of transseptal sheath into the left atrium.

Outcomes

Primary Outcome Measures

1. MACCE 2. Intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transsesophageal echocardiography 3. Occurrence of new ischemic lesions with diameter ≥4 mm in brain MR performed 2-5 days after procedure

Major adverse cardiac and cerebrovascular events (MACCE) will include: death, stroke, TIA, peripheral embolization, myocardial infarction within 30 days from the index procedure.

Secondary Outcome Measures

Moderate and severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization

Intraprocedural fresh thrombus formation in the right of left atrium as assessed with periprocedural transsesophageal echocardiography

Occurrence of new ischemic brain lesion in the MR examination performed within 2-5 days post index procedure.

Major adverse cardiac and cerebrovascular events (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index procedure.

Full Information

NCT ID

NCT05305612

First Posted

March 14, 2022

Last Updated

July 10, 2023

Sponsor

National Institute of Cardiology, Warsaw, Poland

Collaborators

Medical Research Agency, Poland, CRO Soft Communication

1. Study Identification

Unique Protocol Identification Number

NCT05305612

Brief Title

Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Acronym

STOP CLOT

Official Title

Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

March 13, 2022 (Actual)

Primary Completion Date

May 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Cardiology, Warsaw, Poland

Collaborators

Medical Research Agency, Poland, CRO Soft Communication

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The transcatheter edge to edge mitral valve repair (TEER) and left atrial appendage closure (LAAC) are the interventional cardiology procedures that require periprocedural anticoagulation with unfractionated heparin (UFH). The UFH is administered either before or immediately after transseptal puncture, at the discretion of the operator The aim of the study is to establish the optimal timing of initiation of periprocedural anticoagulation in patients undergoing structural heart interventions requiring transseptal puncture (TEER and LAAC), Patients who undergo TEER implantation or LAAC procedure will be randomized to two groups: Early UFH administration. The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 5 minutes prior to the start of the TSP. Late UFH administration. The iv. bolus of UFH (100Units/kg) will be given immediately after TSP, defined as the introduction of transseptal sheath into the left atrium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Regurgitation, Atrial Fibrillation, Anticoagulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized to: Early unfractionated heparin administration. The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 5 minutes prior to the start of the TSP. Late unfractionated heparin administration. The iv. bolus of UFH (100Units/kg) will be given immediately after TSP, defined as the introduction of transseptal sheath into the left atrium.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The study will be conducted by blinded and unblinded staff. The participants, investigators, care provider and outcome assessors will be blinded. However, in every center the dedicated unblinded study nurse will randomize the patient and prepare two syringes either with saline or UFH. The syringes will be labeled with number 1 and number 2 and will be provided to the anestesiologist taking care of patient during the procedure. The injection from syringe nr 1 will be administered after obtaining the venous access and 5 minutes before the start of TSP. The injection from syringe nr 2 will be administered after TSP defined as introduction of trans-septal sheath into the left atrium. The unblinding nurse responsible for the randomization procedure and preparation of syringe nr 1 and syringe nr 2 and will be not involved in any other procedures or care of the patients enrolled into the study.

Allocation

Randomized

Enrollment

410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early UFH administration

Arm Type

Experimental

Arm Description

The iv. bolus of UFH (100Units/kg) will be given after obtained femoral vein access and at least 5 minutes prior to the start of the TSP.

Arm Title

Late UFH administration

Arm Type

Active Comparator

Arm Description

The iv. bolus of UFH (100Units/kg) will be given immediately after TSP, defined as the introduction of transseptal sheath into the left atrium.

Intervention Type

Other

Intervention Name(s)

early anticoagulation

Intervention Description

Anticoagulation prior to transseptal puncture

Intervention Type

Other

Intervention Name(s)

late anticoagulation

Intervention Description

Anticoagulation after transseptal puncture

Primary Outcome Measure Information:

Title

Description

Major adverse cardiac and cerebrovascular events (MACCE) will include: death, stroke, TIA, peripheral embolization, myocardial infarction within 30 days from the index procedure.

Time Frame

Within 30 days from the index procedure

Secondary Outcome Measure Information:

Title

Moderate and severe bleeding complications (BARC 2-5) including cardiac tamponade requiring intervention during the index hospitalization

Time Frame

during the hospitalization related to the index procedure but up to 30 days from randomization

Title

Intraprocedural fresh thrombus formation in the right of left atrium as assessed with periprocedural transsesophageal echocardiography

Time Frame

during index procedure

Title

Occurrence of new ischemic brain lesion in the MR examination performed within 2-5 days post index procedure.

Time Frame

within 2-5 days post index procedure

Title

Major adverse cardiac and cerebrovascular events (death, stroke, TIA, peripheral embolization, myocardial infarction) within 30 days from the index procedure.

Time Frame

within 30 days from index procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age above 18 years Planned TEER procedure or left atrial appendage closure The patient is willing to sign informed consent and comply will all study procedure Exclusion Criteria: Women who are pregnant or breastfeeding and those women of childbearing potential who do not agree to use at least two contraceptive measures (oral contraception, mechanical contraception, approved contraceptive implants, intrauterine device, tubal ligation). The criterion does not apply to women who have been postmenopausal for at least 2 years prior to study enrollment (defined as at least one year without menstrual periods) or underwent surgical sterilization procedure. All eligible women who are younger than 55 years must have negative pregnancy test within 24 hours prior to randomization. Congenital or acquire bleeding disorders (i.e.diagnosed thrombophilia, bleeding diathesis, thrombocyopenia with platelet count <50 thousand/ml, INR elevated >1.5 in the last test prior to randomization) INR > 1.5 within 24 hours prior to the procedure in patients chronically treated with vitamin K antagonists. (applies to the last INR value prior to randomization) Last dose of new oral anticoagulant < 48 hours prior to the procedure (assessed at randomization) Last dose of low molecular weight heparin <12 hours prior to the procedure (assessed at randomization) Contraindications to MR imaging (i.e. claustrophobia, ferromagnetic intraocular foreign boddies, ferromagnetic metalic prostheses) Implanted cardiac devices for electrotherapy if: device has epicardial leads left disconnected leads or non-functional or damaged devices device implanted within abdominal wall the patient is pacemaker dependant (lack of escape rhytm >30/min) the device was implanted or exchanged within 6 weeks prior to the MR examination device mulfunction identified during the control performed prior to the MR examination, that in the opinion of electrophysiologist team may impact the safety of MR imaging low voltage of the device battery - the battery on the examination day should have at least 20% of the voltage value between the nominal value and elective replacement indicator (ERI) value, or the expected battery life calculated by the device should equal or exceed one year.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerzy Pręgowski, MD, PhD

Organizational Affiliation

National Institute of Cardiology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Uniwersyteckie Centrum Kliniczne Gdański Uniwersytet Medyczny

City

Gdańsk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Górnośląskie Centrum Medyczne im. Leszka Gieca Śląskiego Uniwersytetu Medycznego

City

Katowice

Country

Poland

Facility Name

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

City

Lublin

Country

Poland

Facility Name

Uniwersytecki Szpital Kliniczny w Poznaniu

City

Poznań

ZIP/Postal Code

60-355

Country

Poland

Facility Name

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

City

Warszawa

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

to be defined

IPD Sharing Time Frame

IPD sharing will be considered after study completion and publication of the results.

IPD Sharing Access Criteria

to be defined

Learn more about this trial

Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions

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