ROTA-PACE: The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy

Sponsor

Vancouver Island Health Authority (Other)

Overall Status

Recruiting

CT.gov ID

NCT05404204

Collaborator

(none)

100

Enrollment

Location

16.9

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. Cardiologists can treat these narrowings with balloons and stents. However, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. Rotational atherectomy is a tool to treat calcific coronary disease. It uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. However, during this procedure patients can experience a slow heart rate which may compromise procedural safety. Cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. This maintains a safe heart rate throughout the procedure. However, inserting the temporary pacemaker is associated with additional complications. We have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Artery Calcification Bradycardia

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Strategy to ROTAblate and PACE (ROTA-PACE) Study

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

Successful ventricular pacing [At the start of the PCI procedure immediately prior to rotational atherectomy]
Ability to obtain successful ventricular capture prior to rotational atherectomy
Ventricular pacing threshold [At the start of the PCI procedure immediately prior to rotational atherectomy]
The pacing threshold to obtain successful ventricular capture

Secondary Outcome Measures

Complications [At the end of the PCI procedure]
(a) Coronary wire-related intractable spasm (unresponsive to vasodilator therapy); (b) coronary wire-related perforation; (c) New atrial or ventricular arrhythmia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Age 18-90 years
Undergoing percutaneous coronary intervention for angina or acute coronary syndrome.
Calcific coronary disease requiring rotational atherectomy