The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy

• Conditions: Coronary Artery Disease; Bradycardia; Coronary Artery Calcification

• Registration Number: NCT05404204
• Lead Sponsor: Vancouver Island Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-05-31
• Last Update Submitted: 2022-05-31
• Study First Posted: 2022-06-03
• Last Update Posted: 2022-06-03
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• Pre-existing pacemaker or implantable cardioverter defibrillator.
• Mobitz II heart block or complete heart block.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Royal Jubilee Hospital; 🇨🇦 Victoria, British Columbia, Canada