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

Coronary Artery Disease Clinical Trial

— ROTA-PACE  

Official title:

Strategy to ROTAblate and PACE (ROTA-PACE) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05404204
• Other study ID #: ROTA-PACE
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2022
• Source: Vancouver Island Health Authority
• Contact: Bilal Iqbal, MD PhD FRCPC
• Phone: 2505953111
• Email: bilal.iqbal[@]viha.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia
• Calcinosis
• Coronary Artery Calcification
• Coronary Artery Disease

Locations

Country	Name	City	State
Canada	Royal Jubilee Hospital	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Vancouver Island Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful ventricular pacing	Ability to obtain successful ventricular capture prior to rotational atherectomy	At the start of the PCI procedure immediately prior to rotational atherectomy
Primary	Ventricular pacing threshold	The pacing threshold to obtain successful ventricular capture	At the start of the PCI procedure immediately prior to rotational atherectomy
Secondary	Complications	(a) Coronary wire-related intractable spasm (unresponsive to vasodilator therapy); (b) coronary wire-related perforation; (c) New atrial or ventricular arrhythmia	At the end of the PCI procedure