Recruiting

Pacing Strategy

Sponsor:

Vancouver Island Health Authority

Code:

NCT05404204

Conditions

Coronary Artery Disease

Coronary Artery Calcification

Bradycardia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Coronary Artery Disease

Coronary Artery Calcification

Bradycardia

Study ID

NCT05404204

Start date

Feb 1, 2021

Status verified date

May, 2022

Completion date

Jul 1, 2022

Anticipated

Primary completion date

Jul 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Successful ventricular pacing [ Time Frame: At the start of the PCI procedure immediately prior to rotational atherectomy ]
  • Ventricular pacing threshold [ Time Frame: At the start of the PCI procedure immediately prior to rotational atherectomy ]

Central Contacts and Locations

Central contacts

Bilal Iqbal, MD PhD FRCPC

2505953111bilal.iqbal@viha.ca

Anthony Della Siega, MD FRCPC

2505953111anthony.dellasiega@viha.ca

Locations

Royal Jubilee Hospital

Recruiting

Victoria, British Columbia, Canada, V8R 1J8

Contacts

Bilal Iqbal, MD PhD FRCPC

2505953111bilal.iqbal@viha.ca

More Information

Sponsor

Vancouver Island Health Authority

Last update posted

Jun 3, 2022

Last verified

May, 2022

Keywords

  • Coronary Artery Calcification
  • Rotational Atherectomy
  • Temporary Pacemaker

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vancouver Island Health Authority on 2022-06-03.