CClinicalTrials.gg
Status unknownNCT05404204ROTA-PACEUpdated Jun 3, 2022

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

An observational study in Coronary Artery Disease, Coronary Artery Calcification and Bradycardia, sponsored by Vancouver Island Health Authority. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-06-03.

Sponsored by Vancouver Island Health Authority · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease
  • Coronary Artery Calcification
  • Bradycardia

Keywords

  • Coronary Artery Calcification
  • Rotational Atherectomy
  • Temporary Pacemaker
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 100 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Vancouver Island Health Authority is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients undergoing rotational atherectomy for calcific coronary disease without any exclusion criteria

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pre-existing pacemaker or implantable cardioverter defibrillator.
  • Mobitz II heart block or complete heart block.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Successful ventricular pacing

    Ability to obtain successful ventricular capture prior to rotational atherectomy

    Time frame: At the start of the PCI procedure immediately prior to rotational atherectomy

  2. Ventricular pacing threshold

    The pacing threshold to obtain successful ventricular capture

    Time frame: At the start of the PCI procedure immediately prior to rotational atherectomy

Secondary outcomes

  1. Complications

    (a) Coronary wire-related intractable spasm (unresponsive to vasodilator therapy); (b) coronary wire-related perforation; (c) New atrial or ventricular arrhythmia

    Time frame: At the end of the PCI procedure

07

Study locations

1 of 1 sites recruiting
  • Royal Jubilee Hospital
    Victoria, British Columbia V8R 1J8, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05404204
Lead sponsor
Vancouver Island Health Authority
Responsible party
Bilal Iqbal (Doctor, Vancouver Island Health Authority) — Principal investigator
First posted
Jun 3, 2022
Start date
Feb 1, 2021
Primary completion
Jul 1, 2022 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Jun 3, 2022

Study contacts

Bilal Iqbal, MD PhD FRCPC
Contact
bilal.iqbal@viha.ca
2505953111
Anthony Della Siega, MD FRCPC
Contact
anthony.dellasiega@viha.ca
2505953111
Bilal Iqbal, MD PhD FRCPC
principal investigator · Royal Jubilee Hospital, Victoria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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