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

NCT05404204 | Unknown

• 1 other identifier: ROTA-PACE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Coronary Artery Calcification; Rotational Atherectomy; Temporary Pacemaker

Outcome Measures

Primary Outcomes (2)

• 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

• Ventricular pacing threshold

  The pacing threshold to obtain successful ventricular capture

  At the start of the PCI procedure immediately prior to rotational atherectomy

Secondary Outcomes (1)

• Complications

  At the end of the PCI procedure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vancouver Island Health Authority: lead

Study Sites (1)

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

RECRUITING

Related Publications (1)

• Iqbal MB, Robinson SD, Nadra IJ, Das D, van Zyl M, Sikkel MB, Della Siega A. The Efficacy and Safety of an Adjunctive Transcoronary Pacing Strategy During Rotational Atherectomy: ROTA-PACE Study. JACC Cardiovasc Interv. 2023 Sep 11;16(17):2189-2190. doi: 10.1016/j.jcin.2023.05.022. Epub 2023 Jul 5. No abstract available.

  PMID: 37409992 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Bradycardia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bilal Iqbal, MD PhD FRCPC

  Royal Jubilee Hospital, Victoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilal Iqbal, MD PhD FRCPC

CONTACT

2505953111; bilal.iqbal@viha.ca

Anthony Della Siega, MD FRCPC

CONTACT

2505953111; anthony.dellasiega@viha.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 3, 2022
• Study Start: February 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

CA (1)