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

Strategy to ROTAblate and PACE (ROTA-PACE) Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05404204

Acronym

ROTA-PACE

Enrollment

100

Registered

2022-06-03

Start date

2021-02-01

Completion date

2022-07-01

Last updated

2022-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Coronary Artery Calcification, Coronary Artery Disease

Keywords

Coronary Artery Calcification, Rotational Atherectomy, Temporary Pacemaker

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Ventricular pacing threshold	At the start of the PCI procedure immediately prior to rotational atherectomy	The pacing threshold to obtain successful ventricular capture
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

Secondary

Measure	Time frame	Description
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

Countries

Canada

Contacts

Primary ContactBilal Iqbal, MD PhD FRCPC

bilal.iqbal@viha.ca2505953111

Backup ContactAnthony Della Siega, MD FRCPC

anthony.dellasiega@viha.ca2505953111

Outcome results