- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05404204
The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy (ROTA-PACE)
May 31, 2022 updated by: Bilal Iqbal, Vancouver Island Health Authority
Strategy to ROTAblate and PACE (ROTA-PACE) Study
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.
Study Overview
Status
Recruiting
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bilal Iqbal, MD PhD FRCPC
- Phone Number: 2505953111
- Email: bilal.iqbal@viha.ca
Study Contact Backup
- Name: Anthony Della Siega, MD FRCPC
- Phone Number: 2505953111
- Email: anthony.dellasiega@viha.ca
Study Locations
-
-
British Columbia
-
Victoria, British Columbia, Canada, V8R 1J8
- Recruiting
- Royal Jubilee Hospital
-
Contact:
- Bilal Iqbal, MD PhD FRCPC
- Phone Number: 2505953111
- Email: bilal.iqbal@viha.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing rotational atherectomy for calcific coronary disease without any exclusion criteria
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful ventricular pacing
Time Frame: At the start of the PCI procedure immediately prior to rotational atherectomy
|
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
Time Frame: At the start of the PCI procedure immediately prior to rotational atherectomy
|
The pacing threshold to obtain successful ventricular capture
|
At the start of the PCI procedure immediately prior to rotational atherectomy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications
Time Frame: 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
|
At the end of the PCI procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bilal Iqbal, MD PhD FRCPC, Royal Jubilee Hospital, Victoria
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
May 26, 2022
First Submitted That Met QC Criteria
May 31, 2022
First Posted (Actual)
June 3, 2022
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROTA-PACE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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