Coronary Artery DiseaseROTA-PACENCT05404204
The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy
An observational study of Coronary Artery Disease and Coronary Artery Calcification, run by Vancouver Island Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Calcification, Bradycardia
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients undergoing rotational atherectomy for calcific coronary disease without any exclusion criteria
Who may be able to join
- Age 18-90 years
- Undergoing percutaneous coronary intervention for angina or acute coronary syndrome.
- Calcific coronary disease requiring rotational atherectomy
Who cannot join
- Pre-existing pacemaker or implantable cardioverter defibrillator.
- Mobitz II heart block or complete heart block.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
Bilal Iqbal, MD PhD FRCPC, 2505953111, bilal.iqbal@viha.ca
About this study
Official title: 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.
- Keywords
- Coronary Artery Calcification, Rotational Atherectomy, Temporary Pacemaker
- Medical subject headings
- Coronary Artery Disease, Bradycardia
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful ventricular pacing
Ability to obtain successful ventricular capture prior to rotational atherectomy
Measured: At the start of the PCI procedure immediately prior to rotational atherectomy
Ventricular pacing threshold
The pacing threshold to obtain successful ventricular capture
Measured: 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
Measured: At the end of the PCI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Feb 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vancouver Island Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Iqbal, Vancouver Island Health Authority
- Investigators
- Bilal Iqbal, MD PhD FRCPC, Principal investigator, Royal Jubilee Hospital, Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404204
- Sponsor's protocol ID
- ROTA-PACE
- Acronym
- ROTA-PACE
- Status last verified
- May 2022
- First submitted
- 26 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37409992
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy to ROTAblate and PACE (ROTA-PACE) Study
- ClinicalTrials.gov ID
- NCT05404204
- Acronym / sponsor ID
- ROTA-PACE / ROTA-PACE
- Keywords
- Coronary Artery Calcification, Rotational Atherectomy, Temporary Pacemaker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vancouver Island Health AuthorityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing rotational atherectomy for calcific coronary disease without any exclusion criteria
Key inclusion criteria (3 listed)
- Age 18-90 years
- Undergoing percutaneous coronary intervention for angina or acute coronary syndrome.
- Calcific coronary disease requiring rotational atherectomy
Key exclusion criteria (2 listed)
- Pre-existing pacemaker or implantable cardioverter defibrillator.
- Mobitz II heart block or complete heart block.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
Complications
Time frame: At the end of the PCI procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Derived from this study: PubMed 37409992Iqbal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilal Iqbal, MD PhD FRCPC principal investigator
Royal Jubilee Hospital, Victoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Artery Calcification, run by Vancouver Island Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bilal Iqbal, MD PhD FRCPC (2505953111, bilal.iqbal@viha.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful ventricular pacing (time frame: At the start of the PCI procedure immediately prior to rotational atherectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.