Last reviewed · How we verify
NCT05404204: ROTA-PACE
The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy
trial in Coronary Artery Disease in 100 participants. Status unknown.
1 July 2022
Quick facts
| Lead sponsor | Vancouver Island Health Authority |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 February 2021 |
| Primary completion | 1 July 2022 |
| Estimated completion | 1 July 2022 |
| Sites | 1 location across Canada |
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Coronary Artery Calcification — all drugs for Coronary Artery Calcification →
- Bradycardia — all drugs for Bradycardia →
Sponsor
Vancouver Island Health Authority — full company profile →
Who can join
Adults 18 to 90, any sex, with Coronary Artery Disease or Coronary Artery Calcification. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05404204
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05404204 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vancouver Island Health Authority
- Last refreshed: 3 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05404204.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing