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NCT05404204: ROTA-PACE

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

Status unknown Last updated 3 June 2022
What this trial tests

trial in Coronary Artery Disease in 100 participants. Status unknown.

Timeline
1 February 2021
Primary endpoint
1 July 2022
1 July 2022

Quick facts

Lead sponsorVancouver Island Health Authority
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date1 February 2021
Primary completion1 July 2022
Estimated completion1 July 2022
Sites1 location across Canada

Conditions studied

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.

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Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

Other Vancouver Island Health Authority trials

Trials by the same sponsor.

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Data sources for this page

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