Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)
REVRAMP
1 other identifier
interventional
25
1 country
1
Brief Summary
Cardiac pacing which involved stimulating the heart electrically with electrical wires that go into the heart is routine practice in the diagnosis and treatment of heart rhythm problems. Clinically this involved the fields of cardiac pacing and electrophysiology. Patients who are at risk of sudden death because of serious heart rhythms that are a result of malfunction of the electrical system of the pumping chambers of the heart (ventricles) are generally implanted with specialised pacemakers that can defibrillate (shock) the heart if a nasty life threatening rhythm should result. Shocks are painful and in order to try and treat these rhythms without shocks, anti tachycardia pacing is performed (this is routine part of the device), which aims to interrupt the rhythm by stimulating the heart electrically. This does not always work and can destabilise the rhythm leading to a shock. REVRAMP is a novel modification of anti tachycardia pacing which involved stimulating the heart through the defibrillator wires in a different way. It appears to work better and seems less likely to destabilise the heart rhythm, hence can reduce painful shocks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2017
CompletedFirst Submitted
Initial submission to the registry
January 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2020
CompletedFebruary 19, 2020
February 1, 2020
2.2 years
January 19, 2018
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Termination/cessation of ventricular tachycardia by rev ramp pacing protocol
10 mins
Study Arms (1)
Anti tachycardia pacing
EXPERIMENTALInterventions
Once the defibrillator leads have been inserted or, in the case of a box change, the old leads have been tested as per routine procedure, these pacing leads will be connected to an external pacing stimulator. The test involves electrically pacing your heart at different rates and we will be constantly monitoring you under close clinical supervision. During the test, your heart will be electrically stimulated to beat at a faster rate.
Eligibility Criteria
You may qualify if:
- Participants who are due to have a new defibrillator (including cardiac resynchronisation defibrillator) implant or box change
You may not qualify if:
- Contraindications to defibrillator testing e.g. severe untreatable coronary disease Intracardiac thrombus Interruption of anticoagulation Participants undergoing box change, device upgrade or revision Inability or unwillingness to provide informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2018
First Posted
January 26, 2018
Study Start
December 14, 2017
Primary Completion
March 10, 2020
Study Completion
March 10, 2020
Last Updated
February 19, 2020
Record last verified: 2020-02