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Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP) (REVRAMP)

Primary Purpose

Arrythmia

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Induced pacing of the heart
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrythmia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who are due to have a new defibrillator (including cardiac resynchronisation defibrillator) implant or box change

Exclusion Criteria:

  • 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.

Sites / Locations

  • Leeds Teaching Hospitals NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti tachycardia pacing

Arm Description

Outcomes

Primary Outcome Measures

Termination/cessation of ventricular tachycardia by rev ramp pacing protocol

Secondary Outcome Measures

Full Information

First Posted
January 19, 2018
Last Updated
February 18, 2020
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03412240
Brief Title
Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)
Acronym
REVRAMP
Official Title
Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
March 10, 2020 (Anticipated)
Study Completion Date
March 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti tachycardia pacing
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Induced pacing of the heart
Intervention Description
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.
Primary Outcome Measure Information:
Title
Termination/cessation of ventricular tachycardia by rev ramp pacing protocol
Time Frame
10 mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who are due to have a new defibrillator (including cardiac resynchronisation defibrillator) implant or box change Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muzahir Tayebjee, MBChB (Hons) MD MRCP
Phone
+441133926619
Email
muzahir.tayebjee@nhs.net
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muzahir Tayebjee, MBChB (Hons) MD MRCP

12. IPD Sharing Statement

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Reverse RAMP Pacing to Terminate Ventricular Tachycardia ( REV-RAMP)

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