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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03632057
Other study ID # CRD_914
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 6, 2018
Est. completion date May 2025

Study information

Verified date April 2020
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, 1:1 randomized, interventional, multicenter and international trial. Approximately 790 subjects are expected to be enrolled to 40 sites in the south of Europe and Middle East.

The objective of this study is to evaluate and compare the efficacy of the first appropriate shock of an ICD in a ventricular tachyarrhythmia, when the waveform of the shock is programmed with the standard waveform, Fixed Tilt with a value of 65% (Control Group), versus the exclusive waveform programmable in SJM ICDs, Fixed Pulse Width (Study Group), in a standard population of subjects with ICD indication.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 790
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects who meet the current ESC indications for ICD or CRT-D implant. This includes upgrades indications from pacemaker to ICD or to CRT-D or replacements of ICDs or CRT-Ds provided that there is no previous record of ineffective shocks

- Subjects who are willing to be registered on the Merlin.net remote follow-up program

- Subject =18 years

- Subjects with life expectancy of at least 1 year

- Subjects who agree to comply with the follow-up program included in this protocol

Exclusion Criteria:

- • Subjects on the waiting list for a heart transplant or under consideration for a transplant over the next 12 months

- Subjects with Myocardial infarction or unstable angina within 40 days prior to enrollment

- Subjects who have undergone a recent cardiac revascularization (PTCA, Stent or CABG) procedure in the 4 weeks prior to enrollment

- Functional NYHA Class IV

- Subjects who are participating in another ICD or CRT-D study

- Subjects who are pregnant at the time of enrollment or women of childbearing potential that do not take contraceptives

- Any disability or limitations to correctly understand or complete the study (physical, intellectual, logistical)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Fixed Tilt (65%)
This is the standard group, so device programming for shock energy is the default setting
Fixed Pulse Width
The device has to be programmed with fixed pulse width for each phase of the biphasic waveform

Locations

Country Name City State
Spain Hospital Puerta de Hierro Madrid
Spain Hospital Virgen de la Victoria Malaga Andalucia

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm Rate of rhythm conversion from Ventricular Tachyarrhythmia to sinus rhythm by the first appropriate shock programmed to 25 Joules (or equivalent voltage) programming the shock waveform in Fixed Pulse Width (Study Group) versus the Fixed Tilt with value 65% (Control Group). 5 years
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