Shock Efficacy Study Comparing Fixed Tilt and Fixed Pulse Width in a General Implantable-Cardioverter Population

Not Applicable

Completed

• Conditions: Ventricular Arrythmia
• Interventions: Device: Fixed Tilt (65%); Device: Fixed Pulse Width

• Registration Number: NCT03632057
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-06-06
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-08-10
• Study First Posted: 2018-08-15
• Primary Completion: 2025-04-18
• Study Completion: 2025-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 779

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Tilt (65%)	Fixed Tilt (65%)	This is the control group, so device programming for shock energy is the default setting
Fixed Pulse Width	Fixed Pulse Width	This is the Study group.

Primary Outcome Measures

Name	Time	Method
Efficacy of the first appropriate shock to revert a tachyarrhythmia to sinus rhythm	5 years	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).

Trial Locations

Locations (2)

Hospital Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Virgen de la Victoria; 🇪🇸 Malaga, Andalucia, Spain