Assessment of Risk Factors for Appropriate ICD (Implantable Cardioverter-defibrillator) Intervention in Patients With Ischemic Cardiomyopathy

NCT04014946 | Completed

• 1 other identifier: TA97
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Design: PARCADIA is a prospective non-randomized non-interventional multi-center clinical investigation in Europe. Patients with depressed LV (left ventricular) function assessed on local standards, of ischemic origin and on chronic optimal medical therapy will be selected according to inclusion and exclusion criteria, implanted with an ICD after executing baseline investigations and prospectively followed up for minimal 24 months and until the termination of the clinical investigation. General objective: analysis of baseline risk factors to identify predictors for appropriate ICD intervention in patients with ischemic cardiomyopathy receiving an ICD for primary prevention (MADIT II population). Hypothesis: The primary alternative hypothesis states that the mean relative infarct transmurality (RIT) is different in patients with (RITshock or ATP (Anti Tachy Pacing)) and without (RITno shock or ATP )appropriate ICD intervention, i.e. shock or ATP.

• Null hypothesis (H0): RITshock or ATP = RITno shock or ATP
• Alternative hypothesis (Ha): RITshock or ATP ≠ RITno shock or ATP Sample size: 200 patients. Follow-up: Enrolment visit, pre implant screening, ICD implantation, pre-hospital discharge visit, and follow-up (FUP) visits at 2, 6, 12, 18, 24 months including home monitoring. Additional routine FUP every 6 months until study termination after last enrolled patient has completed 2 years FUP.

Conditions

ICD; Cardiomyopathy Ischemic; Primary Prevention

Outcome Measures

Primary Outcomes (2)

• Relative Infarct Transmurality

  Percentage Relative Infarct Transmurality (RIT = transmural infarct mass / total infarct mass) obtained from LGE-CMR

  Measured during Late gadolinium enhancement cardiovascular magnetic resonance (LGE-CMR) imaging within 3 months after inclusion and before ICD implantation

• appropriate ICD intervention (shock or ATP)

  assessment whether patient had appropriate ICD intervention (shock or ATP) or not during 24 months follow-up. ICD interventions will be labeled appropriate or non-appropriate by an independent endpoint committee.

  Until the 24 month follow-up

Secondary Outcomes (23)

• LV function (EF)

  Baseline

• LV mass

  Baseline

• total infarct mass

  Baseline

• transmural infarct mass

  Baseline

• mean Heart Rate (HR)

  Baseline

Study Arms (1)

ICD implantation

OTHER

Implantation of a Lumax 540 single/dual chamber ICD or successor according to local practice within 3 months after enrolment. The patient will be implanted with a single or dual chamber device according to ESC guidelines.

Device: ICD implantation

Interventions

ICD implantation DEVICE

implantation of the Lumax 540 single/dual chamber ICD or successor

Also known as: Lumax 540 single/dual chamber ICD or successor

ICD implantation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with ischemic cardiomyopathy indicated for a de novo ICD implantation for primary prevention, according to ESC guidelines or local standards (MADIT II population)
• Written informed consent / willingness and ability to comply with the protocol

You may not qualify if:

• Contraindication for MRI
• Severe renal dysfunction (stage 4 or 5) resulting in contra-indication for the admission of gadolinium during MRI (See Appendix A for more details)
• Indication for secondary prevention ICD implantation
• Class I indication for cardiac resynchronization therapy
• Heart failure with New York Heart Association functional class IV
• LV ejection fraction \>40%
• Age \<18 years and \>85 years
• Women that are pregnant, lactating or planning to become pregnant
• Participating in any other clinical trial with active intervention(s) during the course of this study
• Life expectancy less than 1 year

Sponsors & Collaborators

• Biotronik SE & Co. KG: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study model is single group. At the analysis the patients will be divided in two groups bij outcome of ICD therapy/no ICD therapy. The endpoints related to the primary hypothesis are appropriate ICD intervention (shock or ATP) and Relative Infarct Transmurality (RIT = transmural infarct mass / total infarct mass) obtained from LGE-CMR. ICD interventions will be labeled appropriate or non-appropriate by an independent endpoint committee. * RITshock or ATP: RIT expectation value in patients with ≥1 appropriate shock or ATP therapy until the 24mo follow-up * RIT no shock or ATP: RIT expectation value in patients without any appropriate shock or ATP therapy until the 24mo follow-up

Study Record Dates

• First Submitted: May 10, 2019
• First Posted: July 10, 2019
• Study Start: July 24, 2012
• Primary Completion: May 28, 2020
• Study Completion: July 22, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share