Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D

Completed

Conditions: Heart failure
10019280

Registration Number: NL-OMON43949

Lead Sponsor: Sorin Group Nederland N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Patient with a class I and IIa indication for implantation of a CRT-D device according to current available guidelines
- Moderate/severe HF (NYHA class III or ambulatory IV)
- LVEF <= 35%
- LBBB: QRS >= 120 ms; non-LBBB: QRS >= 150 ms
- On stable, optimal durg regimen
- Patient is in sinus rhythm
- Signed and dated informed consent

Exclusion Criteria

- Ventricular tachyarrhythmia of transient or reversible causes
- Incessant ventricular tachyarrhythmia;
- Unstable angina, or acute MI, CABG, or PTCA within the past 4 weeks
- Correctable valvular disease that is the primary cause of heart failure
- Recent CVA or TIA (< 3 months)
- Persistent or permanent atrial arrhythmias
- Post heart transplant
- Renal failure (GFR<15 ml/min/1.73m2) or on dialysis
- Previous implant with a CRT/CRT-D device
- Concurrent implant with another pacemaker or ICD
- Already included in another clinical study that could confound the results of this study
- Life expectancy less than 1 year;
- Inability to understand the purpose of the study or to understand and complete the QOL questionnaire
- Unavailability for scheduled follow-up or refusal to cooperate
- Sensitivity to 1 mg DSP
- Age of less than 18 years
- Pregnancy
- Drug addiction or abuse
- Under guardianship

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint: the proportion of responders at the 12-month follow-up<br /><br>visit. For the primary effectiveness endpoint, the investigational and control<br /><br>groups will be compared in a non-inferiority context employing a clinically<br /><br>meaningful difference of 10%. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>This secondary endpoint: de proportion of SonRtip lead-related<br /><br>complication-free rate, defined as the proportion of patients not experiencing<br /><br>any complication related to the SonRtip lead, relative to the total number of<br /><br>patients implanted with the lead. </p><br>