Model 20105 Lead Study

Model 20105 Lead Study - Model 20105 Lead Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42225

Enrollment

Registered

2015-04-01

Start date

2015-04-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus node dysfunction

Interventions

At baseline- ECG Implant - holter/ venogram PH - Echocardiogram/ ECG 1 mnd - geen extra handeling 3 mnd - holter 6 mnd - Echocardiogram

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient has a cardiac pacing indication for sinus node dysfunction (dual chamber pacemaker)

Exclusion criteria

Exclusion criteria: Patient is indicated for biventricular pacemaker or ICD Patient is pacing dependent Patient has a previous Pacemaker System Patient has known coronary venous vasculature that is inadequate for lead placement Patient has unstable angina pectoris or has had an acute myocardial infarction (MI) within the last month Patient has had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within the past three months Patient is not in sinus rhythm at implant Patient is unable to tolerate an urgent thoracotomy

Design outcomes

Primary

Measure	Time frame
To evaluate the implant procedure related and lead related complications of the Model 20105 single pass lead during the first month of follow up.	—

Secondary

Measure	Time frame
1.The following rates will be evaluated: - Medtronic Model 20105 lead implant success - Medtronic Model 20105 fixation attempts 2.The following implant related times for patients with successful Model 20105 lead implants will be evaluated: - Total implant - Fluoroscopy - Cannulation - Model 20105 single pass lead placement time 3. All AEs (excluding unavoidable AEs * refer to Table 4) will be evaluated 4. The following electrical data will be collected at implant and scheduled follow-ups and analyzed: - A and V voltage threshold(s) at 0.5 ms pulse width - P and R-wave amplitude - A and V impedance (implant only) - Phrenic nerve stimulation threshold (implant only) 5. The Model 20105 lead implant handling characteristics such as pushability, ease of positioning, traceability, location of lead fixation, and ease of helix fixation assessed through physician feedback will be evaluated. Feedback from the investigators regarding the successful placement of the lead at a location giving adequate electrical performance will be evaluated.	—

Measure

Time frame

1.The following rates will be evaluated: - Medtronic Model 20105 lead implant success - Medtronic Model 20105 fixation attempts 2.The following implant related times for patients with successful Model 20105 lead implants will be evaluated: - Total implant - Fluoroscopy - Cannulation - Model 20105 single pass lead placement time 3. All AEs (excluding unavoidable AEs * refer to Table 4) will be evaluated 4. The following electrical data will be collected at implant and scheduled follow-ups and analyzed: - A and V voltage threshold(s) at 0.5 ms pulse width - P and R-wave amplitude - A and V impedance (implant only) - Phrenic nerve stimulation threshold (implant only) 5. The Model 20105 lead implant handling characteristics such as pushability, ease of positioning, traceability, location of lead fixation, and ease of helix fixation assessed through physician feedback will be evaluated. Feedback from the investigators regarding the successful placement of the lead at a location giving adequate electrical performance will be evaluated.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)