Trial Outcomes & Findings for Electronic Repositioning With Acuity and Easytrak Leads (NCT NCT00610116)
NCT ID: NCT00610116
Last Updated: 2021-04-21
Results Overview
The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
305 participants
Primary outcome timeframe
From implant until first follow up (occurred between 3 or 6 month after implant procedure)
Results posted on
2021-04-21
Participant Flow
Participant milestones
| Measure |
LV Lead Electronically Repositioning
Single arm study: Electronic Repositioning: Change of pacing vectors for cardiac resynchronization therapy pacing
|
|---|---|
|
Overall Study
STARTED
|
305
|
|
Overall Study
COMPLETED
|
292
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
LV Lead Electronically Repositioning
n=292 Participants
Single arm study
Electronic Repositioning: Change of pacing vectors for Cardiac Resynchronization Therapy pacing
|
|---|---|
|
Age, Continuous
|
65.5 Years
STANDARD_DEVIATION 9.2 • n=292 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=292 Participants
|
|
Sex: Female, Male
Male
|
240 Participants
n=292 Participants
|
PRIMARY outcome
Timeframe: From implant until first follow up (occurred between 3 or 6 month after implant procedure)The primary endpoint was the percentage of patients in whom PNS induced by Left Ventricular (LV) pacing could be avoided by electronic repositioning from implantation to first regular follow up (3-6 months postimplant). In this evaluation, prevention of PNS was defined as PNS appearing with the standard pacing configuration-LV tip as cathode versus Right Ventricle (RV) coil as anode-and being avoided by at least one of the three alternative reprogrammable configurations.
Outcome measures
| Measure |
Inducible PNS @ Max Output 7V / 0.5 ms
n=292 Participants
Patients presenting PNS at implant and subsequent follow up (between 3 and 6 months after implant)
|
|---|---|
|
Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
Inducible PNS before Electronic Reprogramming
|
94 participants
|
|
Proportion of Patients Without the Occurrence of Cardiac Resynchronization Therapy (CRT)-Induced Phrenic Nerve Stimulation (PNS) Between Implant and First Regular Follow-up (FU)
Remaining PNS after Electronic Reprogramming
|
6 participants
|
Adverse Events
LV Lead Electronically Repositioning
Serious events: 40 serious events
Other events: 32 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
LV Lead Electronically Repositioning
n=292 participants at risk
Electronic Repositioning: Change of pacing vectors for CRT pacing
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
1.0%
3/292 • Number of events 3 • 6 months
|
|
Cardiac disorders
Multiple heart failure symptoms
|
3.4%
10/292 • Number of events 10 • 6 months
|
|
Cardiac disorders
Deep vein thrombosis (DVT)
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
General disorders
Death (no details)
|
1.7%
5/292 • Number of events 5 • 6 months
|
|
Surgical and medical procedures
Coronary Sinus Dissection
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disease
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Inappropriate pulse generator Shock
|
0.68%
2/292 • Number of events 2 • 6 months
|
|
Product Issues
Increase of Pacing Threshold
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Ineffective Pulse Generator Shock
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Inguinal Hernia
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Lead Dislodgment
|
1.4%
4/292 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Pocket hematoma
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Infections and infestations
Sepsis
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
General disorders
Syncope - Non cardiovascular
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Thoracic discomfort
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Lead Replacement - Unknown reason
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Cardiac disorders
Intervention for Coronary Artery Disease
|
0.68%
2/292 • Number of events 2 • 6 months
|
|
Cardiac disorders
Cardiac Arrhythmia
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Infections and infestations
Death - Sepsis
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Death - Hemorrhage
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Cardiac disorders
Death - Heart Failure
|
1.0%
3/292 • Number of events 3 • 6 months
|
Other adverse events
| Measure |
LV Lead Electronically Repositioning
n=292 participants at risk
Electronic Repositioning: Change of pacing vectors for CRT pacing
|
|---|---|
|
Product Issues
Elevated Defibrillation Threshold
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Elevated Pacing threshold
|
1.0%
3/292 • Number of events 3 • 6 months
|
|
Product Issues
Extracardiac stimulation
|
0.68%
2/292 • Number of events 2 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
1.0%
3/292 • Number of events 3 • 6 months
|
|
Cardiac disorders
Multiple heart failure symptoms
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Immune system disorders
Immunotheraphy
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Cardiac disorders
Atrial Arrhythmia
|
0.68%
2/292 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
General disorders
Bruising
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Cholecystomy
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Coronary sinus dissection
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Lead Dislodgment
|
1.7%
5/292 • Number of events 5 • 6 months
|
|
Product Issues
Pacing system infection
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Pocket Hematoma
|
1.7%
5/292 • Number of events 5 • 6 months
|
|
Infections and infestations
Sepsis
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Product Issues
Pulse Generator system issue
|
0.34%
1/292 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Lead - Procedure
|
1.0%
3/292 • Number of events 3 • 6 months
|
Additional Information
Joachim Winter, MD
Department of Cardiology and Rhythmology, Augusta Hospital, Duesseldorf, Germany.
Phone: +49 (0) 2118
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place