Trial Outcomes & Findings for ConsultaTM CRT-D Clinical Evaluation Study (NCT NCT00526162)
NCT ID: NCT00526162
Last Updated: 2025-07-02
Results Overview
Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
1 month
Results posted on
2025-07-02
Participant Flow
Participant milestones
| Measure |
Consulta Implant
Patients implanted with a Consulta device
|
|---|---|
|
Overall Study
STARTED
|
83
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Consulta Implant
Patients implanted with a Consulta device
|
|---|---|
|
Overall Study
Device not implanted
|
3
|
Baseline Characteristics
ConsultaTM CRT-D Clinical Evaluation Study
Baseline characteristics by cohort
| Measure |
Consulta Implant
n=81 Participants
Patients implanted with a Consulta Cardiac Resynchronization Therapy (CRT)-D device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
15 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.
Percentage of subjects without an unanticipated serious adverse device effects at 1-month post implant.Only subjects implanted with a Consulta device that were followed at least 28 days post-implant or have had a unanticipated device effect within 28 days after implant were included in the analysis.
Outcome measures
| Measure |
Consulta Implant
n=80 Participants
Patients implanted with a Consulta device
|
|---|---|
|
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
|
100 percentage of patients
Interval 90.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 monthNumber of Adverse Events reported in the implanted subjects.
Outcome measures
| Measure |
Consulta Implant
n=80 Participants
Patients implanted with a Consulta device
|
|---|---|
|
Adverse Events
|
70 number of adverse events
|
SECONDARY outcome
Timeframe: 1 month follow-upThe first 20 digital Holter records that were successfully collected in the total of 80 implanted subjects were analysed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
Outcome measures
| Measure |
Consulta Implant
n=20 Participants
Patients implanted with a Consulta device
|
|---|---|
|
System Performance Assessed by Holter Records
|
20 number of Holter recordings
|
SECONDARY outcome
Timeframe: 1 month follow-up94 Save to Disk files were reviewed on observation of device features, ventricular arrhythmia detection times and device classification of ventricular arrhythmias.
Outcome measures
| Measure |
Consulta Implant
n=80 Participants
Patients implanted with a Consulta device
|
|---|---|
|
System Performance Assessed by Save to Disk Files
|
94 number of Save to Disk files
|
SECONDARY outcome
Timeframe: 1 month follow-upReported technical observations will be reviewed to determine if there are any device performance issues.
Outcome measures
| Measure |
Consulta Implant
n=80 Participants
Patients implanted with a Consulta device
|
|---|---|
|
System Performance Assessed by Technical Observations
|
3 number of Technical Observations
|
Adverse Events
Consulta Implant
Serious events: 18 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Consulta Implant
n=80 participants at risk
Patients implanted with a Consulta CRT-D device
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Atrial Fibrillation
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Atypical Angina
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Sinus Tachycardia
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Surgical and medical procedures
Cardiac Perforation
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Cardiac Failure
|
2.5%
2/80 • Number of events 4 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Epistaxis
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Implant site Haematoma
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
5.0%
4/80 • Number of events 4 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Ventricular tachycardia
|
3.8%
3/80 • Number of events 3 • From implant to 1 month follow-up visit
|
|
Congenital, familial and genetic disorders
Perineal abscess
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Renal Failure
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Social circumstances
Suicide
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Ventricular fibrillation
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
Other adverse events
| Measure |
Consulta Implant
n=80 participants at risk
Patients implanted with a Consulta CRT-D device
|
|---|---|
|
Eye disorders
Amaurosis Fugax
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Blood and lymphatic system disorders
Anemia
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
3/80 • Number of events 3 • From implant to 1 month follow-up visit
|
|
Metabolism and nutrition disorders
Increased blood glucose
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Cardiac failure
|
2.5%
2/80 • Number of events 2 • From implant to 1 month follow-up visit
|
|
Nervous system disorders
Syncope
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Palpitations
|
2.5%
2/80 • Number of events 2 • From implant to 1 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
2.5%
2/80 • Number of events 2 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Coronary sinus dissection
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Investigations
Device malfunction
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Nervous system disorders
Dizziness
|
2.5%
2/80 • Number of events 2 • From implant to 1 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.5%
2/80 • Number of events 2 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Cardiac Failure
|
6.2%
5/80 • Number of events 5 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Elevated pacing thresholds
|
5.0%
4/80 • Number of events 4 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Implant site haematoma
|
2.5%
2/80 • Number of events 2 • From implant to 1 month follow-up visit
|
|
Renal and urinary disorders
Herpes Zoster
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Endocrine disorders
Hyperthyroidism
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Implant site pain
|
2.5%
2/80 • Number of events 2 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Inappropriate device programming
|
2.5%
2/80 • Number of events 2 • From implant to 1 month follow-up visit
|
|
Injury, poisoning and procedural complications
Phrenic nerve stimulation
|
3.8%
3/80 • Number of events 3 • From implant to 1 month follow-up visit
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Gastrointestinal disorders
Chest pain
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Respiratory, thoracic and mediastinal disorders
Phlegm
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Presyncope
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
|
Cardiac disorders
Syncope
|
1.2%
1/80 • Number of events 1 • From implant to 1 month follow-up visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic's review to determine whether Confidential Information (CI) is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.
- Publication restrictions are in place
Restriction type: OTHER