Trial Outcomes & Findings for MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure (NCT NCT00262119)
NCT ID: NCT00262119
Last Updated: 2025-07-02
Results Overview
The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1300 participants
Primary outcome timeframe
2 years
Results posted on
2025-07-02
Participant Flow
The recruitment period was between February 2006 and April 2010. Patients were enrolled in cardiology departments.
A total of 1300 patients were enrolled in the study. Enrollment was followed by a 1-month run-in period. Patients with ventricular pacing ≥ 95% on device check in the run-in period were excluded from the study. At the end of the run-in period, randomization was performed. In all, 1166 patients were randomized and followed up.
Participant milestones
| Measure |
Control Group
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
MVP Only
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
DDDRP
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
|---|---|---|---|
|
Overall Study
STARTED
|
385
|
398
|
383
|
|
Overall Study
COMPLETED
|
327
|
328
|
325
|
|
Overall Study
NOT COMPLETED
|
58
|
70
|
58
|
Reasons for withdrawal
| Measure |
Control Group
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
MVP Only
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
DDDRP
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
38
|
51
|
42
|
|
Overall Study
Death
|
20
|
19
|
16
|
Baseline Characteristics
MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
Baseline characteristics by cohort
| Measure |
Control Group
n=385 Participants
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
MVP Only
n=398 Participants
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
DDDRP
n=383 Participants
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
Total
n=1166 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 9 • n=5 Participants
|
74 years
STANDARD_DEVIATION 9 • n=7 Participants
|
74 years
STANDARD_DEVIATION 9 • n=5 Participants
|
74 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
180 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
578 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=5 Participants
|
210 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
588 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
203 participants
n=5 Participants
|
211 participants
n=7 Participants
|
202 participants
n=5 Participants
|
616 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
41 participants
n=5 Participants
|
43 participants
n=7 Participants
|
39 participants
n=5 Participants
|
123 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
17 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
44 participants
n=5 Participants
|
131 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Region of Enrollment
France
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
73 participants
n=4 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Region of Enrollment
Kuwait
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
9 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Switzerland
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Analysis was intention to treat therefore all randomized patients were considered in the analyses
The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.
Outcome measures
| Measure |
Control Group
n=385 Participants
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
MVP Only
n=398 Participants
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
DDDRP
n=383 Participants
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
|---|---|---|---|
|
Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years
|
28.0 percentage of participants
Interval 23.7 to 32.9
|
23.1 percentage of participants
Interval 19.1 to 27.8
|
21.5 percentage of participants
Interval 17.6 to 26.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analysis was intention to treat therefore all randomized patients were included in the analysis
Incidence, estimated via Kaplan Meier survival analysis, of death for any cause at 2 years
Outcome measures
| Measure |
Control Group
n=383 Participants
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
MVP Only
n=398 Participants
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
DDDRP
n=383 Participants
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
|---|---|---|---|
|
Death for All Causes at 2 Years
|
5.6 percentage of participants
Interval 3.6 to 8.5
|
5.1 percentage of participants
Interval 3.3 to 7.9
|
4.6 percentage of participants
Interval 2.8 to 7.3
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: The analysis was intention to treat therefore all randomized patients were analysed
Incidence, estimated via Kaplan Meier survival analysis, of permanent atrial fibrillation at 2 years
Outcome measures
| Measure |
Control Group
n=383 Participants
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
MVP Only
n=398 Participants
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
DDDRP
n=385 Participants
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
|---|---|---|---|
|
Incidence of Permanent Atrial Fibrillation at 2 Years
|
9.2 percentage of participants
Interval 6.6 to 12.7
|
7.7 percentage of participants
Interval 5.3 to 11.0
|
3.8 percentage of participants
Interval 2.2 to 6.5
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Analysis was intention to treat therefore all randomized patients were analysed
Incidence, estimated via Kaplan Meier survival analysis, of cardiovascular hospitalizations at 2 years
Outcome measures
| Measure |
Control Group
n=383 Participants
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
MVP Only
n=398 Participants
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
DDDRP
n=385 Participants
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
|---|---|---|---|
|
Incidence of Cardiovascular Hospitalizations at 2 Years
|
16.8 percentage of participants
Interval 13.3 to 21.2
|
13.7 percentage of participants
Interval 10.5 to 17.7
|
15.2 percentage of participants
Interval 11.8 to 19.4
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
Adverse Events
Control Group
Serious events: 180 serious events
Other events: 0 other events
Deaths: 0 deaths
MVP Only
Serious events: 165 serious events
Other events: 0 other events
Deaths: 0 deaths
DDDRP
Serious events: 169 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=385 participants at risk
PM programming according to actual clinical practice
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
MVP Only
n=398 participants at risk
PM programming according to actual clinical practice + MVP algorithm ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
DDDRP
n=383 participants at risk
PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON
Pacemaker Medtronic EnRhythm: Pacemaker specific programming
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/385
|
1.0%
4/398 • Number of events 4
|
0.00%
0/383
|
|
Blood and lymphatic system disorders
Coagulation problem
|
0.00%
0/385
|
0.25%
1/398 • Number of events 1
|
0.00%
0/383
|
|
Cardiac disorders
Acute Cornary Syndrome/Acute Myocardial Infarction
|
1.8%
7/385 • Number of events 8
|
1.3%
5/398 • Number of events 6
|
1.3%
5/383 • Number of events 5
|
|
Cardiac disorders
Atrial Arrhythmia
|
10.9%
42/385 • Number of events 58
|
12.6%
50/398 • Number of events 71
|
9.9%
38/383 • Number of events 42
|
|
Cardiac disorders
AV conduction disorders
|
0.00%
0/385
|
0.25%
1/398 • Number of events 1
|
0.00%
0/383
|
|
Cardiac disorders
Cardiac death
|
1.8%
7/385 • Number of events 7
|
2.0%
8/398 • Number of events 8
|
2.1%
8/383 • Number of events 8
|
|
Cardiac disorders
General cardiovascular disorders
|
0.52%
2/385 • Number of events 2
|
0.00%
0/398
|
0.52%
2/383 • Number of events 2
|
|
Cardiac disorders
Heart Failure
|
3.4%
13/385 • Number of events 17
|
3.3%
13/398 • Number of events 16
|
3.4%
13/383 • Number of events 16
|
|
Cardiac disorders
Sudden Cardiac Arrest
|
1.0%
4/385 • Number of events 4
|
1.5%
6/398 • Number of events 6
|
0.78%
3/383 • Number of events 3
|
|
Cardiac disorders
Sympthoms of chest pain, angina, palpitation, dyspnea on exertion or cardiopalmo
|
3.4%
13/385 • Number of events 16
|
1.8%
7/398 • Number of events 9
|
2.1%
8/383 • Number of events 8
|
|
Cardiac disorders
Ventricular Tachycardia or Fibrillation
|
0.26%
1/385 • Number of events 1
|
0.25%
1/398 • Number of events 1
|
1.6%
6/383 • Number of events 6
|
|
Endocrine disorders
Glucose metabolism disorders
|
0.78%
3/385 • Number of events 3
|
0.75%
3/398 • Number of events 3
|
0.52%
2/383 • Number of events 2
|
|
Endocrine disorders
Hyperthyroidism
|
0.26%
1/385 • Number of events 1
|
0.00%
0/398
|
0.26%
1/383 • Number of events 1
|
|
Eye disorders
Eye disease
|
0.26%
1/385 • Number of events 1
|
0.00%
0/398
|
0.78%
3/383 • Number of events 3
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.6%
10/385 • Number of events 16
|
1.3%
5/398 • Number of events 6
|
1.8%
7/383 • Number of events 8
|
|
General disorders
Death for non cardiac reason
|
2.6%
10/385 • Number of events 10
|
3.8%
15/398 • Number of events 15
|
2.1%
8/383 • Number of events 8
|
|
General disorders
Death for unknown causes
|
3.9%
15/385 • Number of events 15
|
3.3%
13/398 • Number of events 13
|
6.5%
25/383 • Number of events 25
|
|
General disorders
Hemorrage
|
1.8%
7/385 • Number of events 10
|
1.5%
6/398 • Number of events 7
|
1.3%
5/383 • Number of events 5
|
|
General disorders
Hypertension
|
0.78%
3/385 • Number of events 3
|
1.0%
4/398 • Number of events 4
|
0.26%
1/383 • Number of events 1
|
|
General disorders
Other general disorders
|
5.2%
20/385 • Number of events 24
|
3.5%
14/398 • Number of events 14
|
3.7%
14/383 • Number of events 16
|
|
General disorders
Syncope
|
1.0%
4/385 • Number of events 4
|
1.0%
4/398 • Number of events 4
|
2.1%
8/383 • Number of events 8
|
|
Hepatobiliary disorders
Gallbladdert disorder
|
1.0%
4/385 • Number of events 4
|
0.00%
0/398
|
0.26%
1/383 • Number of events 3
|
|
Hepatobiliary disorders
Hepatic disorder
|
0.26%
1/385 • Number of events 1
|
0.25%
1/398 • Number of events 1
|
0.26%
1/383 • Number of events 1
|
|
Infections and infestations
Infection and infestations
|
0.78%
3/385 • Number of events 4
|
1.0%
4/398 • Number of events 4
|
1.0%
4/383 • Number of events 5
|
|
Injury, poisoning and procedural complications
Consequences of drugs administration
|
1.0%
4/385 • Number of events 4
|
0.25%
1/398 • Number of events 1
|
0.78%
3/383 • Number of events 3
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
4.4%
17/385 • Number of events 19
|
4.5%
18/398 • Number of events 19
|
3.9%
15/383 • Number of events 15
|
|
Injury, poisoning and procedural complications
Pacemaker/Lead related complications
|
1.3%
5/385 • Number of events 5
|
0.75%
3/398 • Number of events 4
|
1.0%
4/383 • Number of events 4
|
|
Injury, poisoning and procedural complications
Ureteral catheter dysfunction or dislodgement
|
0.26%
1/385 • Number of events 10
|
0.00%
0/398
|
0.00%
0/383
|
|
Investigations
Enteroscopy, colonoscopy or video capsule endoscopy procedure
|
0.52%
2/385 • Number of events 3
|
0.00%
0/398
|
0.00%
0/383
|
|
Musculoskeletal and connective tissue disorders
Muscoloskeletal disease
|
6.0%
23/385 • Number of events 33
|
1.3%
5/398 • Number of events 5
|
2.6%
10/383 • Number of events 11
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasia
|
2.1%
8/385 • Number of events 11
|
1.8%
7/398 • Number of events 7
|
1.0%
4/383 • Number of events 4
|
|
Renal and urinary disorders
Prostate disorder
|
0.78%
3/385 • Number of events 3
|
0.50%
2/398 • Number of events 2
|
0.00%
0/383
|
|
Renal and urinary disorders
Renal or urinary disease
|
1.0%
4/385 • Number of events 4
|
1.8%
7/398 • Number of events 9
|
0.78%
3/383 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Edema
|
0.26%
1/385 • Number of events 1
|
0.50%
2/398 • Number of events 2
|
0.78%
3/383 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.78%
3/385 • Number of events 6
|
0.25%
1/398 • Number of events 1
|
0.26%
1/383 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cronic Obstructive Pulmonary Disease
|
0.00%
0/385
|
0.50%
2/398 • Number of events 4
|
0.26%
1/383 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Other respiratory, thoracic and mediastinal disorders
|
0.78%
3/385 • Number of events 3
|
2.0%
8/398 • Number of events 8
|
2.1%
8/383 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.3%
5/385 • Number of events 6
|
1.8%
7/398 • Number of events 10
|
0.78%
3/383 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Symptoms of dyspnea, shortness of breath, fatigue, cough and or tachypnea
|
0.78%
3/385 • Number of events 3
|
1.0%
4/398 • Number of events 7
|
1.0%
4/383 • Number of events 4
|
|
Surgical and medical procedures
Ablation
|
0.52%
2/385 • Number of events 2
|
0.50%
2/398 • Number of events 2
|
0.78%
3/383 • Number of events 3
|
|
Surgical and medical procedures
Coronary Artery Bypass Graft
|
0.78%
3/385 • Number of events 3
|
0.25%
1/398 • Number of events 1
|
0.00%
0/383
|
|
Surgical and medical procedures
Other cardiac surgical interventions
|
0.52%
2/385 • Number of events 3
|
0.75%
3/398 • Number of events 3
|
1.0%
4/383 • Number of events 4
|
|
Surgical and medical procedures
Other surgical interventions
|
2.3%
9/385 • Number of events 11
|
5.3%
21/398 • Number of events 22
|
4.2%
16/383 • Number of events 16
|
|
Surgical and medical procedures
Pacemaker replacement, explant or repositioning
|
4.4%
17/385 • Number of events 17
|
1.8%
7/398 • Number of events 7
|
4.4%
17/383 • Number of events 17
|
|
Surgical and medical procedures
Stent implantation/Angiography
|
1.6%
6/385 • Number of events 6
|
0.75%
3/398 • Number of events 3
|
1.3%
5/383 • Number of events 5
|
|
Vascular disorders
Aneurysm
|
0.00%
0/385
|
0.50%
2/398 • Number of events 2
|
0.26%
1/383 • Number of events 1
|
|
Vascular disorders
Coronary Artery Disease
|
0.52%
2/385 • Number of events 2
|
0.25%
1/398 • Number of events 1
|
0.52%
2/383 • Number of events 2
|
|
Vascular disorders
Other cerebrovascular disorders
|
0.00%
0/385
|
0.00%
0/398
|
0.26%
1/383 • Number of events 1
|
|
Vascular disorders
Other vascular disorders
|
0.00%
0/385
|
0.75%
3/398 • Number of events 4
|
0.26%
1/383 • Number of events 1
|
|
Vascular disorders
Peripheral vascular disease
|
0.26%
1/385 • Number of events 1
|
0.00%
0/398
|
0.00%
0/383
|
|
Vascular disorders
Stroke
|
1.0%
4/385 • Number of events 4
|
0.75%
3/398 • Number of events 3
|
0.52%
2/383 • Number of events 2
|
|
Vascular disorders
Transient Ischemic Attack
|
1.0%
4/385 • Number of events 4
|
1.0%
4/398 • Number of events 4
|
1.0%
4/383 • Number of events 5
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place