Leadless Versus Conventional Pacemakers: Effects on Heart Function and Heart Failure
NCT07929467, Not applicable, Not yet recruiting, Karl Landsteiner University of Health Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Leadless Versus Conventional Pacemakers: Effects on Heart Function and Heart Failure | ClinicalTrials.gov |
| NCT number | NCT07929467 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 760 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Karl Landsteiner University of Health Sciences | ClinicalTrials.gov |
| Conditions | Bradycardia, Atrioventricular Block, Heart Failure, Pacing Induced Cardiomyopathy, Pacing Therapy, Pacing Induced Dyssynchrony, Leadless Pacemaker | ClinicalTrials.gov |
| Interventions | Leadless pacemaker implantation, Conventional transvenous pacemaker implantation | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cumulative incidence of pacing-induced cardiac dysfunction | Up to 12 months after implantation for clinical events; echocardiographic assessments at 6 and 12 months after implantation (each +/-30 days). | Participant-level composite of: (1) LVEF decline of at least 10 percentage points to below 50%, RV pacing burden at least 40%, and no alternative cause; (2) new or worsened symptoms compatible with loss of AV synchrony, reduced AV synchrony, and RV pacing burden at least 40% at the last available interrogation; (3) hospitalization primarily for acute decompensated heart failure requiring IV diuretics and/or vasodilators, with RV pacing burden at least 40%; or (4) CRT upgrade for symptomatic heart failure, LVEF below 50%, and RV pacing burden at least 40%. HF admissions and CRT upgrades use the prespecified interrogation rule and blinded adjudication. Each participant is counted once. Death before PICD is a competing event, not a component. An event at 6 months remains an event at 12 months. LVEF=left ventricular ejection fraction; RV=right ventricular; AV=atrioventricular; CRT=cardiac resynchronization therapy; HF=heart failure; PICD=pacing-induced cardiac dysfunction. | ClinicalTrials.gov |
| Secondary | Change in left ventricular ejection fraction from baseline to 12 months | Baseline (within 14 days before implantation and before randomization) and 12 months after implantation (+/-30 days). | Change in left ventricular ejection fraction (LVEF), expressed in percentage points, assessed by standardized independent echocardiographic evaluation. The treatment contrast is leadless minus transvenous. Non-inferiority requires the lower bound of the two-sided 95% confidence interval to exceed -3.5 percentage points. This is the first key secondary test and is confirmatory only after primary non-inferiority has been established. Handling of death and missing assessments will be prespecified in the statistical analysis plan. | ClinicalTrials.gov |
| Secondary | NT-proBNP at 12 months adjusted for baseline NT-proBNP | Baseline (within 14 days before implantation and before randomization) and 12 months after implantation (+/-30 days) | N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 12 months, analysed on the logarithmic scale with adjustment for baseline NT-proBNP. The treatment contrast is the ratio of adjusted geometric means, leadless divided by transvenous. Non-inferiority requires the upper bound of the two-sided 95% confidence interval to be below 1.5. This is the second key secondary test and is confirmatory only if all preceding tests succeed. Handling of death and missing assessments will be prespecified in the statistical analysis plan. | ClinicalTrials.gov |
| Secondary | Participants with all-cause death, any heart-failure hospitalization, or urgent pacemaker-related reintervention | From implantation up to 12 months after implantation. | Number and percentage of participants with at least one of the following: death from any cause, any heart-failure hospitalization, or urgent pacemaker-related reintervention. Each participant is counted once for the composite. Unlike the primary composite, heart-failure hospitalization in this outcome is not restricted by a right ventricular pacing burden threshold. This is the third key secondary test, assessed for superiority at a two-sided significance level of 0.05 only if all preceding tests succeed; otherwise, the comparison is exploratory. | ClinicalTrials.gov |
| Secondary | Change in left ventricular ejection fraction from baseline to 6 months | Baseline (within 14 days before implantation and before randomization) and 6 months after implantation (+/-30 days). | Change in left ventricular ejection fraction, expressed in percentage points, measured by standardized independent echocardiographic evaluation. This analysis is supportive and is not part of the fixed confirmatory testing sequence. | ClinicalTrials.gov |
| Secondary | Change in NT-proBNP from baseline to 6 months | Baseline (within 14 days before implantation and before randomization) and 6 months after implantation (+/-30 days). | Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration from baseline to 6 months, expressed in pg/mL. This is a supportive biomarker outcome and is not part of the fixed confirmatory testing sequence. | ClinicalTrials.gov |
| Secondary | New York Heart Association functional class | At 6 and 12 months after implantation (each +/-30 days). | Distribution of participants across New York Heart Association (NYHA) functional classes I to IV at each assessment. Class I indicates no limitation of physical activity; class IV indicates symptoms at rest and inability to undertake physical activity without discomfort. Higher classes indicate greater functional limitation. Results are reported separately at 6 and 12 months. | ClinicalTrials.gov |
| Secondary | All-cause mortality | From implantation up to 12 months after implantation. | Number and percentage of participants who die from any cause during follow-up. Mortality is reported separately from the primary pacing-induced cardiac dysfunction outcome. | ClinicalTrials.gov |
| Secondary | Participants with pacing-induced cardiomyopathy | Up to 12 months after implantation, including the 12-month echocardiographic assessment window (+/-30 days); additional assessment at 6 months (+/-30 days). | Number and percentage of participants with an absolute decline in left ventricular ejection fraction of at least 10 percentage points from baseline to below 50%, documented right ventricular pacing burden of at least 40%, and no alternative explanation such as myocardial infarction, myocarditis, or severe valve deterioration. Echocardiographic assessment is performed independently. A qualifying event detected at 6 months remains an event even if ventricular function subsequently improves. | ClinicalTrials.gov |
| Secondary | Participants with heart-failure hospitalization meeting the primary endpoint criteria | From implantation up to 12 months after implantation. | Number and percentage of participants hospitalized with a primary diagnosis of acute decompensated heart failure requiring intravenous diuretics and/or vasodilators, with right ventricular pacing burden of at least 40% established according to the prespecified interrogation rule. Events are confirmed by the blinded clinical events committee. | ClinicalTrials.gov |
| Secondary | Participants with cardiac resynchronization therapy upgrade meeting the primary endpoint criteria | From implantation up to 12 months after implantation. | Number and percentage of participants receiving a cardiac resynchronization therapy system for symptomatic heart failure with left ventricular ejection fraction below 50% and right ventricular pacing burden of at least 40%, established according to the prespecified interrogation rule. Events are confirmed by the blinded clinical events committee. Clinical treatment decisions remain independent of study endpoint classification. | ClinicalTrials.gov |
| Secondary | Participants with any heart-failure hospitalization | From implantation up to 12 months after implantation. | Number and percentage of participants with at least one heart-failure hospitalization, irrespective of whether the right ventricular pacing burden criterion of the primary endpoint is met. Events are assessed according to the prespecified adjudication criteria. | ClinicalTrials.gov |
| Secondary | Participants with urgent pacemaker-related reintervention | From implantation up to 12 months after implantation. | Number and percentage of participants undergoing at least one urgent pacemaker-related reintervention, as defined in the prespecified endpoint manual. This is an individual component of the key secondary clinical composite. | ClinicalTrials.gov |
| Secondary | Right ventricular pacing capture threshold | At 6 and 12 months after implantation (each +/-30 days). | Right ventricular pacing capture threshold measured during device interrogation, expressed in volts. The pulse duration at which the threshold is measured is documented. Values are reported separately at 6 and 12 months. | ClinicalTrials.gov |
| Secondary | Right ventricular sensing amplitude | At 6 and 12 months after implantation (each +/-30 days). | Intrinsic right ventricular sensing amplitude measured during device interrogation, expressed in millivolts. Values are reported separately at 6 and 12 months. | ClinicalTrials.gov |
| Secondary | Right ventricular pacing impedance | At 6 and 12 months after implantation (each +/-30 days). | Right ventricular pacing impedance measured during device interrogation, expressed in ohms. Values are reported separately at 6 and 12 months. | ClinicalTrials.gov |
| Secondary | Estimated remaining pacemaker battery longevity | At 6 and 12 months after implantation (each +/-30 days). | Device-reported estimate of remaining battery longevity, expressed in years, obtained during interrogation. This is an estimated remaining lifespan rather than observed time to battery depletion. Values are reported separately at 6 and 12 months and, where applicable, separately for individual implanted leadless units. | ClinicalTrials.gov |
| Secondary | Right ventricular pacing burden | At 6 and 12 months after implantation (each +/-30 days). | Percentage of ventricular beats paced, obtained from pacemaker interrogation. The device interrogation interval is documented. Values are reported separately at 6 and 12 months. | ClinicalTrials.gov |
| Secondary | Duration of the index pacemaker implantation procedure | Day 0 (during the index pacemaker implantation procedure). | Duration of the index pacemaker implantation procedure, expressed in minutes and recorded according to the study procedural data collection rules. | ClinicalTrials.gov |
| Secondary | Fluoroscopy time during the index implantation | Day 0 (during the index pacemaker implantation procedure). | Total fluoroscopy time during the index pacemaker implantation procedure, expressed in minutes. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)